Comparing OTC Acne Treatment to Prescription Regimen

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237821
• Other study ID #: CS1007033A
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: June 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• BenzaClin
Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
• Effaclar
Topical, Bid, 12 weeks

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Loreal USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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