Clinical trial NCT01194375: A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Dow Pharmaceutical Sciences
Sponsor class: INDUSTRY
First posted: 2010-09-03
Enrollment: 180
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 purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with acne vulgaris.


Eligibility 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

Primary outcomes:
measure: Change from baseline in the number of inflammatory lesions
timeFrame: Baseline and 22 weeks
measure: Percent of patients who achieve success for the acne global severity score
timeFrame: Baseline and 22 weeks
Secondary outcomes:
measure: Change from baseline in the number of non-inflammatory lesions
timeFrame: Baseline and 22 weeks
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates, PA
state: Florida
city: Miami
country: United States
facility: FXM Research Corp.
state: Florida
city: Ormond Beach
country: United States
facility: Ameriderm Research
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Owensboro
country: United States
facility: Pedia Research LLC
state: Kentucky
city: Haverhill
country: United States
facility: ActivMed Practices and Research, Inc.
state: Massachusetts
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: West Jordan
country: United States
facility: South Valley Dermatology
state: Utah
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology and Cosmetic Surgery
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
Study officials:
References: