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

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

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: CD0271 0.3% / CD1579 2.5%; Drug: CD0271 0.1% / CD1579 2.5%; Drug: Topical Gel Vehicle

• Study Type: Interventional
• Enrollment (Actual): 503
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Barrie, Canada
    • Galderma Investigational Site
  • Markham, Canada
    • Galderma Investigational Site
  • Montreal, Canada
    • Galderma Investiogational Site
  • Peterborough, Canada
    • Galderma Investigational Site
  • Surrey, Canada
    • Galderma Investigational Site
  • Waterloo, Canada
    • Galderma Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Galderma Investigational Site
    • Mobile, Alabama, United States
      • Galderma Investigationnal Site
  • Arkansas
    • Hot Springs, Arkansas, United States
      • Galderma Investigational Site
  • California
    • Los Angeles, California, United States
      • Galderma Investigational Site
    • Sacramento, California, United States
      • Galderma Investigational Site
    • Santa Monica, California, United States
      • Galderma Investigational Site
  • Florida
    • Miami, Florida, United States
      • Galderma Investigational Site
    • Miramar, Florida, United States
      • Galderma Investigational Site
  • Georgia
    • Newnan, Georgia, United States
      • Galderma Investiogational Site
    • Snellville, Georgia, United States
      • Galderma Investigational Site
  • Illinois
    • Chicago, Illinois, United States
      • Galderma Investigational Site
  • Michigan
    • Detroit, Michigan, United States
      • Galderma Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States
      • Galderma Investigational Site
  • New York
    • New York, New York, United States
      • Galderma Investigational Site
    • Stony Brook, New York, United States
      • Galderma Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States
      • Galderma Investigational Site
  • Ohio
    • Beachwood, Ohio, United States
      • Galderma Investigational Site
  • Pennsylvania
    • Hershey, Pennsylvania, United States
      • Galderma Investigational Site
  • South Carolina
    • Greenville, South Carolina, United States
      • Galderma Investigational Site
  • Tennessee
    • Goodlettsville, Tennessee, United States
      • Galderma Investigational Site
    • Knoxville, Tennessee, United States
      • Galderma Investigational Site
  • Texas
    • Arlington, Texas, United States
      • Galderma Investigational Site
    • San Antonio, Texas, United States
      • Galderma Investigational Site
  • Utah
    • Salt Lake City, Utah, United States
      • Galderma Investigational Site
  • Washington
    • Spokane, Washington, United States
      • Galderma Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CD0271 0.3% /CD1579 2.5% Gel; active arm	Drug: CD0271 0.3% / CD1579 2.5%
Active Comparator: CD0271 0.1% / CD1579 2.5%; Comparator arm	Drug: CD0271 0.1% / CD1579 2.5%
Placebo Comparator: Topical Gel Vehicle; Placebo arm	Drug: Topical Gel Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 12
Changes From Baseline in Inflammatory Lesion Counts		Baseline - Week12
Changes From Baseline in Non-Inflammatory Lesion Counts		Baseline - Week 12

Collaborators and Investigators

• Sponsor: Galderma R&D

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: June 14, 2013
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (Estimate): June 18, 2013

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: May 28, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: RD.06.SPR.18240