Comparing OTC Acne Treatment to Prescription Regimen
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
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 9, 2010
CompletedFirst Posted
Study publicly available on registry
November 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
July 16, 2019
CompletedJuly 16, 2019
June 1, 2019
10 months
November 9, 2010
April 24, 2017
June 27, 2019
Conditions
Outcome Measures
Primary Outcomes (21)
Treatment Tolerability Assessment: Erythema
Participants were assessed for Erythema on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Treatment Tolerability Assessment: Edema
Participants were assessed for Edema on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Treatment Tolerability Assessment: Dryness
Participants were assessed for Dryness on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Treatment Tolerability Assessment: Peeling
Participants were assessed for Peeling on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Facial Skin Assessment: Skin Tone (Clarity)
The facial skin was assessed for skin tone (clarity) on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Facial Skin Assessment: Skin Smoothness
The facial skin was assessed for skin smoothness on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Facial Skin Assessment: Skin Brightness
The facial skin was assessed for skin brightness on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Facial Skin Assessment: Appearance of Pores
The facial skin was assessed for the appearance of pores on a 10-point visual analog scale,with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Facial Skin Assessment: Overall Appearance
The facial skin was assessed for overall appearance on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Facial Skin Assessment: Global Acne Assessment
The facial skin was assessed for global acne assessment on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Facial Lesion Counts: Open Comedones
Participants were assessed for facial open comedomes and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Facial Lesion Counts: Closed Comedones
Participants were assessed for facial closed comedomes and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Facial Lesion Counts: Papules
Participants were assessed for facial open comedomes and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Facial Lesion Counts: Pustules
Participants were assessed for facial pustules and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Facial Lesion Counts: Noninflammatory Lesions
Participants were assessed for facial noninflammatory lesions and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Facial Lesion Counts: Inflammatory Lesions
Participants were assessed for facial inflammatory lesions and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Facial Lesion Counts: Total Lesion
Participants were assessed for all facial lesions and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging
Irritation stinging was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling
Irritation tingling was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching
Irritation itching was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning
Irritation burning was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
16 weeks
Study Arms (2)
BenzaClin
ACTIVE COMPARATOREvaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.Inclusion- 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- Participants who have another skin condition that will interfere with lesion counting or assessments
effaclar
ACTIVE COMPARATOREvaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.Inclusion- 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- Participants who have another skin condition that will interfere with lesion counting or assessments
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Milton S. Hershey Medical Centerlead
- Loreal USAcollaborator
Study Sites (1)
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Diane Thiboutot
- Organization
- Penn State Hershey Medical Center
Study Officials
- STUDY DIRECTOR
Christian Oresajo, PhD
Loreal USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RN, CCRC
Study Record Dates
First Submitted
November 9, 2010
First Posted
November 10, 2010
Study Start
October 1, 2010
Primary Completion
August 1, 2011
Study Completion
October 1, 2011
Last Updated
July 16, 2019
Results First Posted
July 16, 2019
Record last verified: 2019-06