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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Combination Product: Adapalene-Clindamycin Combination Gel
* Drug: Adapalene Gel
* Drug: Clindamycin Gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adapalene-Clindamycin Combination Gel<br> | Combination Product: Adapalene-Clindamycin Combination Gel<br>* 5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks<br>|
| Active Comparator: Adapalene Gel<br> | Drug: Adapalene Gel<br>* Differin 0.1% Gel, applied nightly for 12 weeks<br>* Other names: Differin;|
| Active Comparator: Clindamycin Gel<br> | Drug: Clindamycin Gel<br>* Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks<br>* Other names: Clindamycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline in Total Lesion Counts | Percent change from Baseline in total lesions counts in each treatment group at Week 12. | Week 12 | 
| Proportion of patients who has at least a two-point reduction in Investigator Global Assessment (IGA) compared to baseline |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from baseline in inflammatory lesion counts | Percent change from baseline in inflammatory lesions count in each treatment group at Week 12. | Week 12 | 
| Percentage change from baseline in non-inflammatory lesion counts | Percent change from baseline in non-inflammatory lesions count in each treatment group at Week 12. | Week 12 | 
| Change from baseline in inflammatory lesion counts | Absolute change from baseline in inflammatory lesion counts in each treatment group at Week 12. | Week 12 | 
| Change from baseline in non-inflammatory lesion counts | Absolute change from baseline in non-inflammatory lesion counts in each treatment group at Week 12. | Week 12 | 
| Change from baseline in total lesion counts | Absolute change from baseline in total lesions counts in each treatment group at Week 12. | Week 12 | 
| Change from baseline in Investigator's Global Assessment (IGA) | Absolute change from baseline in Investigator's Global Assessment (IGA) in each treatment group at Week 12. | Week 12 | 
| Treatment success rate | 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. | Week 12 |