# Tretinoin

Tretinoin is FDA-approved by prescription on the skin for acne and fine facial wrinkles, and by mouth for one kind of leukemia. For acne the evidence grade is strong-human. The capsule label warns it can harm an unborn baby. It is not approved to reverse skin ageing.

Status checked: 2026-10-26. Last verified: 2026-10-26. Primary source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020475

This page has not been individually reviewed by a clinician.

Information, not medical advice.

| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | all-trans retinoic acid, Retin-A, Vesanoid | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020475Orig1s029lbl.pdf) |
| Class | non-peptide | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020475Orig1s029lbl.pdf) |
| Regulatory status | fda-approved | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020475) |
| Status source read | 2026-10-26 | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020475) |
| Evidence grade | strong-human | our assessment | 2026-10-26 | [source](https://peptideindex.ai/methodology#evidence-grade) |
| Label dosing | From the Retin-A Micro, Altreno, Renova and Vesanoid labels. Retin-A Micro gel: a thin layer on the acne areas once a day in the evening. Altreno lotion: a thin layer on the acne areas once a day. Renova cream: a pearl-sized amount on the face once a day in the evening, with sunscreen in the morning. The labels say using more will not bring faster or better results. Vesanoid capsules for acute promyelocytic leukemia: 22.5 mg/m2 by mouth twice a day with a meal, stopped 30 days after remission or after 90 days, whichever comes first. A negative pregnancy test is required first. The prescriber sets the dose. | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020438s009lbl.pdf) |

## Name

Tretinoin

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020475Orig1s029lbl.pdf

## Summary

A vitamin A substance approved as a prescription skin product for acne and fine facial wrinkles, and as a capsule for one kind of leukemia.

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020475Orig1s029lbl.pdf

## Short answer

Tretinoin is FDA-approved by prescription on the skin for acne and fine facial wrinkles, and by mouth for one kind of leukemia. For acne the evidence grade is strong-human. The capsule label warns it can harm an unborn baby. It is not approved to reverse skin ageing.

Source: https://peptideindex.ai/methodology#short-answer

## Known risks

- The capsule label opens with its strongest warning. Tretinoin by mouth can cause miscarriage and birth defects [^4].
- Before starting the capsules, a woman who could become pregnant must have a negative pregnancy test. She must use two kinds of birth control during treatment and for 1 month after [^4].
- About 26% of leukemia patients on the capsules got a reaction called differentiation syndrome. It causes fever, trouble breathing and fluid build-up, and it can be fatal [^4].
- The capsules can raise pressure inside the skull, mostly in children. They can also raise blood fats, harm the liver and cause blood clots [^4].
- On the skin, tretinoin can cause dryness, redness and peeling. It can also cause swelling, itching, blisters, burning or stinging [^1].
- Tretinoin on the skin makes sunburn more likely. The labels say to limit sun and use sunscreen of SPF 15 or more [^1] [^3].
- Acne can look worse in the first weeks of treatment [^1].
- Darker or lighter patches of skin have been reported with repeated use [^1].
- The Renova label says not to use it in pregnancy. It lists 30 reports of birth defects after another skin form, with no proven link [^3].
- The Altreno lotion holds fish proteins. Its label urges care for people allergic to fish [^2].
- A large VA trial of tretinoin cream was stopped early because more people died in the tretinoin group. The authors did not conclude the cream caused the deaths [^17].
- FDA recall records list compounded tretinoin creams recalled from 2017 to 2020. Reasons included no assurance the product was sterile [^10].

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020438s009lbl.pdf

## What nobody knows yet

- Daily Renova use for more than 52 weeks has not been studied enough. Its label says the effects past that point are not known [^3].
- Some people on a stronger cream for over 48 weeks had unusual changes in skin cells. The label says what this means is unknown [^3].
- Some mice given tretinoin on the skin for 91 weeks got skin tumors. Tretinoin may also help UV light cause tumors in mice. The label says the meaning for people is not clear [^1].
- It is unclear why more people died on tretinoin in the VA trial. The authors called a direct cause unlikely, but did not rule it out [^17] [^22].
- A 2015 review of 654 pregnancies found no clear rise in birth defects after skin use. It was too small to rule out a risk [^18].
- In one Renova study of 107 people with darker skin, fewer improved with the cream than with a dummy cream. The study may have been too small to tell [^3].

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021108s015lbl.pdf

## What it is

Tretinoin is a substance the body makes from vitamin A, also called all-trans retinoic acid [^1] [^3]. It is not a peptide. It is the active part of prescription gels and lotions for acne [^1] [^2]. One cream is approved to soften fine facial wrinkles [^3].

Tretinoin also comes as a capsule taken by mouth [^4]. The capsule treats acute promyelocytic leukemia, a blood cancer [^4]. Brand names include Retin-A Micro, Altreno, Renova and Vesanoid [^5] [^6] [^7] [^8].

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020475Orig1s029lbl.pdf

## Where it stands legally

Tretinoin is FDA-approved: Drugs@FDA lists prescription products put on the skin and capsules taken by mouth [^5] [^6] [^7] [^8]. The skin gel and lotion are approved for acne [^1] [^2]. Renova cream is approved only as an add-on to soften fine facial wrinkles, along with sun protection [^3]. The capsules are approved for one kind of leukemia [^4]. The approval does not cover reversing skin ageing. Renova's label says it does not remove wrinkles or repair sun damage [^3]. Checked 26 October 2026.

The approved products named here need a prescription [^5] [^6] [^7]. Vesanoid, the brand-name capsule, is listed as discontinued [^8]. Drugs@FDA notes a Federal Register finding that it was not stopped for safety or effectiveness reasons [^8]. In December 2025, FDA posted draft advice for companies that want to make generic tretinoin cream [^9].

Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug [^11]. Tretinoin is not on FDA's 503A category list [^12]. It is not among the substances FDA says may present significant safety risks [^13].

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020475

## What the evidence shows

The evidence grade is strong-human for acne [^1] [^2] [^15]. In two 12-week trials, the 0.1% gel cut acne spots by 32% to 45%, against 16% to 23% on a dummy gel [^1]. In two trials of 1,640 people aged 9 and over, the 0.05% lotion helped more than a dummy lotion [^2] [^15]. After 12 weeks, 16.5% on the lotion were clear or almost clear in one trial, against 6.9% on the dummy [^2].

For fine wrinkles, the support is narrower. In Renova's trials, 25% of lightly pigmented users had mild or moderate gains, against 12% on a dummy cream [^3]. The label says Renova has not shown an effect on deep wrinkles, dark spots or sagging skin [^3]. A two-year trial of a 0.05% cream in 204 people found more gains than a dummy cream for sun-damaged facial skin [^14]. Renova today is a 0.02% cream [^3].

For acute promyelocytic leukemia, 36% to 80% of patients on the capsules went into remission in the label's studies [^4]. A 2013 trial found retinoic acid with arsenic trioxide did at least as well as retinoic acid with chemotherapy [^16]. In pregnant rats, retinoic acid put on the skin in a solvent harmed the mothers [^19].

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020475Orig1s029lbl.pdf

## Legitimate ways to get it

The legal way to get tretinoin is a prescription for an FDA-approved product [^5] [^6] [^7] [^8]. For acne, that includes Retin-A Micro gel and Altreno lotion [^1] [^2] [^5] [^6]. For fine facial wrinkles, it is Renova cream, used with sun protection [^3] [^7]. For one kind of leukemia, it is capsules by mouth [^4] [^8].

Pharmacies may compound with a raw substance that is part of an FDA-approved drug [^11].

One US study in Utah is testing tretinoin on the skin to prevent a rash caused by some cancer drugs [^20]. One US study in Texas gives tretinoin with other drugs for acute promyelocytic leukemia [^21]. The trials block on this page lists open trials with their dates.

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020475

## How people are getting it anyway

This section describes what happens and is not a recommendation.

Some pharmacies mix tretinoin into custom creams. Some mixes add other drugs, such as hydroquinone or clindamycin [^10]. FDA recall records list several of these creams from 2017 to 2020 [^10]. In some, there was no proof the cream was sterile [^10]. Others lacked good process controls [^10].

Some liquids made by pharmacies also mixed tretinoin with minoxidil and fluocinolone. Some added finasteride too [^10]. In 2020, two such formulas were recalled for weak process controls [^10].

Source: https://api.fda.gov/drug/enforcement.json?search=product_description:tretinoin&limit=20

## Access routes

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020475

### Approved product

Detail: Approved by FDA as a prescription gel put on the skin, in four strengths.

Brand names: Retin-A Micro

Manufacturer: Bausch

Indication: Acne in adults and children 12 years and older.

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020475

### Approved product

Detail: Approved by FDA as a prescription 0.05% lotion put on the skin.

Brand names: Altreno

Manufacturer: Dow Pharm

Indication: Acne in people 9 years and older.

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209353

### Approved product

Detail: Approved by FDA as a prescription 0.02% cream for the face, used with sun protection. Not approved to remove wrinkles or repair sun damage.

Brand names: Renova

Manufacturer: Valeant Pharms North

Indication: An add-on to soften fine facial wrinkles in people who use full skin care and avoid the sun.

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021108

### Approved product

Detail: Approved by FDA as a prescription capsule taken by mouth. The brand is discontinued, not for safety or effectiveness reasons.

Brand names: Vesanoid

Manufacturer: Cheplapharm

Indication: To bring acute promyelocytic leukemia into remission, in adults and children 1 year and older, when anthracycline chemotherapy failed, stopped working or cannot be used.

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020438

### Lawful compounding

Detail: Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug.

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

## Unofficial channels

Source: https://api.fda.gov/drug/enforcement.json?search=product_description:tretinoin&limit=20

### Compounding outside the rules

What it is: Compounded tretinoin creams and mixes made by pharmacies, sometimes with other drugs such as hydroquinone, clindamycin or minoxidil.

Legal position: A pharmacy may compound with a substance that meets a USP standard or is part of an FDA-approved drug. (source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act)

Documented risks:

- FDA recall records list compounded tretinoin creams and gels recalled for lack of assurance that they were sterile. (source: https://api.fda.gov/drug/enforcement.json?search=product_description:tretinoin&limit=20)

Enforcement:

- 2017-02-10: FDA recall records list a recall of compounded tretinoin creams and gels in all strengths for lack of assurance of sterility. (source: https://api.fda.gov/drug/enforcement.json?search=product_description:tretinoin&limit=20)
- 2020-07-02: FDA recall records list a recall of compounded formulas mixing minoxidil, tretinoin and fluocinolone, for weak process controls. (source: https://api.fda.gov/drug/enforcement.json?search=product_description:tretinoin&limit=20)

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

## Recruiting trials

Snapshot date: 2026-10-26.

A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.

