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

NCT03287791 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ACTA/AZEL/2015
• Study Type: interventional
• Target: 924
• Locations: 1 country
• Sites: 26

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.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Participants With Treatment Success Based on IGE Score

  Baseline and 12 Weeks

Study Arms (3)

Generic Azelaic Acid Foam

EXPERIMENTAL

A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.

Drug: Generic Azelaic Acid Foam; Other: Cleanser; Other: Sunscreen; Other: Towel; Other: Moisturizing Lotion

Finacea® (Azelaic Acid) Foam

ACTIVE COMPARATOR

A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.

Drug: Finacea® (Azelaic Acid) Foam; Other: Cleanser; Other: Sunscreen; Other: Towel; Other: Moisturizing Lotion

Vehicle Foam

PLACEBO COMPARATOR

A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.

Drug: Vehicle Foam; Other: Cleanser; Other: Sunscreen; Other: Towel; Other: Moisturizing Lotion

Interventions

Generic Azelaic Acid Foam DRUG

Topical foam, generic formulation of the brand product.

Generic Azelaic Acid Foam

Finacea® (Azelaic Acid) Foam DRUG

Topical foam, brand product.

Finacea® (Azelaic Acid) Foam

Vehicle Foam DRUG

Topical foam, placebo. Has no active ingredient.

Vehicle Foam

Cleanser OTHER

A mild cleanser provided to participants, so they can wash their face prior to applying the study drug.

Finacea® (Azelaic Acid) Foam; Generic Azelaic Acid Foam; Vehicle Foam

Sunscreen OTHER

Sunscreen provided to participants, so they can apply it to their face when outdoors.

Finacea® (Azelaic Acid) Foam; Generic Azelaic Acid Foam; Vehicle Foam

Towel OTHER

A soft towel provided to participants, so they can pat their face dry after washing and prior to applying the study drug.

Finacea® (Azelaic Acid) Foam; Generic Azelaic Acid Foam; Vehicle Foam

Moisturizing Lotion OTHER

Moisturizing lotion provided to participants, so they can apply it to their face, as needed.

Finacea® (Azelaic Acid) Foam; Generic Azelaic Acid Foam; Vehicle Foam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (26)

Investigative Site 2

Encino, California, United States

Location

Investigative Site 10

La Mesa, California, United States

Location

Investigative Site 19

Brandon, Florida, United States

Location

Investigative Site 1

Hialeah, Florida, United States

Location

Investigative Site 9

Hialeah, Florida, United States

Location

Investigative Site 23

Lauderdale Lakes, Florida, United States

Location

Investigative Site 11

Miami, Florida, United States

Location

Investigative Site 15

Miami, Florida, United States

Location

Investigative Site 20

Miami, Florida, United States

Location

Investigative Site 12

Miramar, Florida, United States

Location

Investigative Site 25

Ocala, Florida, United States

Location

Investigative Site 22

Pembroke Pines, Florida, United States

Location

Investigative Site 18

Tampa, Florida, United States

Location

Investigative Site 16

Savannah, Georgia, United States

Location

Investigative Site 14

Plainfield, Indiana, United States

Location

Investigative Site 13

Wichita, Kansas, United States

Location

Investigative Site 6

New Orleans, Louisiana, United States

Location

Investigative Site 17

Omaha, Nebraska, United States

Location

Investigative Site 8

High Point, North Carolina, United States

Location

Investigative Site 3

Cincinnati, Ohio, United States

Location

Investigative Site 21

Philadelphia, Pennsylvania, United States

Location

Investigative Site 4

Dallas, Texas, United States

Location

Investigative Site 26

El Paso, Texas, United States

Location

Investigative Site 7

New Braunfels, Texas, United States

Location

Investigative Site 5

Norfolk, Virginia, United States

Location

Investigative Site 24

Spokane, Washington, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

azelaic acid; Sunscreening Agents

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Results Point of Contact

• Title: Director, CE Studies
• Organization: Teva Pharmaceuticals Inc. USA

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Study Director

  Teva Pharmaceuticals USA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 19, 2017
• Study Start: July 19, 2016
• Primary Completion: June 22, 2017
• Study Completion: June 22, 2017
• Last Updated: July 31, 2019
• Results First Posted: July 17, 2019

Record last verified: 2019-07

Locations

US (26)