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Completed

NCT Number: NCT03615768

A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences

Nanjing, Jiangsu, 210042, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, aged 12-40 years old
  • Diagnosis of Grade II-III acne vulgaris with Pillsbury grading system
  • Provide written informed consent if the subject is aged 18 or older. Ages 12-17 should provide written assent and written informed consent from patient's parent or legal guardian.

Exclusion criteria

  • Known hypersensitivity to adapalene, clindamycin hydrochloride, clindamycin phosphate, lincomycin or any ingredient of the study drug, or of allergic constitution
  • Secondary Acne, such as occupational acne and steroid acne
  • Has a dermatological condition of the face that could interfere with the clinical evaluations, such as sunburn, psoriasis, seborrheic dermatitis or eczema
  • History of Crohn's disease, ulcerative colitis or antibiotic-associated colitis
  • History of serious heart disease or hypertension
  • Serious liver or kidney disease, AST or ALT more than twice the upper limit of normal, or Cr above normal
  • Serious endocrine, hematologic or psychiatric disease
  • Known immunocompromised conditions, or require long-term steroids or immunosuppressants
  • Females who are pregnant, lactating, or not willing to use effective contraception
  • Drug or alcohol abuse
  • Used any topical acne treatment within 2 weeks
  • Used any systemic retinoid, antibiotic or other acne treatment
  • Used any investigational drugs or device within 3 months, or concurrently enrolled in another clinical trial
  • Patient who the investigator deemed to be unsuitable for any reason

Treatment and study plan

Adapalene-Clindamycin Combination Gel

Combination Product

5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks

Adapalene Gel

Drug

Differin 0.1% Gel, applied nightly for 12 weeks

Other names: Differin

Clindamycin gel

Drug

Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks

Other names: Clindamycin

Primary outcomes

  1. Percentage Change From Baseline in Total Lesion Counts

    Time frame: Week 12

    Percent change from Baseline in total lesions counts in each treatment group at Week 12.

  2. Proportion of patients who has at least a two-point reduction in Investigator Global Assessment (IGA) compared to baseline

    Time frame: Week 12

Secondary outcomes

  1. Percentage change from baseline in inflammatory lesion counts

    Time frame: Week 12

    Percent change from baseline in inflammatory lesions count in each treatment group at Week 12.

  2. Percentage change from baseline in non-inflammatory lesion counts

    Time frame: Week 12

    Percent change from baseline in non-inflammatory lesions count in each treatment group at Week 12.

  3. Change from baseline in inflammatory lesion counts

    Time frame: Week 12

    Absolute change from baseline in inflammatory lesion counts in each treatment group at Week 12.

  4. Change from baseline in non-inflammatory lesion counts

    Time frame: Week 12

    Absolute change from baseline in non-inflammatory lesion counts in each treatment group at Week 12.

  5. Change from baseline in total lesion counts

    Time frame: Week 12

    Absolute change from baseline in total lesions counts in each treatment group at Week 12.

  6. Change from baseline in Investigator's Global Assessment (IGA)

    Time frame: Week 12

    Absolute change from baseline in Investigator's Global Assessment (IGA) in each treatment group at Week 12.

  7. Treatment success rate

    Time frame: Week 12

    The proportion of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)"; if IGA score at baseline is 2, success is only achieved if IGA score is 0 at Week 12.

Other outcomes

  1. Local Adverse Reactions

    Time frame: Week 2, Week 4, Week 8 and Week 12

    Local Adverse Reactions including erythema, scaling, stinging, burning and pruritus scored by severity

Sponsors and collaborators

Lead sponsor

Lee's Pharmaceutical Limited

Industry

Collaborators

  • Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Registry information

Official study title

A Multi-center, Randomized, Single-blind, Paralelle, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Moderate Acne Vulgaris

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2018
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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