Clinical trial NCT00907257: A Study of Different Use Regimens Using Two Acne Treatments
Official title: A Clinical Assessment of the Use of RETIN-A MICRO (Tretinoin Gel) Microsphere, 0.04% in a Pump Dispenser and a 5% Benzoyl Peroxide Wash Used in the Morning Compared to the Use of RETIN-A MICRO 0.04% Pump Nightly and a 5% Benzoyl Peroxide Wash in the Morning For the Treatment of Facial Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: acne
irritation
objective sensory methods
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-22
Enrollment: 247
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 using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.

Detailed description: Approximately 240 subjects will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, all subjects will receive RETIN-A MICRO PUMP 0.04% and a 5% Benzoyl Peroxide wash (OTC) for the entire 12-week treatment period. Subjects will be randomized to either both morning treatments (test) or to the morning/evening treatment (active control). Subjects will be assessed at baseline, at week 3, week 6 and again at the end of therapy, week 12 for number and type of individual lesions and safety. At selected sites, photographs will be taken at the same time points. At Week 12 subjects will be assessed for Investigator's Global Assessment of Acne Severity. The investigator will conduct all of the lesion counts, global assessments and safety assessments.

Eligibility criteria: Inclusion Criteria:

* Males and non-pregnant or non-nursing females, 12 years or older, with facial acne vulgaris;
* Minimum of 20 but no more than 50 inflammatory lesions (papules and pustules);
* Minimum of 30 but no more than 100 facial non-inflammatory lesions (open and closed comedones);
* Must have at least a rating of grade 3 on the Investigator Global severity scale at baseline

Exclusion Criteria:

* Known sensitivity to any of the ingredients in the study medication;
* Any nodulocystic acne lesions;
* Use of acne devices or systemic therapy with antibiotics within two months prior to start and throughout the duration of the study;
* Use of systemic therapy with retinoids within four months prior to study start and throughout the duration of the study;
* Topical use of retinoids within two weeks prior to study start and throughout the duration of the study;
* Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study;
* If subject is taking birth control pills, she must be stabilized for at least three months prior to study start;
* History of evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication;
* Any significant medical conditions that could confound the interpretation of the study;
* Excessive facial hair that may interfere with evaluations;
* No use of tanning booths, sun lamps, etc.

Primary outcomes:
measure: Change From Baseline in Total Facial Acne Lesion Count
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals
timeFrame: Baseline to Week 12
measure: Measurement of Success
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Skin Care Research, Inc.
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Snellville
country: United States
facility: Gwinnett Clinical Research
state: Georgia
city: Louisville
country: United States
facility: Derm Research, PLLC
state: Kentucky
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Stony Brook
country: United States
facility: DermResearch Center of New York
state: New York
city: Cincinnatti
country: United States
facility: Dermatology Research Associates
state: Ohio
city: Yardley
country: United States
facility: Yardley Dermatology Associates
state: Pennsylvania
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Lynchburg
country: United States
facility: Education & Research Foundation, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
name: Ana Rossi, MD
role: STUDY_DIRECTOR
References:
citation: Pariser D, Bucko A, Fried R, Jarratt MT, Kempers S, Kircik L, Lucky AW, Rafal E, Rendon M, Weiss J, Wilson DC, Rossi AB, Ramaswamy R, Nighland M. Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/morning regimen is as effective and safe as morning/evening regimen. J Drugs Dermatol. 2010 Jul;9(7):805-13.