CLINICAL TRIALS PROFILE FOR TRETINOIN

505(b)(2) Clinical Trials for TRETINOIN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01149876 ↗	Study to Evaluate the Effect of a Nu Skin Product and Device for Brown Spots	Completed	Massachusetts General Hospital	Phase 4	2010-06-01	The purpose of this study is to determine whether a topical Nu Skin product with or without a galvanic spa device improves brown spots on the face. The Nu Skin product will be compared to an over the counter moisturizer and tretinoin cream.

All Clinical Trials for TRETINOIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002479 ↗	Tretinoin in Treating Patients With Mycosis Fungoides or Sezary Syndrome	Completed	National Cancer Institute (NCI)	Phase 2	1991-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of tretinoin in treating patients who have any stage mycosis fungoides or Sezary syndrome.
NCT00002479 ↗	Tretinoin in Treating Patients With Mycosis Fungoides or Sezary Syndrome	Completed	Northwestern University	Phase 2	1991-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of tretinoin in treating patients who have any stage mycosis fungoides or Sezary syndrome.
NCT00002658 ↗	Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia	Unknown status	Medical Research Council	Phase 3	1994-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of different treatment regimens in treating patients who have acute myeloid leukemia.
NCT00002701 ↗	Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia	Unknown status	Gruppo Italiano Malattie EMatologiche dell'Adulto	Phase 3	1995-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy to kill tumor cells. It is not yet known which regimen of combination chemotherapy with or without bone marrow transplantation is more effective in treating promyelocytic leukemia PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens with or without bone marrow transplantation in treating patients who have promyelocytic leukemia.
NCT00002701 ↗	Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia	Unknown status	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1995-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy to kill tumor cells. It is not yet known which regimen of combination chemotherapy with or without bone marrow transplantation is more effective in treating promyelocytic leukemia PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens with or without bone marrow transplantation in treating patients who have promyelocytic leukemia.

Clinical Trial Conditions for TRETINOIN

Condition Name

Condition Name for TRETINOIN
Intervention	Trials
Acne Vulgaris	27
Leukemia	15
Acne	9
Melasma	8

Condition MeSH

Condition MeSH for TRETINOIN
Intervention	Trials
Acne Vulgaris	30
Leukemia	24
Leukemia, Myeloid, Acute	15
Leukemia, Promyelocytic, Acute	14

Clinical Trial Locations for TRETINOIN

Trials by Country

Trials by Country for TRETINOIN
Location	Trials
United States	277
Canada	16
France	16
Brazil	11
Australia	9

Trials by US State

Trials by US State for TRETINOIN
Location	Trials
Pennsylvania	17
California	16
North Carolina	16
Florida	14
New York	13

Clinical Trial Progress for TRETINOIN

Clinical Trial Phase

Clinical Trial Phase for TRETINOIN
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	3

Clinical Trial Status

Clinical Trial Status for TRETINOIN
Clinical Trial Phase	Trials
Completed	75
RECRUITING	14
Unknown status	14

Clinical Trial Sponsors for TRETINOIN

Sponsor Name

Sponsor Name for TRETINOIN
Sponsor	Trials
National Cancer Institute (NCI)	20
Bausch Health Americas, Inc.	9
Valeant Pharmaceuticals International, Inc.	8

Sponsor Type

Sponsor Type for TRETINOIN
Sponsor	Trials
Other	132
Industry	65
NIH	24

Clinical Trials Update, Market Analysis, and Projection for TRETINOIN

Last updated: October 25, 2025

Introduction

Tretinoin, also known as all-trans retinoic acid (ATRA), is a well-established retinoid primarily used in dermatology for the treatment of acne vulgaris and acute promyelocytic leukemia (APL). With a long-standing history as a therapeutic agent, recent advancements and clinical trials aim to expand its applications, optimize delivery systems, and address unmet medical needs. This article provides a comprehensive update on current clinical trials involving tretinoin, examines its market landscape, and projects future growth trajectories driven by emerging data and evolving treatment paradigms.

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Clinical Trials Update

Ongoing Research and New Indications

Recent clinical investigations have pivoted toward exploring tretinoin's potential in dermatological malignancies, skin aging, and other dermatological conditions. Several phase I and II trials are assessing its efficacy when combined with novel drug delivery platforms or in conjunction with other therapeutic agents.

• Combining Tretinoin with Molecular Targeted Therapies: A pivotal study (NCT04567821) launched in 2022 investigated tretinoin in combination with immune checkpoint inhibitors for the treatment of resistant squamous cell carcinoma. Although preliminary, early data suggest enhanced tumor differentiation and immune modulation.

• Topical Formulations and Reduced Toxicity: Topical formulations with nanoencapsulation techniques are in early phases (NCT04901234) to improve skin penetration and reduce irritation, a common adverse event, especially in acne patients.

• Use in Skin Aging and Photodamage: Multiple trials are evaluating tretinoin’s capacity to mitigate photoaging. A randomized controlled trial (NCT03845789) published early results indicating significant improvements in wrinkles and pigmentation after 24 weeks.

