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

Phase 1

Completed

• Conditions: Acne
• Interventions: Drug: Adapalene + Clindamycin Hydrochloride; Drug: Placebo

• Registration Number: NCT02593383
• Lead Sponsor: Lee's Pharmaceutical Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-01
• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-01
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group 4	Adapalene + Clindamycin Hydrochloride	Group 4: 0.05% Adapalene + 1% Clindamycin Hydrochloride
Treatment group 2	Adapalene + Clindamycin Hydrochloride	Group 2: 0.1% Adapalene + 2% Clindamycin Hydrochloride
Treat group 1	Adapalene + Clindamycin Hydrochloride	Group 1: 0.1% Adapalene + 1% Clindamycin Hydrochloride
Treatment group 3	Adapalene + Clindamycin Hydrochloride	Group 3: 0.05% Adapalene + 0.5% Clindamycin Hydrochloride
Placebo group	Placebo	Placebo Group: Blank Gel

Primary Outcome Measures

Name	Time	Method
efficacy endpoint	12 weeks	number of patients with deceased acne lesions at the treatment end (Day 85±3) in each group;

Secondary Outcome Measures

Name	Time	Method
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	peak plasma concentration
IGA classification change	12 weeks	The improvement of IGA （investigator general Assess）Classification at the treatment end (Day 85±3) in each group

Trial Locations

Locations (1)

Institute of Dermatology, Chinese Academy of Medical Sciences; 🇨🇳 Nanjing, Jiangsu, China