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

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

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

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Drug: Placebo; Drug: Adapalene + Clindamycin Hydrochloride; Drug: Adapalene + Clindamycin Hydrochloride; Drug: Adapalene + Clindamycin Hydrochloride; Drug: Adapalene + Clindamycin Hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210042
      • Institute of Dermatology, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treat group 1; Group 1: 0.1% Adapalene + 1% Clindamycin Hydrochloride	Drug: Adapalene + Clindamycin Hydrochloride; 0.1% Adapalene + 1% Clindamycin Hydrochloride; Drug: Adapalene + Clindamycin Hydrochloride; 0.1% Adapalene + 2% Clindamycin Hydrochloride; Drug: Adapalene + Clindamycin Hydrochloride; 0.05% Adapalene + 0.5% Clindamycin Hydrochloride; Drug: Adapalene + Clindamycin Hydrochloride; 0.05% Adapalene + 1% Clindamycin Hydrochloride
Experimental: Treatment group 2; Group 2: 0.1% Adapalene + 2% Clindamycin Hydrochloride	Drug: Adapalene + Clindamycin Hydrochloride; 0.1% Adapalene + 1% Clindamycin Hydrochloride; Drug: Adapalene + Clindamycin Hydrochloride; 0.1% Adapalene + 2% Clindamycin Hydrochloride; Drug: Adapalene + Clindamycin Hydrochloride; 0.05% Adapalene + 0.5% Clindamycin Hydrochloride; Drug: Adapalene + Clindamycin Hydrochloride; 0.05% Adapalene + 1% Clindamycin Hydrochloride
Experimental: Treatment group 3; Group 3: 0.05% Adapalene + 0.5% Clindamycin Hydrochloride	Drug: Adapalene + Clindamycin Hydrochloride; 0.1% Adapalene + 1% Clindamycin Hydrochloride; Drug: Adapalene + Clindamycin Hydrochloride; 0.1% Adapalene + 2% Clindamycin Hydrochloride; Drug: Adapalene + Clindamycin Hydrochloride; 0.05% Adapalene + 0.5% Clindamycin Hydrochloride; Drug: Adapalene + Clindamycin Hydrochloride; 0.05% Adapalene + 1% Clindamycin Hydrochloride
Experimental: Treatment group 4; Group 4: 0.05% Adapalene + 1% Clindamycin Hydrochloride	Drug: Adapalene + Clindamycin Hydrochloride; 0.1% Adapalene + 1% Clindamycin Hydrochloride; Drug: Adapalene + Clindamycin Hydrochloride; 0.1% Adapalene + 2% Clindamycin Hydrochloride; Drug: Adapalene + Clindamycin Hydrochloride; 0.05% Adapalene + 0.5% Clindamycin Hydrochloride; Drug: Adapalene + Clindamycin Hydrochloride; 0.05% Adapalene + 1% Clindamycin Hydrochloride
Placebo Comparator: Placebo group; Placebo Group: Blank Gel	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IGA classification change	The improvement of IGA （investigator general Assess）Classification at the treatment end (Day 85±3) in each group	12 weeks
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
PK	AUC	12 weeks
PK	peak plasma concentration	12 weeks

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited
• Investigators: Principal Investigator: Heng GU, MD, Institute of Dermatology, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: October 30, 2015
• First Posted (Estimate): November 1, 2015

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: safety; efficacy
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Adapalene
• Other Study ID Numbers: zhaoke-2015-02