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

Lee's Pharmaceutical

Status and phase

Completed

Phase 2

Phase 1

Conditions

Acne

Treatments

Drug: Placebo

Drug: Adapalene + Clindamycin Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT02593383

zhaoke-2015-02

Details and patient eligibility

About

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

Enrollment

245 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age from 18 to 40 years old, female or male;
Class I-III of Acne vulgaris according to the International Modified PILLSBURY Classification;
Patients voluntarily take part in the study and sign the ICF.

Exclusion criteria

The subject is known to be allergic to adapalene, clindamycin hydrochloride, clindamycin, and / or any components of gel excipient;
Patients with secondary acne including occupational acne and corticosteroid-induced acne;
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;
Subject has the history of regional enteritis, ulcerative colitis or antibiotic-associated colitis;
Patient has history of severe cardiac disease and hypertension;
Patient has severe liver and kidney diseases with AST/ALT more than twice upper limitation, or Cr, total cholesterol and triglycerides above normal range;
Patients with severe endocrine diseases, blood diseases, and neuropsychiatric disorders;
Patients are known to have severe immune dysfunction, or need long-term use of corticosteroids or immunosuppressive agents;
Pregnant or breastfeeding women, or unwilling to take effective contraceptive measures during the study;
Alcoholic patients or drug abusers;
Patient has used other acne drugs topically within 2 weeks before the study start;
Patient has been administered with victoria A acid, vitamins, and antibiotics within 4 weeks before the study start;
Patient has participated in other study within 3 months before the study start;
The subject is not fit to take part in this study in the judgment of the investigator.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

245 participants in 5 patient groups, including a placebo group

Treat group 1

Experimental group

Description:

Group 1: 0.1% Adapalene + 1% Clindamycin Hydrochloride

Treatment:

Drug: Adapalene + Clindamycin Hydrochloride

Treatment group 2

Experimental group

Description:

Group 2: 0.1% Adapalene + 2% Clindamycin Hydrochloride

Treatment:

Drug: Adapalene + Clindamycin Hydrochloride

Treatment group 3

Experimental group

Description:

Group 3: 0.05% Adapalene + 0.5% Clindamycin Hydrochloride

Treatment:

Drug: Adapalene + Clindamycin Hydrochloride

Treatment group 4

Experimental group

Description:

Group 4: 0.05% Adapalene + 1% Clindamycin Hydrochloride

Treatment:

Drug: Adapalene + Clindamycin Hydrochloride

Placebo group

Placebo Comparator group

Description:

Placebo Group: Blank Gel

Treatment:

Drug: Placebo

Trial contacts and locations

1

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