A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea

Rosacea Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate Safety and Clinical Equivalence of a Generic Azelaic Acid Foam, 15% and the Reference Listed Finacea® (Azelaic Acid) Foam,15% in Patients With Moderate Facial Rosacea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03287791
• Other study ID #: ACTA/AZEL/2015
• Status: Completed
• Phase: Phase 3
• Start date: July 19, 2016
• Est. completion date: June 22, 2017

Study information

• Verified date: July 2019
• Source: Actavis Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of this study were to compare the safety and efficacy profiles of a generic Azelaic Acid Foam, 15% to the reference listed Finacea® (azelaic acid) Foam, 15% and to demonstrate therapeutic equivalence and safety of the two active foams in the treatment of moderate facial rosacea, and to demonstrate superiority of the Reference and Test products over the Vehicle.

Description:

Topical azelaic acid is used to treat inflammatory papules and pustules of mild to moderate rosacea. Other topical therapies and oral antibiotics are also used to treat rosacea symptoms. Finacea® (azelaic acid) Foam, 15% contains azelaic acid, a naturally occurring saturated dicarboxylic acid that has proven anti-inflammatory effects, as well as anti-keratinizing and antimicrobial actions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 924
• Est. completion date: June 22, 2017
• Est. primary completion date: June 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants had to be willing and able to provide written informed consent for the study

• Healthy males or non-pregnant females =18 years-of-age with a clinical diagnosis of moderate facial rosacea

• Participants had to have at least 8 and not more than 50 inflammatory facial lesions (that is, papules/pustules) and =2 nodules on the face. For the purposes of study treatment and evaluation, these lesions were limited to the facial treatment area including those present on the nose. Lesions involving the eyes and scalp were excluded from the count.

• Participants had to have persistent erythema on the face with moderate (3) score

• Participants had to have a mild (1) to moderate (2) score for telangiectasia on the face

• Participants had to have a definite clinical diagnosis of moderate facial rosacea (severity score 3)

• Participants had to be willing to minimize external factors that might trigger rosacea flare-ups (for example, spicy foods, thermally hot foods and drinks, hot environments, prolonged sun exposure, strong winds, and alcoholic beverages) during the course of the study

• Participants had to be in general good health and free from any clinically significant disease other than rosacea on the face, that could have interfered with the study evaluations

• Participants had to 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 able to complete the study

• Male participants and female participants of childbearing potential had to use accepted methods of birth control or had to agree to practice abstinence, from study start to 30 days after the last administration of study drug. All female participants were considered to be of childbearing potential unless they had been surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or had been postmenopausal for at least a year. Any of the following methods of birth control were acceptable: oral contraceptives, contraceptive patches/implants (for example, Norplant®), vaginal ring (NuvaRing®), Depo-Provera® (Medroxy progesterone acetate), double barrier methods (for example, condom and spermicide), or intrauterine device

• Female participants of child bearing potential had to have a negative urine pregnancy test at baseline

• Participants who used make-up had to have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and had to 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 could have interfered with the diagnosis or assessment of rosacea

• Excessive facial hair (for example, beards, sideburns, moustaches) that would interfere could have interfered 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 (for example, Accutane®) or therapeutic Vitamin A supplements of greater than 10,000 units/day (multivitamins were 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 the following:

• topical retinoids to the face

• systemic antibiotics known to have an impact on the severity of facial rosacea (for example, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim)

• systemic corticosteroids

• Use within two weeks prior to baseline of the following:

• topical corticosteroids

• topical antibiotics

• topical medications for rosacea (for example, metronidazole, azelaic acid)

• Antipruritics, including antihistamines, within 24 hours of any study visit

• Participants with moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema

• Participants with a severe irritation grade for erythema, dryness, scaling, pruritus, stinging/burning, and edema

• Ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics

• A participant who had used a sauna during the 2 weeks prior to study entry and during the study

• Participants who had performed wax epilation of the face within 14 days prior to baseline

• A participant who had a history of being unresponsive to topical azelaic acid therapy

• A participant who had any clinically significant condition or situation, other than the condition being studied that, in the opinion of the Investigator, could have interfered with the study evaluations or optimal participation in the study

• A participant who had used any topical azelaic acid therapy within 30 days of baseline visit

• Participants who had participated in an investigational drug study (for example, participants had been treated with an investigational drug) within 30 days prior to baseline were excluded from study participation. Participants who were participating in non-treatment studies such as observational studies or registry studies could be considered for inclusion

• Participants who had been previously randomized in this study

• Participants who had laser therapy (for telangiectasia or other conditions) and phototherapy to the facial area within 180 days prior to study entry

• Participants who had cosmetic procedures (for example, facials), which could affect the efficacy and safety profile of the investigational product within 14 days prior to study entry

• Employees or staff of the research site were excluded from participation in the study

• No more than 1 participant from the same household was allowed to participate in the study

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• Generic Azelaic Acid Foam
Topical foam, generic formulation of the brand product.
• Finacea® (Azelaic Acid) Foam
Topical foam, brand product.
• Vehicle Foam
Topical foam, placebo. Has no active ingredient.

Other:
• Cleanser
A mild cleanser provided to participants, so they can wash their face prior to applying the study drug.
• Sunscreen
Sunscreen provided to participants, so they can apply it to their face when outdoors.
• Towel
A soft towel provided to participants, so they can pat their face dry after washing and prior to applying the study drug.
• Moisturizing Lotion
Moisturizing lotion provided to participants, so they can apply it to their face, as needed.

Locations

Country	Name	City	State
United States	Investigative Site 19	Brandon	Florida
United States	Investigative Site 3	Cincinnati	Ohio
United States	Investigative Site 4	Dallas	Texas
United States	Investigative Site 26	El Paso	Texas
United States	Investigative Site 2	Encino	California
United States	Investigative Site 1	Hialeah	Florida
United States	Investigative Site 9	Hialeah	Florida
United States	Investigative Site 8	High Point	North Carolina
United States	Investigative Site 10	La Mesa	California
United States	Investigative Site 23	Lauderdale Lakes	Florida
United States	Investigative Site 11	Miami	Florida
United States	Investigative Site 15	Miami	Florida
United States	Investigative Site 20	Miami	Florida
United States	Investigative Site 12	Miramar	Florida
United States	Investigative Site 7	New Braunfels	Texas
United States	Investigative Site 6	New Orleans	Louisiana
United States	Investigative Site 5	Norfolk	Virginia
United States	Investigative Site 25	Ocala	Florida
United States	Investigative Site 17	Omaha	Nebraska
United States	Investigative Site 22	Pembroke Pines	Florida
United States	Investigative Site 21	Philadelphia	Pennsylvania
United States	Investigative Site 14	Plainfield	Indiana
United States	Investigative Site 16	Savannah	Georgia
United States	Investigative Site 24	Spokane	Washington
United States	Investigative Site 18	Tampa	Florida
United States	Investigative Site 13	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Actavis Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12	All facial papules, pustules, and nodules, located above the jaw line and extending to the hairline, were counted. When counting facial lesions, lesions present on the nose were included. The total count for each lesion type was recorded and the total number of inflammatory lesions (papules and pustules) were calculated. A papule with a pustule on its apex was counted as a pustule. Counts of nodules and cysts were reported separately and not included in the inflammatory counts. Papule defined as inflammatory lesion; small (=5 mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule defined as inflammatory lesion; small (=5 mm in diameter), inflamed skin swelling that is filled with pus. Cyst and nodule defined as palpable solid or soft lesion >5 mm in diameter.	Baseline, 12 weeks
Secondary	Percentage of Participants With Treatment Success Based on IGE Score	Treatment success defined as an Investigator's Global Evaluation (IGE) score at Week 12 of 0 (clear) or 1 (almost clear). Any other outcome was considered a failure. Participants who were discontinued prematurely from the study due to lack of treatment effect after at least 8 weeks of compliant treatment were considered as treatment failures. The IGE score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).	Baseline and 12 Weeks