Clinical trial NCT01326780: A Study of a New Drug Treatment for Acne
Official title: A Multi-Center, Double-Blind, Vehicle Controlled, Phase II Study of JNJ 10229570-AAA for the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: Acne
Irritation
Safety
Sebum
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-31
Enrollment: 431
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: A study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient.

Detailed description: Approximately 400 male and female subjects with moderate facial acne vulgaris will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, subjects will be randomized to either 1.2%, 2.4%, or 3.6% facial cream (JNJ 10229570-AAA) or color-matched vehicle. Subjects will apply the study medication once daily on the face for 12 weeks. Safety will be monitored throughout the study duration. Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at Baseline and at Weeks 2, 4, 6, 8, 10, and 12. Approximately 50 subjects from one investigational site also will have serums collected at Weeks 6 and 12 for evaluation of the multiple dose pharmacokinetics of JNJ 10229570-AAA cream.

Eligibility criteria: Inclusion Criteria:

* 12 years of age or older, with moderate facial acne vulgaris as defined in the protocol
* If female of childbearing potential, must take a pregnancy test and have a negative result
* Females of childbearing potential must also agree to use an adequate method of birth control, which would include:

  * systemic birth control (Subjects must have been taking the same type of birth control for at least 3 months prior to entering the study and must not change type of birth control during the study)
  * Condom with spermicide
  * IUD. Females who have had a hysterectomy, bilateral oophorectomy or bilateral tubal ligation are not required to use additional birth control methods

Exclusion Criteria:

* Known sensitivity to any of the ingredients in the study medication
* More than 3 nodulocystic acne lesions
* Use of acne treatments, therapies or medications within protocol-specified timeframes
* Presence of other skin conditions, diseases, or medical conditions that (per protocol or in the opinion of the investigator) may require concurrent therapy, interfere with the evaluation of the study medication, or compromise subject safety
* Excessive facial hair that may interfere with application of the medication and/or evaluations

Primary outcomes:
measure: Change in Total Acne Lesion Counts
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change From Baseline in the Non-inflammatory Acne Lesion Counts
timeFrame: Baseline through Week 12
measure: Change From Baseline in the Inflammatory Acne Lesion Counts
timeFrame: Baseline through Week 12
measure: Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts
timeFrame: Baseline through Week 12
measure: Percent Change From Baseline in the Inflammatory Acne Lesion Counts
timeFrame: Baseline through Week 12
measure: Percent Change From Baseline in Total Acne Lesion Counts
timeFrame: Baseline through Week 12.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Diego
country: United States
facility: University Clinical Trials, Inc.
state: California
city: Colorado Springs
country: United States
facility: Thomas J. Stephens & Associates, Inc.
state: Colorado
city: Denver
country: United States
facility: Horizons Clinical Research Ctr., LLC
state: Colorado
city: Jacksonville
country: United States
facility: North Florida Dermatology
state: Florida
city: Saint Petersburg
country: United States
facility: Hilltop Research
state: Florida
city: Snellville
country: United States
facility: Gwinnett Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Louisville
country: United States
facility: Dermatology Specialists Research, Inc
state: Kentucky
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Rochelle Park
country: United States
facility: TKL Research
state: New Jersey
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Miamiville
country: United States
facility: Hilltop Research
state: Ohio
city: Hershey
country: United States
facility: Penn State Medical Center
state: Pennsylvania
city: Yardley
country: United States
facility: Yardley Dermatology Associates
state: Pennsylvania
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Irving
country: United States
facility: Reliance Clinical Testing Services
state: Texas
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Johnson Varughese
role: STUDY_DIRECTOR
References: