Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne

Study Overview
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Brief Summary
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evaluate the safety and efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in treatment of chinese patients with acne.

Official Title
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A Placebo Control, Multicenter, Randomized, Double Blind, Multi-formula Groups, and Parallel Phase Ⅰb+Ⅱa Study Evaluating the Safety and Efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne

Conditions
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Acne

Intervention / Treatment
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* Drug: Adapalene + Clindamycin Hydrochloride
* Drug: Adapalene + Clindamycin Hydrochloride
* Drug: Adapalene + Clindamycin Hydrochloride
* Drug: Adapalene + Clindamycin Hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18 to 40 years old, female or male; Class I-III of Acne vulgaris according to the International Modified PILLSBURY Classification; Patients voluntarily take part in the study and sign the ICF. Exclusion Criteria: The subject is known to be allergic to adapalene, clindamycin hydrochloride, clindamycin, and / or any components of gel excipient; Patients with secondary acne including occupational acne and corticosteroid-induced acne; The affected skin has other concomitant lesion (such as solar dermatitis, psoriasis, seborrheic dermatitis, eczema and extremely severe acne) which may impact the efficacy evaluation; Subject has the history of regional enteritis, ulcerative colitis or antibiotic-associated colitis; Patient has history of severe cardiac disease and hypertension; Patient has severe liver and kidney diseases with AST/ALT more than twice upper limitation, or Cr, total cholesterol and triglycerides above normal range; Patients with severe endocrine diseases, blood diseases, and neuropsychiatric disorders; Patients are known to have severe immune dysfunction, or need long-term use of corticosteroids or immunosuppressive agents; Pregnant or breastfeeding women, or unwilling to take effective contraceptive measures during the study; Alcoholic patients or drug abusers; Patient has used other acne drugs topically within 2 weeks before the study start; Patient has been administered with victoria A acid, vitamins, and antibiotics within 4 weeks before the study start; Patient has participated in other study within 3 months before the study start; The subject is not fit to take part in this study in the judgment of the investigator.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treat group 1<br>Group 1: 0.1% Adapalene + 1% Clindamycin Hydrochloride | Drug: Adapalene + Clindamycin Hydrochloride<br>* 0.1% Adapalene + 1% Clindamycin Hydrochloride<br>|
| Experimental: Treatment group 2<br>Group 2: 0.1% Adapalene + 2% Clindamycin Hydrochloride | Drug: Adapalene + Clindamycin Hydrochloride<br>* 0.1% Adapalene + 2% Clindamycin Hydrochloride<br>|
| Experimental: Treatment group 3<br>Group 3: 0.05% Adapalene + 0.5% Clindamycin Hydrochloride | Drug: Adapalene + Clindamycin Hydrochloride<br>* 0.05% Adapalene + 0.5% Clindamycin Hydrochloride<br>|
| Experimental: Treatment group 4<br>Group 4: 0.05% Adapalene + 1% Clindamycin Hydrochloride | Drug: Adapalene + Clindamycin Hydrochloride<br>* 0.05% Adapalene + 1% Clindamycin Hydrochloride<br>|
| Placebo Comparator: Placebo group<br>Placebo Group: Blank Gel | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy endpoint | number of patients with deceased acne lesions at the treatment end (Day 85±3) in each group; | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGA classification change | The improvement of IGA （investigator general Assess）Classification at the treatment end (Day 85±3) in each group | 12 weeks | 
| treatment success rate | The treatment success rate at the treatment end (Day 85±3) in each group; calculation methods:number of patients with IGA assessment improved to level 0 to level 1/ total number of patients | 12 weeks | 
| PK | AUC | 12 weeks | 
| PK | peak plasma concentration | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, efficacy