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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880320
• Other study ID #: RD.06.SPR.18240
• Status: Completed
• Phase: Phase 3
• Start date: July 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2018
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• CD0271 0.3% / CD1579 2.5%

• CD0271 0.1% / CD1579 2.5%

• Topical Gel Vehicle

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Changes From Baseline in Inflammatory Lesion Counts		Baseline - Week12
Primary	Changes From Baseline in Non-Inflammatory Lesion Counts		Baseline - Week 12