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
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.
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.
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.

Clinical Trial Conditions for TRETINOIN

Condition Name

Condition Name for TRETINOIN
Intervention	Trials
Acne Vulgaris	25
Leukemia	15
Acne	9
Myelodysplastic Syndromes	6

Condition MeSH

Condition MeSH for TRETINOIN
Intervention	Trials
Acne Vulgaris	28
Leukemia	24
Leukemia, Myeloid, Acute	14
Leukemia, Promyelocytic, Acute	14

Clinical Trial Locations for TRETINOIN

Trials by Country

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Trials by Country for TRETINOIN
Location	Trials
United States	275
Canada	16
Brazil	10
Australia	9
France	8

Trials by US State

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Trials by US State for TRETINOIN
Location	Trials
Pennsylvania	17
North Carolina	16
California	15
Florida	14
New York	13

Clinical Trial Progress for TRETINOIN

Clinical Trial Phase

Clinical Trial Phase for TRETINOIN
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	21
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for TRETINOIN
Clinical Trial Phase	Trials
Completed	72
Unknown status	14
Recruiting	10

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	121
Industry	64
NIH	24

Tretinoin: Clinical Trials, Market Analysis, and Projections

Introduction

Tretinoin, a derivative of vitamin A, is a versatile drug used in both dermatological and oncological treatments. This article delves into the current state of clinical trials involving tretinoin, provides a comprehensive market analysis, and outlines future projections for this drug.

Clinical Trials Update

Acute Promyelocytic Leukemia (APL)

One of the most significant clinical trials involving tretinoin is in the treatment of acute promyelocytic leukemia (APL). A phase III trial is studying the combination of tretinoin and arsenic trioxide for patients with newly diagnosed APL. This treatment aims to reduce the long-term side effects associated with traditional anthracycline chemotherapy by replacing or reducing its use with tretinoin and arsenic trioxide[4].

Other Oncological Trials

Tretinoin is also being investigated in various other cancer treatments. For example, a trial combining tretinoin with atezolizumab for the treatment of recurrent or metastatic non-small cell lung cancer is currently active but not recruiting new participants[1].

Dermatological Trials

In the dermatological sphere, tretinoin is being studied in combination with pembrolizumab for the treatment of advanced melanoma. This phase 1/2 trial is active but not recruiting new participants, highlighting the ongoing interest in tretinoin's potential in immunotherapy combinations[1].

Market Analysis

Current Market Size

The global tretinoin market was valued at approximately $7.631 billion in 2023. According to market research, this figure is expected to grow significantly over the next few years[2].

Growth Projections

The tretinoin market is projected to reach $10.620 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.9% from 2024 to 2030. Another forecast suggests an even more robust growth, with the market size expected to reach $7.5 billion by 2031, growing at a CAGR of 10.1% from 2024 to 2031[2][3].

Market Drivers

Several factors are driving the growth of the tretinoin market:

• Expanding Beauty and Cosmetics Sector: The increasing demand for skincare products, particularly those with anti-aging and skin-renewing properties, is a significant driver[3].
• Prescription Demand: Tretinoin's use in treating specific dermatological conditions, such as acne and photoaging, drives its prescription market[3].
• Patient Preference for Topical Treatments: Patients often prefer topical treatments for skin issues, which fuels the demand for tretinoin-containing products[5].
• Dermatologist Recommendations: Recommendations from dermatologists further increase consumer awareness and demand for tretinoin products[3].

Market Segmentation

The tretinoin market is segmented by type, application, and distribution channel:

• Types: Tretinoin products come in various concentrations, such as 0.1%, 0.02%, 0.025%, and 0.05% formulations[2].
• Applications: The primary applications include skin diseases and leukemia treatments[2].
• Distribution Channels: Products are available through pharmacies, drugstores, prescription dispensing, and online retail platforms[3].

Geographic Market Trends

North America and Europe

These regions have a well-established market for tretinoin, driven by high consumer awareness and the presence of major pharmaceutical companies. The demand for skincare products and prescription medications in these regions continues to drive market growth[3].

Asia-Pacific

The Asia-Pacific region is experiencing rapid growth in the skincare market, driven by increasing disposable income and a growing awareness of skin health. This trend is expected to significantly contribute to the global tretinoin market growth[3].

Middle East, Africa, and Latin America

While these regions have a smaller market share currently, they offer potential for future growth as consumer awareness and disposable income increase[3].

Challenges and Opportunities

Market Restraints

Despite the growth potential, there are several challenges:

• Skin Type Compatibility: Differences in skin types can inhibit the universal applicability of topical tretinoin solutions[5].
• Raw Material Price Fluctuations: Changes in raw material prices can impact the cost of tretinoin drugs, affecting market dynamics[5].

Market Opportunities

• Multi-Functional Cosmetic Products: Developing tretinoin-enriched multi-functional cosmetic products can tap into the expanding skincare market[5].
• Strategic Partnerships: Collaborations with dermatologists and skincare professionals can enhance product credibility and market reach[5].
• Region-Specific Formulations: Developing formulations tailored to diverse climatic and demographic skin concerns can open new market opportunities[5].

Key Takeaways

• Clinical Trials: Tretinoin is being extensively studied in combination with other treatments for various cancers and dermatological conditions.
• Market Growth: The global tretinoin market is expected to grow significantly, driven by the beauty and cosmetics sector, prescription demand, and patient preferences.
• Geographic Trends: North America, Europe, and the Asia-Pacific region are key markets, with potential growth in the Middle East, Africa, and Latin America.
• Challenges and Opportunities: While skin type compatibility and raw material price fluctuations pose challenges, opportunities lie in developing multi-functional products and strategic partnerships.

FAQs

What is the current market size of the tretinoin market?

The global tretinoin market was valued at approximately $7.631 billion in 2023[2].

What is the projected growth rate of the tretinoin market?

The market is expected to grow at a CAGR of 4.9% from 2024 to 2030, or alternatively, at a CAGR of 10.1% from 2024 to 2031[2][3].

What are the primary applications of tretinoin?

The primary applications include skin diseases and leukemia treatments[2].

Which regions are driving the growth of the tretinoin market?

North America, Europe, and the Asia-Pacific region are the key drivers, with potential growth in the Middle East, Africa, and Latin America[3].

What are the main challenges facing the tretinoin market?

Challenges include differences in skin type compatibility and fluctuations in raw material prices[5].

Sources

1. ClinicalTrials.gov: Various clinical trials involving tretinoin.
2. Valuates Reports: Global Tretinoin Market Research Report 2024.
3. Verified Market Research: Tretinoin Market Size, Share, Scope, Trends And Forecast.
4. UCSF Clinical Trials: Tretinoin and Arsenic Trioxide in Treating Patients With Newly Diagnosed Acute Promyelocytic Leukemia.
5. 360 Research Reports: Topical Tretinoin Drugs Market Size & Share 2025-2030.