Azelaic Acid on Demodex Counts in Rosacea
Azelaic Acid on Demodex Counts in Rosacea
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.
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.
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.