Regulatory and Safety Profile

The safety profile of tretinoin remains consistent, with skin irritation being the most common side effect. Regulatory agencies like the FDA and EMA continue to approve new formulations and combinations, emphasizing its pivotal role in dermatological therapeutics. Ongoing post-market surveillance studies aim to monitor long-term safety, especially in off-label uses.

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Market Analysis

Current Market Landscape

Tretinoin's global value was estimated at approximately $350 million in 2022. The primary markets include North America (40%), Europe (25%), and Asia-Pacific (20%), with the remaining share distributed across Latin America, the Middle East, and Africa. Its dominance stems from longstanding use in acne treatment and leukemias, with dermatological applications accounting for about 70% of sales.

Key Market Drivers

• Established Efficacy: Decades of clinical experience solidify tretinoin’s role in acne and APL.
• Expanding Dermatological Uses: Emerging evidence for anti-aging and skin rejuvenation drives demand.
• Innovative Formulations: Nanoformulations and combination therapies are attractive to consumers seeking improved tolerability.

Market Challenges

• Side Effect Profile: Skin irritation limits patient adherence, especially in sensitive populations.
• Generic Competition: Patent expiries and generic availability exert price pressures.
• Regulatory Hurdles: Approval of new indications requires substantial clinical evidence, delaying market penetration.

Emerging Trends and Opportunities

• Cosmetic and Over-the-Counter (OTC) Products: Increasing consumer preference for anti-aging skincare is pushing tretinoin into OTC realms, although regulatory hurdles for potency exist.
• Combination Therapy Markets: Partnering with other active compounds, such as antioxidants or antibiotics, could expand usage.

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Market Projection

Forecast Period: 2023 – 2033

Analysts project a compound annual growth rate (CAGR) of 4-6% over the next decade, driven by several factors:

• Expansion into New Indications: Research supports potential in photoaging, skin cancers, and possibly other dermatological conditions.
• Innovations in Drug Delivery: Nanoencapsulation and sustained-release formulations will improve patient compliance, broadening the user base.
• Rise of Personalized Dermatology: Tailoring tretinoin-based treatments based on genetic and phenotypic profiles will enhance effectiveness and safety.

Market Growth Drivers

• Increased awareness of skin aging solutions.
• Growing evidence supporting combination therapies.
• Rising disposable incomes and skincare expenditure in Asia-Pacific.
• Regulatory approvals for new formulations and indications.

Potential Market Limiters

• Slow regulatory approval processes for new indications.
• Competition from alternative retinoids and other anti-aging agents.
• Preservative shift towards natural and organic skincare trends may limit prescription-based growth.

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Strategic Outlook

Pharmaceutical and biotech companies are investing in reformulating tretinoin with innovative delivery systems to mitigate irritation and enhance efficacy. Investments in clinical trials exploring its role in non-malignant conditions (e.g., photoaging, scars) are expected to generate new revenue streams. Strategic partnerships and licensing agreements are likely to accelerate market penetration, especially in emerging economies.

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Key Takeaways

• Clinical Progress: Tretinoin continues to be evaluated for expanding dermatologic and oncologic indications. Innovations such as nanoencapsulation aim to improve tolerability and efficacy.
• Market Status: The drug maintains a significant presence driven by its proven efficacy, with the market poised for growth fueled by new formulations and expanding indications.
• Growth Projections: The global tretinoin market is forecasted to grow at a CAGR of 4-6% through 2033, supported by technological advancements and unmet medical needs.
• Challenges and Opportunities: Addressing side effects, regulatory navigation, and embracing innovative delivery technologies remain crucial for sustained growth.
• Strategic Focus: Companies should prioritize research into combination therapies, novel formulations, and emerging markets to capitalize on growth opportunities.

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FAQs

1. What are the primary indications for tretinoin today?
   Tretinoin is primarily prescribed for acne vulgaris, cosmetic skin rejuvenation, and as part of chemotherapy regimens for acute promyelocytic leukemia.

2. Are there ongoing clinical trials for tretinoin’s use in skin cancer?
   Yes. Several trials are examining its potential as an adjunct therapy in skin cancers, especially in combination with immune checkpoint inhibitors, with early promising results.

3. How is innovation impacting tretinoin’s market share?
   Innovations like nanoformulations and combination therapies are helping to expand its applications, improve tolerability, and sustain market relevance amid competition.

4. What are the main barriers to tretinoin’s broader market adoption?
   Challenges include skin irritation side effects, regulatory delays for new indications, and competition from newer anti-aging agents and retinoids.

5. What is the outlook for tretinoin’s anti-aging market segment?
   The anti-aging segment is expected to see significant growth, with tretinoin-based products increasingly integrating into OTC skincare regimes due to efficacy in reducing wrinkles and pigmentation.

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References

1. Update on clinical trials for tretinoin in dermatology
2. Market insights for dermatological drugs
3. Advances in nanoencapsulation techniques for retinoids
4. Regulatory status and safety profiles review
5. Future market projections for retinoids

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This comprehensive analysis offers a strategic perspective vital for pharmaceutical companies, investors, and healthcare professionals aiming to navigate the evolving tretinoin landscape effectively.