A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea

FINACEA® (azelaic acid) GEL, 15% contains azelaic acid, a naturally occurring saturated
dicarboxylic acid that has proven anti-inflammatory effects, as well as anti-keratinizing
and antimicrobial action, although its mechanism of action in rosacea is not well
understood. This study will be conducted in compliance with the protocol, Good Clinical
Practices (GCP) and the applicable regulatory requirement(s). Marketed by Intendis, Finacea®
(azelaic acid) Gel, 15% is a safe and effective topical therapy used for the treatment of
moderate facial rosacea. Watson Laboratories, Inc. has developed a generic formulation of
azelaic acid 15% gel and the current study is designed to evaluate the safety and efficacy
of this formulation.

Inclusion Criteria:

- Healthy male or non-pregnant female ≥18 years-of-age with a clinical diagnosis of
moderate facial rosacea.

- Patient must have at least eight and not more than fifty inflammatory facial lesions
(i.e., papules/pustules) and ≤2 nodules on the face. For the purposes of study
treatment and evaluation, these lesions should be limited to the facial treatment
area including those present on the nose. Lesions involving the eyes, and scalp
should be excluded from the count.

- Patients must have persistent erythema on the face with moderate (Definite redness,
easily recognized) to Severe (Marked erythema; fiery red).

- Patients must have a mild to moderate score for telangiectasia on the face - Patients
must have a definite clinical diagnosis of moderate facial rosacea as per the IGE

- Patient must be willing to minimize external factors that might trigger rosacea
flare-ups (e.g., spicy foods, thermally hot foods and drinks, hot environments,
prolonged sun exposure, strong winds and alcoholic beverages).

- Patient must be in general good health and free from any clinically significant
disease other than rosacea, that might interfere with the study evaluations.

- Patient must be willing and able to understand and comply with the requirements of
the study, apply the medication as instructed, return for the required treatment
period visits, comply with therapy prohibitions, and be able to complete the study.

- Female Subjects of childbearing potential (excluding women who are
surgicallysterilized or postmenopausal for at least 1 year), in addition to having a
negative urine pregnancy test, must be willing to use an acceptable form of birth
control during the study from the day of the first dose administration to 30 days
after the last administration of study drug For the purpose of this study the
following are considered acceptable methods of birth control: oral contraceptives,
contraceptive patches, contraceptive implant, vaginal contraceptive, double barrier
methods (e.g., condom and spermicide), contraceptive injection (Depo-provera®),
intrauterine device (IUD), hormonal IUD (Mirena®) and abstinence with a documented
second acceptable method of birth control, should the patient become sexually active.
Patients on hormonal contraception must be stabilized on the same type for at least
three months prior to enrollment in the study and must not change the hormonal
contraception during the study. Patients who had used hormonal contraception and
stopped must have stopped no less than three months prior to the study. A sterile
sexual partner is NOT considered an adequate form of birth control.

- All male patients must agree to use accepted methods of birth control with their
partners, from the day of the first dose administration to 30 days after the last
administration of study drug. Abstinence is an acceptable method of birth control.
Female partners should use an acceptable method of birth control as described in the
above Item Number 10.

- Patients who use make-up must have used the same brands/types of make-up for a
minimum period of 14 days prior to study entry and must agree to use the same
make-up, brand/type, or frequency of use, throughout the study.

Exclusion Criteria:

- Pregnant or lactating or planning to become pregnant during the study period.

- Presence of any skin condition on the face that would interfere with the diagnosis or
assessment of rosacea.

- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere
with diagnosis or assessment of rosacea.

- History of hypersensitivity or allergy to azelaic acid, propylene glycol or any other
component of the formulation.

- The use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or
therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are
allowed).

- The use of estrogens or oral contraceptives for less than 3 months prior to baseline.

- The use within 1 month prior to baseline of:

1. topical retinoids to the face;

2. systemic antibiotics known to have an impact on the severity of facial rosacea
(e.g., containing tetracycline and its derivatives, erythromycin and its
derivatives, sulfamethoxazole, or trimethoprim);

3. systemic corticosteroids (Note: intranasal and inhalational corticosteroids do
not require a washout and maybe used throughout the trial if the subject is on a
stable dose).

- Use within 2 weeks prior to baseline of:

1. topical corticosteroids;

2. topical antibiotics;

3. topical medications for rosacea (e.g., metronidazole).

- Patients with moderate or severe rhinophyma, dense telangiectases (score 3, severe),
or plaque-like facial edema.

- Patients with a severe irritation grade for erythema, dryness, scaling, pruritus,
stinging/burning, and edema.

- Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient
severity to require topical or systemic antibiotics.

- A patient who has used a sauna during the 2 weeks prior to study entry and during the
study.

- Patients who have performed wax epilation of the face within 14 days prior to
baseline

- A patient who has a history of being unresponsive to topical azelaic acid therapy.

- A patient with bacterial folliculitis.

- A patient who consumes excessive alcohol, abuses licit or illicit drugs, or has a
condition that could compromise the patient's ability to comply with study
requirements.

- Patients who engage in activities that involve excessive or prolonged exposure to
sunlight or weather extremes, such as wind or cold.

- A patient who has any clinically significant condition or situation, other than the
condition being studied that, in the opinion of the Investigator, would interfere
with the study evaluations or optimal participation in the study.

- A patient who has used any topical azelaic acid therapy within 30 days of baseline
visit.

- Patients who have participated in an investigational drug study (i.e., patients have
been treated with an Investigational Drug) within 30 days prior to baseline will be
excluded from study participation. Patients who are participating in non-treatment
studies such as observational studies or registry studies can be considered for
inclusion.

- Patients who have been previously enrolled in this study.

- Patients who have had laser therapy (for telangiectasia or other conditions),
electrodessication and phototherapy (e.g., ClearLight®) to the facial area within 180
days prior to study entry.

- Patients who have had cosmetic procedures (e.g., facials) which may affect the
efficacy and safety profile of the Investigational Product within 14 days prior to
study entry.