A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris - Full Text View

Sponsor:	Dow Pharmaceutical Sciences
Information provided by (Responsible Party):	Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:	NCT01194375

Purpose

The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with acne vulgaris.

Condition	Intervention	Phase
Acne Vulgaris	Drug: Low Strength IDP-107 Drug: High Strength IDP-107 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Acne

U.S. FDA Resources

Further study details as provided by Dow Pharmaceutical Sciences:

Primary Outcome Measures:

Change from baseline in the number of inflammatory lesions [ Time Frame: Baseline and 22 weeks ] [ Designated as safety issue: No ]
Percent of patients who achieve success for the acne global severity score [ Time Frame: Baseline and 22 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in the number of non-inflammatory lesions [ Time Frame: Baseline and 22 weeks ] [ Designated as safety issue: No ]

Enrollment:	180
Study Start Date:	September 2010
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Low Strength IDP-107	Drug: Low Strength IDP-107 Once a day for 16 weeks
Experimental: High Strength IDP-107	Drug: High Strength IDP-107 Once a day for 16 weeks
Placebo Comparator: Placebo	Drug: Placebo Once a day for 16 weeks

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Presence of acne vulgaris on the face and neck/trunk
Presence of inflammatory and non-inflammatory lesions on the face

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194375

Locations

United States, California
Dermatology Specialists, Inc.
Oceanside, California, United States, 92056
United States, Colorado
Horizons Clinical Research Center, LLC
Denver, Colorado, United States, 80220
United States, Florida
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States, 32204
FXM Research Corp.
Miami, Florida, United States, 33175
Ameriderm Research
Ormond Beach, Florida, United States, 32174
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States, 46168
United States, Kentucky
Pedia Research LLC
Owensboro, Kentucky, United States, 42301
United States, Massachusetts
ActivMed Practices and Research, Inc.
Haverhill, Massachusetts, United States, 01830
United States, Michigan
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
United States, Oregon
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
United States, Utah
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States, 84124
South Valley Dermatology
West Jordan, Utah, United States, 84088
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99204
Canada, Ontario
Ultranova Skincare
Barrie, Ontario, Canada, L4M 6L2
The Centre for Dermatology and Cosmetic Surgery
Richmond Hill, Ontario, Canada, L4B 1A5
K. Papp Clinical Research
Waterloo, Ontario, Canada, N2J 1C4

Sponsors and Collaborators

Dow Pharmaceutical Sciences

More Information

No publications provided

Responsible Party:	Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:	NCT01194375 History of Changes
Other Study ID Numbers:	DPSI-IDP-107-P2-02
Study First Received:	September 1, 2010
Last Updated:	February 6, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Additional relevant MeSH terms:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on May 23, 2012