Clinical trial NCT01880320: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-06-18
Enrollment: 503
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Success Rate
timeFrame: Week 12
measure: Changes From Baseline in Inflammatory Lesion Counts
timeFrame: Baseline - Week12
measure: Changes From Baseline in Non-Inflammatory Lesion Counts
timeFrame: Baseline - Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Galderma Investigational site
state: Alabama
city: Mobile
country: United States
facility: Galderma Investigationnal Site
state: Alabama
city: Hot Springs
country: United States
facility: Galderma investigational Site
state: Arkansas
city: Los Angeles
country: United States
facility: Galderma Investigational Site
state: California
city: Sacramento
country: United States
facility: Galderma Investigational Site
state: California
city: Santa Monica
country: United States
facility: Galderma Investigational Site
state: California
city: Miami
country: United States
facility: Galderma Investigational Site
state: Florida
city: Miramar
country: United States
facility: Galderma Investigational Site
state: Florida
city: Newnan
country: United States
facility: Galderma Investiogational Site
state: Georgia
city: Snellville
country: United States
facility: Galderma Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Galderma Investigational Site
state: Illinois
city: Detroit
country: United States
facility: Galderma Investigational Site
state: Michigan
city: Albuquerque
country: United States
facility: Galderma Investigational Site
state: New Mexico
city: New York
country: United States
facility: Galderma Investigational Site
state: New York
city: Stony Brook
country: United States
facility: Galderma Investigational Site
state: New York
city: Raleigh
country: United States
facility: Galderma Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: Galderma Investigational Site
state: Ohio
city: Hershey
country: United States
facility: Galderma investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: Galderma Investigational Site
state: South Carolina
city: Goodlettsville
country: United States
facility: Galderma Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Galderma Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: Galderma Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Galderma Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Galderma Investigational Site
state: Utah
city: Spokane
country: United States
facility: Galderma Investigational Site
state: Washington
city: Barrie
country: Canada
facility: Galderma Investigational Site
city: Markham
country: Canada
facility: Galderma Investigational Site
city: Montreal
country: Canada
facility: Galderma Investiogational Site
city: Peterborough
country: Canada
facility: Galderma Investigational Site
city: Surrey
country: Canada
facility: Galderma Investigational site
city: Waterloo
country: Canada
facility: Galderma Investigational Site
Study officials:
References:
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.
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.
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.