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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02593383
Other study ID # zhaoke-2015-02
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date March 1, 2015
Est. completion date July 31, 2017

Study information

Verified date September 2019
Source Lee's Pharmaceutical Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 245
Est. completion date July 31, 2017
Est. primary completion date July 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 1% Clindamycin Hydrochloride
Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 2% Clindamycin Hydrochloride
Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 0.5% Clindamycin Hydrochloride
Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 1% Clindamycin Hydrochloride
Placebo


Locations

Country Name City State
China Institute of Dermatology, Chinese Academy of Medical Sciences Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Lee's Pharmaceutical Limited

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary efficacy endpoint number of patients with deceased acne lesions at the treatment end (Day 85±3) in each group; 12 weeks
Secondary IGA classification change The improvement of IGA (investigator general Assess)Classification at the treatment end (Day 85±3) in each group 12 weeks
Secondary treatment success rate 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 12 weeks
Secondary PK AUC 12 weeks
Secondary PK peak plasma concentration 12 weeks
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