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

Completed · Phase 3 · Has a placebo group

Conditions studied: Rosacea

In brief

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.

Key facts

Study ID

NCT03287791

Run by

Actavis Inc.

People needed

924

Starts

2016-07-19

Expected to finish

2017-06-22

Last updated by the study team

2019-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigative Site 2 — Encino, California, United States
• Investigative Site 10 — La Mesa, California, United States
• Investigative Site 19 — Brandon, Florida, United States
• Investigative Site 1 — Hialeah, Florida, United States
• Investigative Site 9 — Hialeah, Florida, 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 25 — Ocala, Florida, United States
• Investigative Site 22 — Pembroke Pines, Florida, United States
• Investigative Site 18 — Tampa, Florida, United States
• Investigative Site 16 — Savannah, Georgia, United States
• Investigative Site 14 — Plainfield, Indiana, United States
• Investigative Site 13 — Wichita, Kansas, United States
• Investigative Site 6 — New Orleans, Louisiana, United States
• Investigative Site 17 — Omaha, Nebraska, United States
• Investigative Site 8 — High Point, North Carolina, United States
• Investigative Site 3 — Cincinnati, Ohio, United States
• Investigative Site 21 — Philadelphia, Pennsylvania, United States
• Investigative Site 4 — Dallas, Texas, United States
• Investigative Site 26 — El Paso, Texas, United States
• Investigative Site 7 — New Braunfels, Texas, United States
• Investigative Site 5 — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.