CLINICAL TRIALS PROFILE FOR DIFFERIN

505(b)(2) Clinical Trials for differin

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
New Formulation	NCT03615768 ↗	A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris	Completed	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited	Phase 3	2018-08-14	This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
New Formulation	NCT03615768 ↗	A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris	Completed	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.	Phase 3	2018-08-14	This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
New Formulation	NCT03615768 ↗	A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris	Completed	Lee's Pharmaceutical Limited	Phase 3	2018-08-14	This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.

All Clinical Trials for differin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00160394 ↗	Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris	Completed	GlaxoSmithKline	Phase 4	2004-12-01	Comparing the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.
NCT00160394 ↗	Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris	Completed	Stiefel, a GSK Company	Phase 4	2004-12-01	Comparing the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.
NCT00237978 ↗	Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)	Unknown status	Technische Universität Dresden	Phase 4	2006-09-01	The aim of the study is to investigate the effectivity of visible light in combination with waterfiltered infrared in treating acne papulopustulosa. The reduction of inflammatory and non-inflammatory lesions within 8 weeks will be measured and compared with the standard treatment with Adapalene.

Clinical Trial Conditions for differin

Condition Name

Condition Name for differin
Intervention	Trials
Acne Vulgaris	16
Skin Manifestations	2
Healthy Skin	1

Condition MeSH

Condition MeSH for differin
Intervention	Trials
Acne Vulgaris	18
Skin Manifestations	2

Clinical Trial Locations for differin

Trials by Country

Trials by Country for differin
Location	Trials
United States	42
Germany	2
Belize	2
Poland	1
India	1

Trials by US State

Trials by US State for differin
Location	Trials
North Carolina	5
Texas	5
California	4
Ohio	3
Michigan	3

Clinical Trial Progress for differin

Clinical Trial Phase

Clinical Trial Phase for differin
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	4
Phase 1	5

Clinical Trial Status

Clinical Trial Status for differin
Clinical Trial Phase	Trials
Completed	18
Withdrawn	2
Not yet recruiting	1

Clinical Trial Sponsors for differin

Sponsor Name

Sponsor Name for differin
Sponsor	Trials
Galderma Laboratories, L.P.	5
GlaxoSmithKline	2
Stiefel, a GSK Company	2

Sponsor Type

Sponsor Type for differin
Sponsor	Trials
Industry	25
Other	6

Differin Market Analysis and Financial Projection

Clinical Trials, Market Analysis, and Projections for DIFFERIN (Adapalene)

Clinical Trials Overview

DIFFERIN, a topical retinoid containing adapalene, has undergone extensive clinical trials to establish its efficacy and safety in treating acne and other dermatological conditions.

Efficacy in Acne Treatment

In a 12-week clinical trial, DIFFERIN Gel, 0.3% and 0.1%, was applied to the face and optionally to the trunk of patients with moderate to moderately severe acne. The results showed significant reductions in both inflammatory and non-inflammatory acne lesions. For the 0.3% gel, the mean absolute reduction in inflammatory lesions was 14.4 (51.6% reduction), and for non-inflammatory lesions, it was 16.3 (39.7% reduction)[1][4].

Safety Profile

A one-year, open-label safety trial involving 551 subjects with acne who received DIFFERIN Gel, 0.3%, revealed a pattern of adverse reactions similar to those observed in shorter-term studies. Common local cutaneous irritations included erythema, scaling, dryness, and burning/stinging, with most reactions being mild or moderate[1][4].

Pharmacokinetics

Studies have shown that adapalene is rapidly cleared from plasma, with concentrations below the limit of detection 72 hours after the last application. The drug is primarily excreted via the biliary route, and systemic exposure is minimal[1][4].

Market Analysis

Market Size and Growth

The adapalene drugs market, which includes DIFFERIN, is experiencing significant growth driven by increasing incidences of skin disorders, rising awareness about skincare, and advancements in drug formulations. The global adapalene market is projected to expand at a considerable CAGR from 2024 to 2029, with the market size expected to increase substantially during this period[2][5].

Market Drivers

Key factors driving the growth of the adapalene market include:

• Growing Prevalence of Acne: Especially among adolescent and adult populations, which increases the demand for effective acne treatments.
• Expanding Product Lines: Introduction of various formulations such as creams, gels, and lotions.
• E-commerce Platforms: Widespread distribution and visibility of adapalene products through online channels.
• Professional Skincare Services: Expansion in dermatology clinics and professional skincare services amplifies prescriptions and recommendations for adapalene products[2].

Market Opportunities

• Targeting Aging Populations: Adapalene products are being explored for their potential anti-aging effects, such as reducing wrinkles and fine lines.
• Emerging Markets: Increasing consumer awareness about skincare in urban populations worldwide presents opportunities for market expansion.
• Digital Marketing: Enhancing digital marketing efforts to reach skin-conscious consumers can further boost market demand[2].

Market Challenges and Restraints

Supply Chain Disruptions

Supply chain disruptions can affect the availability of key components for adapalene drugs, posing a challenge to market growth.

• Healthcare Provider Trust: Building trust among healthcare providers in prescribing adapalene drugs amid increasing product criticisms is crucial[2].

Regulatory Approvals

Obtaining regulatory approvals for new uses of adapalene and navigating the complex regulatory landscape can be challenging but also presents opportunities for market expansion[2].

Competitive Landscape

Porter’s Five Forces Analysis

The Porter’s Five Forces analysis helps in understanding the competitive position of businesses in the adapalene drugs market. This includes analyzing the threat of new entrants, bargaining power of suppliers, bargaining power of buyers, threat of substitute products, and the intensity of competitive rivalry. This analysis is essential for companies to strategize and position themselves effectively in the market[2].

FPNV Positioning Matrix

The FPNV positioning matrix evaluates the market positioning of vendors based on critical metrics related to business strategy and product satisfaction. This matrix categorizes vendors into four quadrants: Forefront, Pathfinder, Niche, or Vital, helping users make informed decisions[2].

Strategy Analysis and Recommendations

Market Penetration and Development

Companies should focus on expanding their product lines and increasing penetration in emerging markets where skincare awareness is rising. Strategic partnerships with dermatologists and enhancing digital marketing efforts are recommended to reach a broader consumer base[2].

Product Development and Innovation

Investing in research and development to introduce new formulations and improve existing products can help companies stay competitive. Notable advancements in product innovation, such as exploring adapalene’s potential in treating other dermatological disorders, can also drive market growth[2].

Key Takeaways

• Clinical Efficacy: DIFFERIN has demonstrated significant efficacy in reducing acne lesions and improving skin condition.
• Market Growth: The adapalene market is expected to grow substantially due to increasing demand for skincare products and expanding product lines.
• Challenges: Supply chain disruptions, healthcare provider trust, and regulatory approvals are key challenges that need to be addressed.
• Opportunities: Targeting aging populations, emerging markets, and digital marketing are significant opportunities for market expansion.

Frequently Asked Questions (FAQs)

1. What is the primary use of DIFFERIN (adapalene)?

DIFFERIN (adapalene) is primarily used as a topical treatment for acne vulgaris.

2. What are the common side effects of DIFFERIN Gel?

Common side effects include local cutaneous irritations such as erythema, scaling, dryness, and burning/stinging[1][4].

3. How is adapalene metabolized and excreted?

Adapalene is rapidly cleared from plasma and primarily excreted via the biliary route[1][4].

4. What are the key drivers of the adapalene market growth?

Key drivers include the growing prevalence of acne, expanding product lines, e-commerce platforms, and professional skincare services[2].

5. What are the potential new uses of adapalene being explored?

Adapalene is being explored for its potential anti-aging effects, such as reducing wrinkles and fine lines, and treating other dermatological disorders[2].

Cited Sources:

1. DIFFERIN Gel Label - FDA.
2. Adapalene Drugs Market Size & Share 2025-2030 - 360iResearch.
3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033 - BioSpace.
4. Differin (adapalene) gel label - FDA.
5. Adapalene Market Size, Share, Trend and Forecast to 2025 - Prof Research.