Clinical trial NCT01138735: Epiduo Pediatric Acne Study
Official title: A Multi-center, Randomized, Vehicle-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Administered Once Daily for the Treatment of Subjects 9 to 11 Years of Age With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-06-07
Enrollment: 285
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acne vulgaris with facial involvement
* Score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale
* A minimum of 20 but not more than 100 total lesions (Noninflammatory and/or Inflammatory) on the face (including the nose) at Baseline

Exclusion Criteria:

* Acne nodule or acne cyst
* Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment
* Underlying diseases and/or dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments
* Use of prohibited medications prior to the study and/or are unwilling to refrain from such use during the study

Primary outcomes:
measure: Success Rate
timeFrame: Baseline to Week 12 (Last Observation Carried Forward [LOCF])
measure: Change From Baseline in Total Lesion Counts
timeFrame: Baseline to Week 12 (LOCF)
Secondary outcomes:
measure: Percent Change in Total Lesion Counts From Baseline
timeFrame: Baseline to Week 12 (LOCF)
measure: Change in Inflammatory Lesion Counts From Baseline
timeFrame: Baseline to Week 12 (LOCF)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Dermatology Clinical Research
state: Alabama
city: San Diego
country: United States
facility: Children's Hospital and Health Center Division of Pediatric and Adolescent Dermatology
state: California
city: Santa Rosa
country: United States
facility: Redwood Family Dermatology
state: California
city: Miramar
country: United States
facility: FXM Research Miramar
state: Florida
city: Overland Park
country: United States
facility: Adult & Pediatric Dermatology
state: Kansas
city: Louisville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Health Systems Department of Dermatology
state: Michigan
city: Troy
country: United States
facility: Dermcenter PC - Somerset Skin Centre
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center A Division of Associated Skin Care Specialists, PA
state: Minnesota
city: Saint Louis
country: United States
facility: Central Dermatology PC
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: High Point
country: United States
facility: Zoe Draelos, MD
state: North Carolina
city: Winston-Salem
country: United States
facility: Department of Dermatology - Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: Cininnati Children's Hospital
state: Ohio
city: South Euclid
country: United States
facility: Haber Dermatology Clinical Research Center
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center - Penn State College of Medicine
state: Pennsylvania
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Kingsport
country: United States
facility: Dermatology Associates of Kingsport, PC
state: Tennessee
city: Houston
country: United States
facility: The University of Texas Health Sciences Center at Houston
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Surrey
country: Canada
facility: Guildford Dermatology Specialists
state: British Columbia
city: St John's
country: Canada
facility: Nexus Clinical Research
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research, Inc
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
Study officials:
affiliation: Galderma R&D
name: Michael Graeber, MD
role: STUDY_DIRECTOR
affiliation: Guildford Dermatology Specialists
name: Lorne Albrecht, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zoe Draelos, MD
name: Zoe Draelos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Childrens Hospital and Health Center Division of Pediatric and Adolescent Dermatology
name: Lawrence Eichenfield, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UAB Dermatology Clinical Research
name: Boni Elewski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Dermatology Wake Forest University Health Sciences
name: Alan Fleischer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: FXM Research Miramar
name: Francisco Flores, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Specialists Research
name: Joseph Fowler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haber Dermatology Clinical Research Center
name: Robert Haber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Adelaide Hebert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Dermatology, PC
name: Michael Heffernan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Adult & Pediatric Dermatology
name: David Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Minnesota Clinical Study Center A Division of Associated Skin Care Specialist, PA
name: Steven Kempers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ultranova Skincare
name: Rodion Kunynetz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nexus Clinical Research
name: Ian Landells, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lynderm Research Inc.
name: Charles Lynde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Associates of Kingsport, PC
name: Russell Mader, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Bay Dermatology Centre
name: Lew Andrew Rosoph, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skin Specialists, PC
name: Joel Schlessenger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Michael Spigarelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Health Systems - Department of Dermatology
name: Linda Stein Gold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Redwood Family Dermatology
name: Jeffrey Sugarman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Premier Clinical Research
name: William Werschler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palmetto Clinical Trial Services, LLC
name: Patricia Westmoreland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State Milton S. Hershey Medical Center - Penn State College of Medicine
name: Andrea Zaenglein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermcenter PC; Somerset Skin Centre
name: George Murakawa, MD
role: PRINCIPAL_INVESTIGATOR
References: