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

Acne Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593383
• Other study ID #: zhaoke-2015-02
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

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