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

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

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

Inclusion Criteria:

1. Age from 18 to 40 years old, female or male;
2. Class I-III of Acne vulgaris according to the International Modified PILLSBURY Classification;
3. Patients voluntarily take part in the study and sign the ICF.

Exclusion Criteria:

1. The subject is known to be allergic to adapalene, clindamycin hydrochloride, clindamycin, and / or any components of gel excipient;
2. Patients with secondary acne including occupational acne and corticosteroid-induced acne;
3. 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;
4. Subject has the history of regional enteritis, ulcerative colitis or antibiotic-associated colitis;
5. Patient has history of severe cardiac disease and hypertension;
6. Patient has severe liver and kidney diseases with AST/ALT more than twice upper limitation, or Cr, total cholesterol and triglycerides above normal range;
7. Patients with severe endocrine diseases, blood diseases, and neuropsychiatric disorders;
8. Patients are known to have severe immune dysfunction, or need long-term use of corticosteroids or immunosuppressive agents;
9. Pregnant or breastfeeding women, or unwilling to take effective contraceptive measures during the study;
10. Alcoholic patients or drug abusers;
11. Patient has used other acne drugs topically within 2 weeks before the study start;
12. Patient has been administered with victoria A acid, vitamins, and antibiotics within 4 weeks before the study start;
13. Patient has participated in other study within 3 months before the study start;
14. The subject is not fit to take part in this study in the judgment of the investigator.