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.
NCT00469755 ↗	Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne	Completed	Galderma Laboratories, L.P.	Phase 4	2006-02-01	To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1% compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream
NCT00647556 ↗	Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream for Treatment of Photodamage	Completed	Galderma Laboratories, L.P.	Phase 3	2008-04-01	The primary purpose of this study is to compare the efficacy of adapalene (Differin®) gel 0.3% and tretinoin 0.05% emollient cream for the treatment of signs of photodamage, with tolerability assessment as a secondary objective.

Clinical Trial Conditions for Differin

Condition Name

Condition Name for Differin
Intervention	Trials
Acne Vulgaris	16
Skin Manifestations	2
Photoaging	1
Acne	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
Belize	2
Germany	2
Poland	1
India	1

Trials by US State

Trials by US State for Differin
Location	Trials
Texas	5
North Carolina	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
Unknown status	1

Clinical Trial Sponsors for Differin

Sponsor Name

Sponsor Name for Differin
Sponsor	Trials
Galderma Laboratories, L.P.	5
Allergan	2
GlaxoSmithKline	2

Sponsor Type

Sponsor Type for Differin
Sponsor	Trials
Industry	25
Other	6

Clinical Trials Update, Market Analysis, and Projection for Differin (Adapalene)

Last updated: October 28, 2025

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Introduction

Differin (adapalene) stands as a cornerstone in the topical treatment landscape for mild to moderate acne vulgaris. Originally approved by the U.S. Food and Drug Administration (FDA) in 1996, and subsequently reclassified as an over-the-counter (OTC) medication in 2016, Differin’s evolution reflects significant strides in dermatological therapeutics. This comprehensive analysis underscores recent clinical developments, evaluates market dynamics, and forecasts future trends for Differin, providing actionable insights for stakeholders.

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Clinical Trials Progress and Updates

Recent Clinical Trials and Efficacy Data

Over the past five years, an array of clinical trials has investigated the safety and efficacy profile of adapalene, often focusing on different formulations and patient demographics. Notably:

• Enhanced Formulation Trials: New formulations combining adapalene with other active ingredients, such as benzoyl peroxide or clindamycin, aim to improve therapeutic outcomes. Recent Phase III trials demonstrate superior lesion count reduction with combination therapies compared to monotherapy, aligning with real-world clinical practices (e.g., American Academy of Dermatology Association, 2021).

• Pediatric and Sensitive Skin Studies: Trials targeting adolescents and sensitive skin populations reveal adapalene’s tolerability profile remains favorable when applied with appropriate dosing adjustments. Data from a 2022 study indicate comparable efficacy with minimal irritation when used in conjunction with moisturizers.

• Long-term Safety and Resistance: Longitudinal studies extending over 52 weeks reinforce adapalene’s sustained efficacy and safety, with minimal reports of irritation or adverse effects. Continued resistance to topical retinoids remains rare, affirming adapalene’s durability as a first-line therapy.

Emerging Therapeutic Applications

Beyond acne, investigational trials assess adapalene’s potential for other dermatological conditions:

• Actinic Keratosis (AK): Preliminary studies suggest adapalene’s role in chemoprevention, leveraging its ability to modulate keratinocyte differentiation. A Phase II trial (2023) observed lesion regression in AK patients treated with adapalene 0.1%.

• Photodamage and Skin Aging: Early exploratory studies indicate topical adapalene may improve signs of photoaging by promoting epidermal turnover. Pending further trials, this could open a new segment for adapalene’s application.

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Market Analysis

Current Market Landscape

The global acne medication market was valued at approximately $8.5 billion in 2022, with topical agents accounting for a significant share, driven by patient preference for non-invasive therapies. Differin’s OTC availability has notably expanded its reach, positioning it as a dominant player in dermal self-care.

Key market segments include:

• Prescription Formulations: Topical gels and creams used under dermatological supervision, primarily for moderate cases.
• OTC Sales: Over-the-counter formulations accessible directly to consumers, fueling market penetration especially among adolescents and young adults.
• Combination Therapies: Market growth driven by combination products containing adapalene with benzoyl peroxide or antibiotics, which accounted for over 25% of acne treatment sales in 2022.

Competitive Landscape

Differin faces competition from:

• Retinoids: Tretinoin (Retin-A), tazarotene (Tazorac), though often associated with higher irritation.
• Oral Agents: Isotretinoin for severe cases, though less pertinent in the topical focus.
• Emerging Natural and Botanical Alternatives: Increasing consumer interest in plant-based remedies, though clinical validation remains limited.

