Clinical Trial: Azelaic Acid on Demodex Counts in Rosacea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effect of Azelaic Acid (Financea Gel 15%) on Demodex Folliculorum Counts in Adult Subjects With Mild to Moderate Papulopustular Rosacea

Brief Summary: The purpose of this study is to measure the effects of azelaic acid on Demodex folliculorum counts and disease condition via a split face design in approximately twenty patients with mild to moderate rosacea. The investigators hypothesize that treatment of rosacea with azelaic acid will lead to a decreased Demodex folliculorum count as well as an improvement in lesion count and redness.

Detailed Summary: This is a split face, randomized, single blind, single center study. Male and female (non-pregnant, non-nursing) subjects, age 18 or greater, with mild to moderate papulopustular facial rosacea, with bilateral facial involvement, and no more than two nodules will be enrolled. Subjects will be randomized 1:1 by the study coordinator using a standard randomization table to receive azelaic acid twice daily on either the left side or the right side of the face and no treatment on the other side of the face. Subjects must have a positive Demodex folliculorum standardized skin surface biopsy, defined at >5 mites cm at Screening/Baseline on at least one of two different SSSB specimens on bilateral sides of the face. The SSSB test location will ideally be on the cheek, but may be done in the most disease involved area. Subjects will be seen at Screening/Baseline, Week 1 and Week 4. Standard topical washout periods will be observed. At each visit, rosacea will be evaluated by lesion count, IGA and two Demodex SSSB tests done on each side of the face. Safety will be monitored at each visit using the Investigator Skin Irritation Assessment.
Sponsor: Wake Forest University

Current Primary Outcome:

  • IGA of clear/minimal [ Time Frame: Week 4 ]
    IGA of clear/minimal (0/1 on a 7 point scale);
  • lesion Count [ Time Frame: Week 4 ]
    reduction in lesion count
  • Demodex reduction [ Time Frame: week 4 ]
    >50% reduction of Demodex count


Original Primary Outcome: Same as current

Current Secondary Outcome: Investigator Skin Irritation Assessments [ Time Frame: Week 4 ]

Investigator Skin Irritation Assessment integrates all areas of the skin for overall score. The measure will be used as a quick, simple way to evaluate symptoms of skin irritation. Scores range from 0 = "Completely clear" to 4 = "Severe irritation"


Original Secondary Outcome: Same as current

Information By: Wake Forest University Health Sciences

Dates:
Date Received: December 19, 2012
Date Started: December 2010
Date Completion:
Last Updated: January 26, 2017
Last Verified: January 2017