Clinical trial NCT01237821: Comparing OTC Acne Treatment to Prescription Regimen
Official title: A MULTI-CENTER, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF TWO ACNE CREAMS IN SUBJECTS WITH MILD TO MODERATE ACNE VULGARIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Loreal USA
First posted: 2010-11-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is being done to find out the safety and efficacy of two acne creams, Effaclar and Benzaclin when used twice daily with a topical retinoid. Effaclar and Benzaclin are FDA approved for the treatment of acne.

Detailed description: There are many products on the market to treat facial acne. The medication that this study will be evaluating, Benzaclin and Retin-A have been approved by the FDA and is available by prescription, Effaclar is an over the counter product. This study will hopefully recognize a treatment combination that is effective in reducing acne vulgaris in adults 18-50.

Eligibility criteria: Inclusion Criteria:males and females ages 18-50, mild to moderate acne vulgaris with \> or equal to 15 inflammatory lesions, \> or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study

Exclusion Criteria:Participants who have another skin condition that will interfere with lesion counting or assessments

Primary outcomes:
measure: Treatment Tolerability Assessment: Erythema
timeFrame: 16 weeks
measure: Treatment Tolerability Assessment: Edema
timeFrame: 16 weeks
measure: Treatment Tolerability Assessment: Dryness
timeFrame: 16 weeks
measure: Treatment Tolerability Assessment: Peeling
timeFrame: 16 weeks
measure: Facial Skin Assessment: Skin Tone (Clarity)
timeFrame: 16 weeks
measure: Facial Skin Assessment: Skin Smoothness
timeFrame: 16 weeks
measure: Facial Skin Assessment: Skin Brightness
timeFrame: 16 weeks
measure: Facial Skin Assessment: Appearance of Pores
timeFrame: 16 weeks
measure: Facial Skin Assessment: Overall Appearance
timeFrame: 16 weeks
measure: Facial Skin Assessment: Global Acne Assessment
timeFrame: 16 weeks
measure: Facial Lesion Counts: Open Comedones
timeFrame: 16 weeks
measure: Facial Lesion Counts: Closed Comedones
timeFrame: 16 weeks
measure: Facial Lesion Counts: Papules
timeFrame: 16 weeks
measure: Facial Lesion Counts: Pustules
timeFrame: 16 weeks
measure: Facial Lesion Counts: Noninflammatory Lesions
timeFrame: 16 weeks
measure: Facial Lesion Counts: Inflammatory Lesions
timeFrame: 16 weeks
measure: Facial Lesion Counts: Total Lesion
timeFrame: 16 weeks
measure: Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging
timeFrame: 16 weeks
measure: Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling
timeFrame: 16 weeks
measure: Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching
timeFrame: 16 weeks
measure: Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Loreal USA
name: Christian Oresajo, PhD
role: STUDY_DIRECTOR
References: