Clinical trial NCT03287791: A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rosacea
Lead sponsor: Actavis Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-19
Enrollment: 924
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Percentage of Participants With Treatment Success Based on IGE Score
timeFrame: Baseline and 12 Weeks
Other outcomes:
Locations:
city: Encino
country: United States
facility: Investigative Site 2
state: California
city: La Mesa
country: United States
facility: Investigative Site 10
state: California
city: Brandon
country: United States
facility: Investigative Site 19
state: Florida
city: Hialeah
country: United States
facility: Investigative Site 1
state: Florida
city: Hialeah
country: United States
facility: Investigative Site 9
state: Florida
city: Lauderdale Lakes
country: United States
facility: Investigative Site 23
state: Florida
city: Miami
country: United States
facility: Investigative Site 11
state: Florida
city: Miami
country: United States
facility: Investigative Site 15
state: Florida
city: Miami
country: United States
facility: Investigative Site 20
state: Florida
city: Miramar
country: United States
facility: Investigative Site 12
state: Florida
city: Ocala
country: United States
facility: Investigative Site 25
state: Florida
city: Pembroke Pines
country: United States
facility: Investigative Site 22
state: Florida
city: Tampa
country: United States
facility: Investigative Site 18
state: Florida
city: Savannah
country: United States
facility: Investigative Site 16
state: Georgia
city: Plainfield
country: United States
facility: Investigative Site 14
state: Indiana
city: Wichita
country: United States
facility: Investigative Site 13
state: Kansas
city: New Orleans
country: United States
facility: Investigative Site 6
state: Louisiana
city: Omaha
country: United States
facility: Investigative Site 17
state: Nebraska
city: High Point
country: United States
facility: Investigative Site 8
state: North Carolina
city: Cincinnati
country: United States
facility: Investigative Site 3
state: Ohio
city: Philadelphia
country: United States
facility: Investigative Site 21
state: Pennsylvania
city: Dallas
country: United States
facility: Investigative Site 4
state: Texas
city: El Paso
country: United States
facility: Investigative Site 26
state: Texas
city: New Braunfels
country: United States
facility: Investigative Site 7
state: Texas
city: Norfolk
country: United States
facility: Investigative Site 5
state: Virginia
city: Spokane
country: United States
facility: Investigative Site 24
state: Washington
Study officials:
affiliation: Teva Pharmaceuticals USA
name: Study Director
role: STUDY_DIRECTOR
References: