Azelaic Acid on Demodex Counts in Rosacea

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.