- nct NCT07848568, url https://clinicaltrials.gov/study/NCT07848568, phase Phase 1/Phase 2, title Testing Safe Doses of Anti-Cancer Medicines, 5-Flurouracil (5-FU) and Tretinoin (ATRA), Added to the Usual Cancer Treatment of Ependymoma, status not-yet-recruiting, sponsor Children's Oncology Group, countries none listed, us states none listed
- nct NCT07842887, url https://clinicaltrials.gov/study/NCT07842887, phase Phase 1, title Phase 1 Study of ATRA Plus a PD-1 Inhibitor in EGFR-Mutant NSCLC After Third-Generation EGFR-TKI Resistance, status not-yet-recruiting, sponsor Cancer Institute and Hospital, Chinese Academy of Medical Sciences, countries China, us states none listed
- nct NCT07779811, url https://clinicaltrials.gov/study/NCT07779811, phase Phase 2, title Topical Metformin Versus Triple Regimen for Epidermal Melasma, status not-yet-recruiting, sponsor Combined Military Hospital, Pakistan, countries Pakistan, us states none listed
- nct NCT07732192, url https://clinicaltrials.gov/study/NCT07732192, phase Phase 4, title Oral Tranexamic Acid Plus Triple Combination vs Triple Combination Alone in Melasma, status not-yet-recruiting, sponsor Combined Military Hospital Abbottabad, countries none listed, us states none listed
- nct NCT07504458, url https://clinicaltrials.gov/study/NCT07504458, phase Phase 3, title Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia, status recruiting, sponsor Quetzal Therapeutics, countries United States, France, Italy, Romania, Spain, us states Alabama, California, Georgia, Kentucky, Maryland, Michigan, New York, North Carolina, Ohio, Tennessee, Texas, Virginia
- nct NCT07626398, url https://clinicaltrials.gov/study/NCT07626398, phase Phase 2/Phase 3, title All-Trans Retinoic Acid for the Treatment of Hemophagocytic Lymphohistiocytosis, status not-yet-recruiting, sponsor Beijing Anzhen Hospital, countries none listed, us states none listed
- nct NCT07597395, url https://clinicaltrials.gov/study/NCT07597395, phase Phase 3, title ATRA for Management of Primary ITP, status not-yet-recruiting, sponsor Peking University People's Hospital, countries China, us states none listed
- nct NCT07348107, url https://clinicaltrials.gov/study/NCT07348107, phase Phase 1, title ATRA and SDK002 in Combination With Chemotherapy and Anti-PD-1 Inhibitor in Patients With Advanced Pancreatic Ductal Adenocarcinoma., status not-yet-recruiting, sponsor Daniel Breadner, countries Canada, us states none listed
- nct NCT07137130, url https://clinicaltrials.gov/study/NCT07137130, phase Not applicable, title Secretome TGF Beta 3, status not-yet-recruiting, sponsor Universitas Indonesia, countries Indonesia, us states none listed
- nct NCT07355855, url https://clinicaltrials.gov/study/NCT07355855, phase Phase 2, title A Clinical Study on the Efficacy and Safety of All-trans Retinoic Acid Combined With VAC Regimen in the Treatment of Intermediate-to-high-risk Rhabdomyosarcoma, status not-yet-recruiting, sponsor Fudan University, countries China, us states none listed
- nct NCT07296445, url https://clinicaltrials.gov/study/NCT07296445, phase Phase 3, title A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301), status not-yet-recruiting, sponsor SDK Therapeutics, Inc., countries none listed, us states none listed
- nct NCT07366229, url https://clinicaltrials.gov/study/NCT07366229, phase Phase 2, title Topical Application of Engineered Lactobacillus Reuteri With a Zinc Sulfate-Tannic Acid MPN Coating for Acne, status recruiting, sponsor Shenzhen People's Hospital, countries China, us states none listed
- nct NCT07586826, url https://clinicaltrials.gov/study/NCT07586826, phase Phase 2, title Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors, status recruiting, sponsor Peking University People's Hospital, countries China, us states none listed
- nct NCT07586813, url https://clinicaltrials.gov/study/NCT07586813, phase Phase 2, title Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors, status recruiting, sponsor Peking University People's Hospital, countries China, us states none listed
- nct NCT07278908, url https://clinicaltrials.gov/study/NCT07278908, phase Phase 2/Phase 3, title Avatrombopag Combined With All-trans Retinoic Acid in the Treatment of Primary Immune Thrombocytopenia, status not-yet-recruiting, sponsor Institute of Hematology & Blood Diseases Hospital, China, countries none listed, us states none listed
- nct NCT06528769, url https://clinicaltrials.gov/study/NCT06528769, phase Phase 2, title Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma, status recruiting, sponsor Gabriel Tinoco, countries United States, us states Ohio
