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Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CD0271 0.3% / CD1579 2.5%
CD0271 0.1% / CD1579 2.5%
Topical Gel Vehicle
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female, who is 12 years of age or older at Screening visit.
  2. Clinical diagnosis of acne vulgaris with facial involvement.
  3. An IGA of Moderate (3) or Severe (4) at Baseline visit.
  4. A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit.
  5. A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at Baseline visit.

Exclusion Criteria:

  1. More than 2 acne nodules on the face at Baseline visit.
  2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
  3. Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This includes clinically significant abnormal findings, uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
  4. The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit
  5. The subject is unwilling to refrain from use of prohibited medication during the clinical trial.
  6. Use of hormonal contraceptives solely for control of acne.

Sites / Locations

  • Galderma Investigational site
  • Galderma Investigationnal Site
  • Galderma investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investiogational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investiogational Site
  • Galderma Investigational Site
  • Galderma Investigational site
  • Galderma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

CD0271 0.3% /CD1579 2.5% Gel

CD0271 0.1% / CD1579 2.5%

Topical Gel Vehicle

Arm Description

active arm

Comparator arm

Placebo arm

Outcomes

Primary Outcome Measures

Success Rate
Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.
Changes From Baseline in Inflammatory Lesion Counts
Changes From Baseline in Non-Inflammatory Lesion Counts

Secondary Outcome Measures

Full Information

First Posted
June 14, 2013
Last Updated
May 28, 2018
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01880320
Brief Title
Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris
Official Title
A Multi-center, Randomized, Double-blind, Parallel-group Vehicle and Active Controlled Study to Compare the Efficacy and Safety of CD0271 0.3% / CD1579 2.5% Topical Gel Versus Topical Gel Vehicle in Subjects With Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study hypothesis are based on the assumption that : CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
503 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CD0271 0.3% /CD1579 2.5% Gel
Arm Type
Experimental
Arm Description
active arm
Arm Title
CD0271 0.1% / CD1579 2.5%
Arm Type
Active Comparator
Arm Description
Comparator arm
Arm Title
Topical Gel Vehicle
Arm Type
Placebo Comparator
Arm Description
Placebo arm
Intervention Type
Drug
Intervention Name(s)
CD0271 0.3% / CD1579 2.5%
Intervention Type
Drug
Intervention Name(s)
CD0271 0.1% / CD1579 2.5%
Intervention Type
Drug
Intervention Name(s)
Topical Gel Vehicle
Primary Outcome Measure Information:
Title
Success Rate
Description
Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.
Time Frame
Week 12
Title
Changes From Baseline in Inflammatory Lesion Counts
Time Frame
Baseline - Week12
Title
Changes From Baseline in Non-Inflammatory Lesion Counts
Time Frame
Baseline - Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, who is 12 years of age or older at Screening visit. Clinical diagnosis of acne vulgaris with facial involvement. An IGA of Moderate (3) or Severe (4) at Baseline visit. A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit. A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at Baseline visit. Exclusion Criteria: More than 2 acne nodules on the face at Baseline visit. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment. Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This includes clinically significant abnormal findings, uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial. The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit The subject is unwilling to refrain from use of prohibited medication during the clinical trial. Use of hormonal contraceptives solely for control of acne.
Facility Information:
Facility Name
Galderma Investigational site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Galderma Investigationnal Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Galderma investigational Site
City
Hot Springs
State/Province
Arkansas
Country
United States
Facility Name
Galderma Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Galderma Investigational Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
Galderma Investigational Site
City
Santa Monica
State/Province
California
Country
United States
Facility Name
Galderma Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Galderma Investigational Site
City
Miramar
State/Province
Florida
Country
United States
Facility Name
Galderma Investiogational Site
City
Newnan
State/Province
Georgia
Country
United States
Facility Name
Galderma Investigational Site
City
Snellville
State/Province
Georgia
Country
United States
Facility Name
Galderma Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Galderma Investigational Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Galderma Investigational Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Galderma Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Galderma Investigational Site
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
Galderma Investigational Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Galderma Investigational Site
City
Beachwood
State/Province
Ohio
Country
United States
Facility Name
Galderma investigational Site
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Galderma Investigational Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Galderma Investigational Site
City
Goodlettsville
State/Province
Tennessee
Country
United States
Facility Name
Galderma Investigational Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Galderma Investigational Site
City
Arlington
State/Province
Texas
Country
United States
Facility Name
Galderma Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Galderma Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Galderma Investigational Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Galderma Investigational Site
City
Barrie
Country
Canada
Facility Name
Galderma Investigational Site
City
Markham
Country
Canada
Facility Name
Galderma Investiogational Site
City
Montreal
Country
Canada
Facility Name
Galderma Investigational Site
City
Peterborough
Country
Canada
Facility Name
Galderma Investigational site
City
Surrey
Country
Canada
Facility Name
Galderma Investigational Site
City
Waterloo
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28686776
Citation
Stein Gold L, Werschler WP, Mohawk J. Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: Effective Acne Therapy Regardless of Age or Gender. J Drugs Dermatol. 2017 Jun 1;16(6):582-589.
Results Reference
derived
PubMed Identifier
28686775
Citation
Alexis AF, Cook-Bolden FE, York JP. Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: A Safe and Effective Acne Therapy in All Skin Phototypes. J Drugs Dermatol. 2017 Jun 1;16(6):574-581.
Results Reference
derived
PubMed Identifier
26945741
Citation
Stein Gold L, Weiss J, Rueda MJ, Liu H, Tanghetti E. Moderate and Severe Inflammatory Acne Vulgaris Effectively Treated with Single-Agent Therapy by a New Fixed-Dose Combination Adapalene 0.3 %/Benzoyl Peroxide 2.5 % Gel: A Randomized, Double-Blind, Parallel-Group, Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):293-303. doi: 10.1007/s40257-016-0178-4.
Results Reference
derived

Learn more about this trial

Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris

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