A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
1 other identifier
interventional
180
2 countries
20
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with acne vulgaris.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2010
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedFirst Posted
Study publicly available on registry
September 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJuly 2, 2012
June 1, 2012
1.2 years
September 1, 2010
June 20, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in the number of inflammatory lesions
Baseline and 22 weeks
Percent of patients who achieve success for the acne global severity score
Baseline and 22 weeks
Secondary Outcomes (1)
Change from baseline in the number of non-inflammatory lesions
Baseline and 22 weeks
Study Arms (3)
Low Strength IDP-107
EXPERIMENTALHigh Strength IDP-107
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Presence of acne vulgaris on the face and neck/trunk
- Presence of inflammatory and non-inflammatory lesions on the face
You may not qualify if:
- Presence of any skin condition on the face that could interfere with clinical evaluations
- Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit
- Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit
- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Dermatology Specialists, Inc.
Oceanside, California, 92056, United States
Horizons Clinical Research Center, LLC
Denver, Colorado, 80220, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204, United States
FXM Research Corp.
Miami, Florida, 33175, United States
Ameriderm Research
Ormond Beach, Florida, 32174, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
Pedia Research LLC
Owensboro, Kentucky, 42301, United States
ActivMed Practices and Research, Inc.
Haverhill, Massachusetts, 01830, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124, United States
South Valley Dermatology
West Jordan, Utah, 84088, United States
Premier Clinical Research
Spokane, Washington, 99204, United States
Ultranova Skincare
Barrie, Ontario, L4M 6L2, Canada
The Centre for Dermatology and Cosmetic Surgery
Richmond Hill, Ontario, L4B 1A5, Canada
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2010
First Posted
September 3, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
July 2, 2012
Record last verified: 2012-06