Clinical trial NCT02593383: Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acne
Keywords: safety
efficacy
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2015-11-01
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: efficacy endpoint
timeFrame: 12 weeks
Secondary outcomes:
measure: IGA classification change
timeFrame: 12 weeks
measure: treatment success rate
timeFrame: 12 weeks
measure: PK
timeFrame: 12 weeks
measure: PK
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Institute of Dermatology, Chinese Academy of Medical Sciences
state: Jiangsu
Study officials:
affiliation: Institute of Dermatology, Chinese Academy of Medical Sciences
name: Heng GU, MD
role: PRINCIPAL_INVESTIGATOR
References: