A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Intervention: Azelaic acid; Vehicle; Finacea
Intervention description: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.; Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.; Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Intervention MeSH terms: Azelaic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1009.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate facial rosacea; Azelaic acid; Rosacea

Summary:

      The purpose of the study is to compare the safety and efficacy profiles of a generic Azelaic
      Acid Gel, 15% to the reference listed Finacea® (azelaic acid) Gel, 15% in the treatment of
      moderate facial rosacea.
    

Eligibility criteria:

        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.