Last Updated: May 10, 2026

CLINICAL TRIALS PROFILE FOR DIFFERIN


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for DIFFERIN

Condition Name

Condition Name for DIFFERIN
Intervention Trials
Acne Vulgaris 16
Skin Manifestations 2
Acne Papulopustulosa 1
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Condition MeSH

Condition MeSH for DIFFERIN
Intervention Trials
Acne Vulgaris 18
Skin Manifestations 2
[disabled in preview] 1
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Clinical Trial Locations for DIFFERIN

Trials by Country

Trials by Country for DIFFERIN
Location Trials
United States 42
Germany 2
Belize 2
Singapore 1
China 1
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Trials by US State

Trials by US State for DIFFERIN
Location Trials
North Carolina 5
Texas 5
California 4
Florida 3
Ohio 3
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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
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Clinical Trial Status

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Withdrawn 2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

Sponsor Name

Sponsor Name for DIFFERIN
Sponsor Trials
Galderma Laboratories, L.P. 5
Galderma 2
Galderma R&D 2
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Sponsor Type

Sponsor Type for DIFFERIN
Sponsor Trials
Industry 25
Other 6
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DIFFERIN (adapalene): Clinical Trials Update, Market Analysis, and Projection

Last updated: April 25, 2026

What is DIFFERIN and what product scope matters for market sizing?

DIFFERIN is the brand name for adapalene, a topical retinoid used primarily for acne vulgaris. Differentiation for market analytics depends on the formulation and strength because sales channels, pricing, and substitution patterns differ by gel vs cream and by concentration.

Typical DIFFERIN presentations used in major markets

  • DIFFERIN Gel 0.1% (adapalene topical)
  • DIFFERIN Cream 0.1% (where marketed)
  • In some markets or channels, adapalene is also sold as generic adapalene 0.1% (often via pharmacy substitution and low-switch-cost dispensing)

Clinical development relevance

  • Adapalene has long product history, but ongoing clinical trials typically focus on:
    • new delivery/combinations,
    • safety/efficacy in specific subpopulations (age, skin types, comedonal vs inflammatory acne),
    • comparative effectiveness versus other OTC or prescription acne actives,
    • regimen optimization (vehicle, frequency, adjuncts).

What does the latest clinical trials activity show for adapalene/DIFFERIN?

No complete, verifiable “latest” clinical trial dataset was provided in the prompt, and producing an accurate update requires a source-linked inventory of active and recently completed studies (e.g., ClinicalTrials.gov/NLM entries with dates, statuses, endpoints, and results). Under the operating constraints, a complete and accurate response cannot be generated without that trial record.

How is the acne topical market structured, and where does DIFFERIN fit?

Acne therapeutics are a mature category with frequent generic entry for older topical actives. Competitive intensity is driven by:

  • OTC availability for some actives (depending on market),
  • generic erosion of prescription retinoids once exclusivity lapses,
  • channel power of large pharmacy chains and formularies,
  • physician preference for tolerability and consistent irritation profiles.

Key competitors and substitute classes

  • Other topical retinoids (brand and generic; strength, vehicle, and irritation profile drive switching)
  • Topical antibiotics (where used, often limited by resistance and prescribing controls)
  • Benzoyl peroxide combinations
  • Fixed-dose combinations (retinoid + antimicrobial or retinoid + benzoyl peroxide where formulations exist)
  • Newer topical modalities in some geographies (less frequent for straight adapalene brand capture but relevant for share substitution)

Positioning of adapalene

  • Retinoids remain cornerstone for acne maintenance due to comedolytic activity.
  • Adapalene’s differentiation is typically anchored on tolerability and daily-use regimen behavior rather than unique MOA for the class.

What drives DIFFERIN pricing, share, and margin?

DIFFERIN’s market performance is determined by three forces:

  1. Generic pressure

    • Adapalene 0.1% is widely generic.
    • Brand differentiation must persist via clinic/retail preference, patient adherence, and rebate/formulary contracts.
  2. Formulary and channel strategy

    • Many markets rely on pharmacy substitution and category basket economics.
    • Where branded price premiums are accepted, they are often tied to adherence or physician brand preference rather than clinical superiority claims.
  3. Safety perception and adherence

    • Topical retinoid irritation management drives discontinuation rates.
    • Formulation vehicle and patient education are commercial levers because acne therapy failure is often adherence-driven.

Market analysis: how to project DIFFERIN sales in a generic-heavy category

A robust projection needs market-size baselines, current revenue, unit volumes, and forecast assumptions by formulation and geography. The prompt does not include current sales, country splits, or adoption metrics, and the response must remain complete and accurate. Under the operating constraints, numerical projection cannot be produced.

What forecast framework is appropriate (without inventing numbers)?

A defensible forecast for a mature generic-exposed topical acne asset uses a 3-layer model:

  • Category growth: acne prevalence and treatment penetration shift (usually modest in mature markets).
  • Share drift:
    • generic substitution rate changes,
    • repurchase cycle length,
    • physician prescribing behavior,
    • OTC encroachment (where relevant).
  • Price/mix:
    • net price declines versus generics,
    • formulation mix (gel vs cream),
    • contract rebates and channel promotions.

For DIFFERIN specifically, share erosion and price compression typically dominate over category growth in long-run projections unless there is a formulation relaunch with distinct differentiation or combination expansion.

Clinical development and pipeline interpretation for an established topical retinoid

Since adapalene is mature, pipeline value often comes from:

  • combination products (retinoid + complementary active),
  • vehicle optimization,
  • adherence-driven regimen changes (frequency, tolerability),
  • label expansions in younger age bands or specific acne severities where regulators accept supportive clinical data.

A clinical trials update for DIFFERIN would normally be judged by:

  • number of active registrational or supportive trials,
  • endpoints (IGA success, inflammatory lesion counts, comedonal response, time-to-improvement),
  • safety signals (irritation rates, discontinuation),
  • whether studies are designed for label expansion vs lifecycle management.

Key market and clinical decision points for investors and R&D

Without verified trial and sales inputs, the actionable “decision points” are still clear at the level of commercial mechanics:

  • If trials are primarily comparative or supportive, they likely protect label usage and sustain differentiation versus generics.
  • If trials are combination-focused, they can reset competitive positioning and support higher net pricing (if payers/physicians perceive additional benefit).
  • If trials are small or non-registrational, they typically improve stewardship and marketing claims rather than create new growth drivers.

Key Takeaways

  • DIFFERIN is a long-established topical acne brand based on adapalene 0.1%, in a market where generic substitution and channel pricing dominate outcomes.
  • A complete “latest clinical trials update” and quantified market projection require a source-linked trial inventory and current revenue/unit baselines; these were not provided in the prompt, so no fabricated trial or forecast numbers are included.
  • For projection modeling, the correct drivers are category growth, share drift under generic erosion, and net price/mix by formulation and geography.
  • The most investable clinical activity for mature topical retinoids typically centers on combination products and tolerability/adherence differentiation that can withstand generic substitution.

FAQs

  1. Is DIFFERIN still affected by generic competition?
    Yes. Adapalene topical 0.1% is widely available as generics, which pressures brand net price and share.

  2. What is the primary indication for DIFFERIN?
    Acne vulgaris, typically across mild to moderate presentations depending on local labeling.

  3. What types of clinical trials matter most for an established topical retinoid?
    Label-supportive studies, tolerability and regimen optimization, and combination or vehicle approaches that can sustain differentiation.

  4. What determines market share for topical acne brands?
    Prescribing behavior, pharmacy substitution dynamics, formulary/rebate economics, and patient adherence driven by irritation tolerance.

  5. How should projections be built for a mature generic-exposed topical product?
    Use a model that separates category growth, market-share drift under generic penetration, and net price/mix effects.


References

[1] FDA. DIFFERIN (adapalene) prescribing information (label).
[2] NLM/ClinicalTrials.gov. Clinical trials database records for adapalene and related topical retinoid studies.
[3] GlobalData/IMS-style market reporting (category acne topical market datasets where available).

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