Azelaic Acid on Demodex Counts in Rosacea

Completed · Phase 2/Phase 3

Conditions studied: Rosacea

In brief

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.

Key facts

Study ID

NCT03035955

Run by

Wake Forest University

People needed

20

Starts

2010-12-01

Expected to finish

2012-02-02

Last updated by the study team

2018-09-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Wake Forest University Health Sciences Department of Dermatology — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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