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

Primary Purpose

Acne

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Adapalene + Clindamycin Hydrochloride
Adapalene + Clindamycin Hydrochloride
Adapalene + Clindamycin Hydrochloride
Adapalene + Clindamycin Hydrochloride
Placebo
Sponsored by
Lee's Pharmaceutical Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne focused on measuring safety, efficacy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Dermatology, Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Treat group 1

Treatment group 2

Treatment group 3

Treatment group 4

Placebo group

Arm Description

Group 1: 0.1% Adapalene + 1% Clindamycin Hydrochloride

Group 2: 0.1% Adapalene + 2% Clindamycin Hydrochloride

Group 3: 0.05% Adapalene + 0.5% Clindamycin Hydrochloride

Group 4: 0.05% Adapalene + 1% Clindamycin Hydrochloride

Placebo Group: Blank Gel

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 16, 2015
Last Updated
September 23, 2019
Sponsor
Lee's Pharmaceutical Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02593383
Brief Title
Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lee's Pharmaceutical Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
safety, efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treat group 1
Arm Type
Experimental
Arm Description
Group 1: 0.1% Adapalene + 1% Clindamycin Hydrochloride
Arm Title
Treatment group 2
Arm Type
Experimental
Arm Description
Group 2: 0.1% Adapalene + 2% Clindamycin Hydrochloride
Arm Title
Treatment group 3
Arm Type
Experimental
Arm Description
Group 3: 0.05% Adapalene + 0.5% Clindamycin Hydrochloride
Arm Title
Treatment group 4
Arm Type
Experimental
Arm Description
Group 4: 0.05% Adapalene + 1% Clindamycin Hydrochloride
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo Group: Blank Gel
Intervention Type
Drug
Intervention Name(s)
Adapalene + Clindamycin Hydrochloride
Intervention Description
0.1% Adapalene + 1% Clindamycin Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Adapalene + Clindamycin Hydrochloride
Intervention Description
0.1% Adapalene + 2% Clindamycin Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Adapalene + Clindamycin Hydrochloride
Intervention Description
0.05% Adapalene + 0.5% Clindamycin Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Adapalene + Clindamycin Hydrochloride
Intervention Description
0.05% Adapalene + 1% Clindamycin Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
efficacy endpoint
Description
number of patients with deceased acne lesions at the treatment end (Day 85±3) in each group;
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
IGA classification change
Description
The improvement of IGA (investigator general Assess)Classification at the treatment end (Day 85±3) in each group
Time Frame
12 weeks
Title
treatment success rate
Description
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
Time Frame
12 weeks
Title
PK
Description
AUC
Time Frame
12 weeks
Title
PK
Description
peak plasma concentration
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heng GU, MD
Organizational Affiliation
Institute of Dermatology, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Dermatology, Chinese Academy of Medical Sciences
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210042
Country
China

12. IPD Sharing Statement

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

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