- nct NCT07154030, url https://clinicaltrials.gov/study/NCT07154030, phase Phase 1, title Efficacy Of Combined Microneedling Plus Tretinoin In Treatment Of Stria Rubra, status not-yet-recruiting, sponsor Sohag University, countries none listed, us states none listed
- nct NCT07079696, url https://clinicaltrials.gov/study/NCT07079696, phase Phase 2, title Investigating the Therapeutic Efficacy of All-trans Retinoic Acid in Autism Spectrum Disorder Patients With 15q11-13 Duplication Syndrome, status not-yet-recruiting, sponsor Second Affiliated Hospital, Zhejiang University, School of Medicine, countries China, us states none listed
- nct NCT07142070, url https://clinicaltrials.gov/study/NCT07142070, phase Not applicable, title Effect of Systemic Retinoic Acid Use on Micro Ribonucleic Acid (mRNA) Expression, status not-yet-recruiting, sponsor Medipol University, countries Turkey (Türkiye), us states none listed
- nct NCT07503730, url https://clinicaltrials.gov/study/NCT07503730, phase Phase 3, title Early Use of Realgar-Indigo Naturalis Formula (RIF) Combined With All-trans Retinoic Acid (ATRA) for Treating Acute Promyelocytic Leukemia (APL)., status recruiting, sponsor First Affiliated Hospital Xi'an Jiaotong University, countries China, us states none listed
- nct NCT06925386, url https://clinicaltrials.gov/study/NCT06925386, phase Phase 2, title The Relationship Between Microbioma Balance and Acne Vulgaris as a New Acne Treatment, status not-yet-recruiting, sponsor Universitas Padjadjaran, countries Indonesia, us states none listed
- nct NCT06447480, url https://clinicaltrials.gov/study/NCT06447480, phase Phase 3, title Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients, status recruiting, sponsor Centre Hospitalier Universitaire de Nice, countries France, French Guiana, us states none listed
- nct NCT06698263, url https://clinicaltrials.gov/study/NCT06698263, phase Phase 4, title 13-cis Retinoic Acid (Isotretinoin) and Sperm Production, status not-yet-recruiting, sponsor University Hospital, Strasbourg, France, countries France, us states none listed
- nct NCT06706401, url https://clinicaltrials.gov/study/NCT06706401, phase Phase 3, title Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma, status recruiting, sponsor Centre Leon Berard, countries France, us states none listed
- nct NCT06358677, url https://clinicaltrials.gov/study/NCT06358677, phase Phase 2, title Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Patients With Solid Tumors, status recruiting, sponsor University of Utah, countries United States, us states Utah
- nct NCT06780644, url https://clinicaltrials.gov/study/NCT06780644, phase Not applicable, title Comparison of Effectiveness and Safety of Triple Combination Cream of Fucinolone Acetonide 0.01%, Hydroquinone 4%, Tretinoin 0.05% with Mometasone Furoate 0.1%, Hydroquinone 4%, Tretinoin 0.05% in the Treatment of Melasma, status not-yet-recruiting, sponsor Universitas Indonesia, countries Indonesia, us states none listed
- nct NCT06841952, url https://clinicaltrials.gov/study/NCT06841952, phase Not applicable, title Study of Tretinoin Capsules in Combination With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia, status not-yet-recruiting, sponsor The First Affiliated Hospital of Soochow University, countries China, us states none listed
- nct NCT06731140, url https://clinicaltrials.gov/study/NCT06731140, phase Phase 2, title Reverse HER2-negative Immune Resistant Breast Cancer, status recruiting, sponsor Fudan University, countries China, us states none listed
- nct NCT06646666, url https://clinicaltrials.gov/study/NCT06646666, phase Phase 2, title ARTA-based Chemo-free Bridging/Maintenance Therapy in CAR-T Treatment for High-Risk R/R B-NHL Ineligible for HDCT and ASCT, status not-yet-recruiting, sponsor Ruijin Hospital, countries China, us states none listed
- nct NCT05474859, url https://clinicaltrials.gov/study/NCT05474859, phase Phase 1, title Subjects With Advanced or Metastatic Solid Tumor Malignancies, status not-yet-recruiting, sponsor Xenthera, Inc., countries none listed, us states none listed
- nct NCT06703047, url https://clinicaltrials.gov/study/NCT06703047, phase Phase 2, title Tislelizumab Combined with Chemotherapy and All Trans Retinoic Acid for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma, status not-yet-recruiting, sponsor Fudan University, countries none listed, us states none listed
- nct NCT06484920, url https://clinicaltrials.gov/study/NCT06484920, phase Phase 2, title A Phase II Study of the Combination of Pembrolizumab and ATRA Combination Treatment of Relapsed HL and B-NHL, status recruiting, sponsor Rita Assi, countries United States, us states Indiana