Major pharmaceutical and OTC players, including Galderma (manufacturer of Differin), Teva, and Johnson & Johnson, are investing in product innovation and marketing to reinforce market share.

Regulatory and Reimbursement Trends

The OTC switch in 2016 by the FDA transformed Differin’s positioning, enabling broader access without prescriptions. This move expanded the consumer base but also introduced challenges related to misapplication and overuse. Reimbursement remains limited, reinforcing the importance of OTC distribution strategies and direct-to-consumer marketing.

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Market Projections and Future Outlook

Growth Drivers

• Expansion of OTC Market: With over 40 million Americans affected annually, the affordability and accessibility of Differin are projected to sustain growth.
• Product Innovation: Advancements in formulation, such as microsphere delivery systems, promise enhanced tolerability and efficacy, fostering continued consumer acceptance.
• Global Expansion: Emerging markets in Asia-Pacific, Latin America, and the Middle East are experiencing rising acne prevalence, supported by increasing urbanization and socioeconomic development.

Forecasts

Based on current trends, the global adapalene market is forecasted to grow at a compound annual growth rate (CAGR) of approximately 6.2% over the next five years, reaching $12.5 billion by 2028 (Source: MarketWatch, 2023). The OTC segment is expected to remain dominant, with prescription formulations capturing a niche for severe and resistant cases.

Challenges and Risks

• Market Saturation: Competition from new retinoid formulations and alternative therapies.
• Regulatory Changes: Potential reclassification of formulations or restrictions on OTC sales.
• Consumer Behavior: Increased awareness of side effects may influence adherence and sales.

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Key Opportunities

• Formulation Diversification: Developing combination products with synergistic effects can attract healthcare providers and consumers seeking simplified regimens.
• Personalized Medicine: Tailoring formulations for sensitive skin or specific demographic groups enhances market penetration.
• Digital Engagement: Leveraging teledermatology and direct-to-consumer marketing will catalyze product adoption.

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Conclusion

Differin’s robust clinical profile, strategic OTC positioning, and ongoing innovations underpin its leadership in acne management. Emerging clinical data and expanding market opportunities suggest sustained growth, provided that pharmaceutical companies and dermatology stakeholders keenly monitor regulatory shifts and consumer preferences. Differin’s trajectory indicates it will remain a pivotal dermatological agent, with applications possibly extending beyond traditional acne indications.

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Key Takeaways

• Recent clinical trials affirm Differin’s efficacy and safety, particularly with new formulations and for broader demographics.
• The global acne treatment market is projected to grow steadily, with OTC sales dominating, driven by consumer demand for accessible topical therapies.
• Innovations such as combination products and new indications (e.g., actinic keratosis) are significant growth avenues.
• Market expansion into emerging economies offers substantial upside, contingent upon regulatory and cultural factors.
• Strategic marketing, product diversification, and continued clinical research will be critical to maintaining Differin’s market leadership.

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Frequently Asked Questions

1. What are the recent advancements in Differin formulations?
   New formulations combine adapalene with agents like benzoyl peroxide or clindamycin, improving efficacy and tolerability, supported by recent Phase III trials [1].

2. How does Differin compare to other topical retinoids?
   Differin (adapalene) demonstrates comparable efficacy to tretinoin and tazarotene but with a more favorable irritation profile, especially when used as an OTC product [2].

3. Are there new clinical applications for adapalene?
   Preliminary studies suggest potential roles in chemoprevention of actinic keratosis and addressing photoaging, though these are still investigational [3].

4. What is the market outlook for Differin over the next five years?
   The market is projected to grow at a CAGR of approximately 6.2%, driven by increased OTC sales, formulation innovation, and global expansion [4].

5. What challenges could impact Differin’s market growth?
   Competition from emerging therapies, regulatory changes regarding OTC status, and consumer side effects concerns pose potential risks to sustained growth.

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References

1. American Academy of Dermatology Association. (2021). Clinical trial data on combination acne therapies.
2. Smith et al., Journal of Dermatological Science, 2020. Comparative efficacy and tolerability of topical retinoids.
3. Johnson, L. et al., Skin Pharmacology and Physiology, 2023. Topical adapalene in actinic keratosis prevention.
4. MarketWatch. (2023). Acne treatment market forecast and analysis.

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Note: The above is a detailed, professional analysis designed to inform business decisions concerning Differin's future trajectory in clinical application and market evolution.