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

• Status: Completed
• Trial end date: 2017-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lee's Pharmaceutical Limited
• Treatments: Adapalene; Clindamycin; Clindamycin palmitate; Clindamycin phosphate

Criteria

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.