Acne
Conditions
Keywords
safety, efficacy
Brief summary
evaluate the safety and efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in treatment of chinese patients with acne.
Interventions
DRUGAdapalene + Clindamycin Hydrochloride
0.1% Adapalene + 1% Clindamycin Hydrochloride
DRUGPlacebo
Sponsors
Lee's Pharmaceutical Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy endpoint | 12 weeks | number of patients with deceased acne lesions at the treatment end (Day 85±3) in each group; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IGA classification change | 12 weeks | The improvement of IGA （investigator general Assess）Classification at the treatment end (Day 85±3) in each group |
| treatment success rate | 12 weeks | 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 |
| PK | 12 weeks | AUC |
Countries
China
Outcome results
None listed