Azelaic Acid on Demodex Counts in Rosacea

• Status: Completed
• Trial end date: 2012-02-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University
• Treatments: Azelaic acid

Criteria

Inclusion Criteria:

• Male and female subjects, ages 18 and over, with mild to moderate paulopustular rosacea with bilateral facila involvement, who agrees to participate and provide written consent.

• Positive Demodex folliculorum SSSB, defined as >5 mites/cm on at least on of two different SSSB specimens on bilateral sides of teh face.

• Have an IGA of mild to moderate rosacea, rating between 2 and 5.

Exclusion Criteria:

• Use of topical therapy for rosacea or other skin conditions on the face within two weeks of Baseline.

• Use of oral medications for the treatment of rosacea that have been started or altered within the past three months.

• Presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.

• Subjects with known allergy or sensitivity to azelaic acid gel or components therein, such as propylene glycol.

• Subjects with known allergy or sensitivity to cyanoacrylates or formaldehyde.

• Presence of more than two nodules.

• Female subjects who are not postmenopausal for at least 1 year, surgically sterile or willing to practice effective contraception during the study. Reliable methods of birth control are: abstinence, oral contraceptives, intrauterine device, DepoProvera, tubal ligation or vasectomy of the partner in a monogamous relationship. An acceptable, though less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.