NCT01237821

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

Completed NA Results posted Last updated 27 June 2019

What this trial tests

NA trial testing BenzaClin in Acne Vulgaris in 66 participants. Completed in 1 October 2011.

Timeline

1 October 2010

Primary endpoint
1 August 2011

1 October 2011

Quick facts

Lead sponsor	Milton S. Hershey Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	66
Start date	1 October 2010
Primary completion	1 August 2011
Estimated completion	1 October 2011
Sites	1 location across United States

Drugs / interventions tested

• BenzaClin — full drug profile →
• Effaclar — full drug profile →

Conditions studied

• Acne Vulgaris — all drugs for Acne Vulgaris →

Sponsor

Milton S. Hershey Medical Center

Who can join

Adults 18 to 50, any sex, with Acne Vulgaris. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Treatment Tolerability Assessment: Erythema
  Time frame: 16 weeks
  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.
• Treatment Tolerability Assessment: Edema
  Time frame: 16 weeks
  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.
• Treatment Tolerability Assessment: Dryness
  Time frame: 16 weeks
  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.
• Treatment Tolerability Assessment: Peeling
  Time frame: 16 weeks
  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.
• Facial Skin Assessment: Skin Tone (Clarity)
  Time frame: 16 weeks
  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.
• Facial Skin Assessment: Skin Smoothness
  Time frame: 16 weeks
  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.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Topical benzoyl peroxide for acne.
   Yang Z, Zhang Y, Lazic Mosler E, Hu J, et al · · 2020 · cited 29× · PMID 32175593 · DOI 10.1002/14651858.cd011154.pub2