- nct NCT06636981, url https://clinicaltrials.gov/study/NCT06636981, phase Phase 2, title All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi-cohort Phase II Trial, status recruiting, sponsor Fudan University, countries China, us states none listed
- nct NCT06371274, url https://clinicaltrials.gov/study/NCT06371274, phase Not applicable, title A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC., status recruiting, sponsor First Affiliated Hospital of Zhejiang University, countries China, us states none listed
- nct NCT06536413, url https://clinicaltrials.gov/study/NCT06536413, phase Phase 1/Phase 2, title ATRA and Carfilzomib in Plasma Cell Myeloma Patients, status recruiting, sponsor The Methodist Hospital Research Institute, countries United States, us states Texas
- nct NCT06439888, url https://clinicaltrials.gov/study/NCT06439888, phase Phase 1/Phase 2, title Lymphocyte Support to SBRT in Patients With Oligo-metastatic Solid Cancer, status recruiting, sponsor Gustave Roussy, Cancer Campus, Grand Paris, countries France, us states none listed
- nct NCT06172296, url https://clinicaltrials.gov/study/NCT06172296, phase Phase 3, title Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma, status recruiting, sponsor National Cancer Institute (NCI), countries United States, Australia, Canada, New Zealand, Puerto Rico, us states Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin
- nct NCT06274164, url https://clinicaltrials.gov/study/NCT06274164, phase Not stated, title Clinical and Molecular Biomarker Studies in RAI1 (Retinoic Acid-Induced 1) -Related Disorders, status recruiting, sponsor Baylor College of Medicine, countries United States, us states Texas
- nct NCT06158412, url https://clinicaltrials.gov/study/NCT06158412, phase Phase 2, title All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma, status recruiting, sponsor The First Affiliated Hospital of Xiamen University, countries China, us states none listed
- nct NCT05553782, url https://clinicaltrials.gov/study/NCT05553782, phase Early phase 1, title Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers, status recruiting, sponsor Brigham and Women's Hospital, countries United States, us states Massachusetts
- nct NCT06982274, url https://clinicaltrials.gov/study/NCT06982274, phase Phase 2, title Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia, status recruiting, sponsor Instituto do Cancer do Estado de São Paulo, countries Brazil, us states none listed
- nct NCT05881265, url https://clinicaltrials.gov/study/NCT05881265, phase Phase 2, title Treatment of Chidamide and Venetoclax for Retinoic Acid and Arsenic Resistant Acute Promyelocytic Leukemia, status recruiting, sponsor Shanghai Jiao Tong University School of Medicine, countries China, us states none listed
- nct NCT05345002, url https://clinicaltrials.gov/study/NCT05345002, phase Phase 2, title All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma, status recruiting, sponsor Stephen Bagley, MD, MSCE, countries United States, us states Pennsylvania
- nct NCT05384821, url https://clinicaltrials.gov/study/NCT05384821, phase Phase 1/Phase 2, title Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906), status recruiting, sponsor Centre Oscar Lambret, countries France, us states none listed
- nct NCT04897490, url https://clinicaltrials.gov/study/NCT04897490, phase Not stated, title RWE of 1st Line Treatment With ATO/ATRA for Adult APL, status recruiting, sponsor Grupo Argentino de Tratamiento de la Leucemia Aguda, countries Argentina, us states none listed
- nct NCT04793919, url https://clinicaltrials.gov/study/NCT04793919, phase Phase 2, title Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia, status recruiting, sponsor Associazione Italiana Ematologia Oncologia Pediatrica, countries Belgium, Czechia, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Portugal, Spain, Sweden, us states none listed
- nct NCT03126916, url https://clinicaltrials.gov/study/NCT03126916, phase Phase 3, title Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL), status recruiting, sponsor Children's Oncology Group, countries United States, Canada, Puerto Rico, us states Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin
- nct NCT01409161, url https://clinicaltrials.gov/study/NCT01409161, phase Phase 2, title Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia, status recruiting, sponsor M.D. Anderson Cancer Center, countries United States, us states Texas

Source: https://clinicaltrials.gov/api/v2/studies?query.intr=tretinoin&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState

## Sources

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020475Orig1s029lbl.pdf

### 1. Retin-A Micro (tretinoin) gel label, revised September 2025

Type: label

Tier: primary

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020475Orig1s029lbl.pdf

### 2. Altreno (tretinoin) lotion label, revised August 2018

Type: label

Tier: primary

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209353s000lbl.pdf

### 3. Renova (tretinoin) cream 0.02% label

Type: label

Tier: primary

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021108s015lbl.pdf

### 4. Vesanoid (tretinoin) capsules label, revised October 2024

Type: label

Tier: primary

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020438s009lbl.pdf

### 5. Drugs@FDA: Retin-A Micro (tretinoin) gel, application 020475

Type: regulatory

Tier: primary

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020475

### 6. Drugs@FDA: Altreno (tretinoin) lotion, application 209353

Type: regulatory

Tier: primary

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209353

### 7. Drugs@FDA: Renova (tretinoin) cream, application 021108

Type: regulatory

Tier: primary

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021108

### 8. Drugs@FDA: Vesanoid (tretinoin) capsules, application 020438

Type: regulatory

Tier: primary

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020438

### 9. FDA draft product-specific guidance on tretinoin cream, December 2025

Type: regulatory

Tier: primary

Source: https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017340.pdf

### 10. FDA drug enforcement reports (openFDA): recalls naming tretinoin

Type: regulatory

Tier: primary

Source: https://api.fda.gov/drug/enforcement.json?search=product_description:tretinoin&limit=20

### 11. FDA: bulk drug substances used in compounding under section 503A

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

### 12. FDA: 503A bulk drug substances category list

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/94155/download

### 13. FDA: bulk drug substances that may present significant safety risks (Category 2)

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

### 14. Two-year randomized trial: tretinoin 0.05% cream against placebo in sun-damaged facial skin, 2005

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/16060712/

### 15. Analysis of two randomized phase 3 trials: tretinoin 0.05% lotion in acne, by sex and race, 2019

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/31741356/

### 16. Randomized phase 3 trial: retinoic acid with arsenic trioxide against retinoic acid with chemotherapy in acute promyelocytic leukemia, 2013

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/23841729/

### 17. VA randomized trial: topical tretinoin and death from any cause in 1131 veterans, 2009

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/19153339/

### 18. Systematic review: pregnancy outcomes after first-trimester exposure to topical retinoids, 2015

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/26215715/

### 19. Study in pregnant rats: retinoic acid on the skin and fetal outcome, 1990

Type: animal

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/2136048/

### 20. ClinicalTrials.gov NCT06358677: topical tretinoin to prevent skin toxicity from anti-EGFR cancer drugs

Type: reference

Tier: primary

Source: https://clinicaltrials.gov/study/NCT06358677

### 21. ClinicalTrials.gov NCT01409161: tretinoin and arsenic trioxide in acute promyelocytic leukemia

Type: reference

Tier: primary

Source: https://clinicaltrials.gov/study/NCT01409161

### 22. HealthDay via ABC News: acne cream not linked to raised death risk, January 2009

Type: reference

Tier: established-news

Source: https://abcnews.go.com/Health/Healthday/story?id=6720751&page=1

Last verified: 2026-10-26.

Sources:

- https://api.fda.gov/drug/enforcement.json?search=product_description:tretinoin&limit=20
- https://clinicaltrials.gov/api/v2/studies?query.intr=tretinoin&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState
- https://peptideindex.ai/methodology#evidence-grade
- https://peptideindex.ai/methodology#short-answer
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021108s015lbl.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020438s009lbl.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020475Orig1s029lbl.pdf
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020475

[^1]: Retin-A Micro (tretinoin) gel label, revised September 2025 https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020475Orig1s029lbl.pdf
[^2]: Altreno (tretinoin) lotion label, revised August 2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209353s000lbl.pdf
[^3]: Renova (tretinoin) cream 0.02% label https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021108s015lbl.pdf
[^4]: Vesanoid (tretinoin) capsules label, revised October 2024 https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020438s009lbl.pdf
[^5]: Drugs@FDA: Retin-A Micro (tretinoin) gel, application 020475 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020475
[^6]: Drugs@FDA: Altreno (tretinoin) lotion, application 209353 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209353
[^7]: Drugs@FDA: Renova (tretinoin) cream, application 021108 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021108
[^8]: Drugs@FDA: Vesanoid (tretinoin) capsules, application 020438 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020438
[^9]: FDA draft product-specific guidance on tretinoin cream, December 2025 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017340.pdf
[^10]: FDA drug enforcement reports (openFDA): recalls naming tretinoin https://api.fda.gov/drug/enforcement.json?search=product_description:tretinoin&limit=20
[^11]: FDA: bulk drug substances used in compounding under section 503A https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
[^12]: FDA: 503A bulk drug substances category list https://www.fda.gov/media/94155/download
[^13]: FDA: bulk drug substances that may present significant safety risks (Category 2) https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
[^14]: Two-year randomized trial: tretinoin 0.05% cream against placebo in sun-damaged facial skin, 2005 https://pubmed.ncbi.nlm.nih.gov/16060712/
[^15]: Analysis of two randomized phase 3 trials: tretinoin 0.05% lotion in acne, by sex and race, 2019 https://pubmed.ncbi.nlm.nih.gov/31741356/
[^16]: Randomized phase 3 trial: retinoic acid with arsenic trioxide against retinoic acid with chemotherapy in acute promyelocytic leukemia, 2013 https://pubmed.ncbi.nlm.nih.gov/23841729/
[^17]: VA randomized trial: topical tretinoin and death from any cause in 1131 veterans, 2009 https://pubmed.ncbi.nlm.nih.gov/19153339/
[^18]: Systematic review: pregnancy outcomes after first-trimester exposure to topical retinoids, 2015 https://pubmed.ncbi.nlm.nih.gov/26215715/
[^19]: Study in pregnant rats: retinoic acid on the skin and fetal outcome, 1990 https://pubmed.ncbi.nlm.nih.gov/2136048/
[^20]: ClinicalTrials.gov NCT06358677: topical tretinoin to prevent skin toxicity from anti-EGFR cancer drugs https://clinicaltrials.gov/study/NCT06358677
[^21]: ClinicalTrials.gov NCT01409161: tretinoin and arsenic trioxide in acute promyelocytic leukemia https://clinicaltrials.gov/study/NCT01409161
[^22]: HealthDay via ABC News: acne cream not linked to raised death risk, January 2009 https://abcnews.go.com/Health/Healthday/story?id=6720751&page=1