A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea

NCT02120924 | Completed Phase 3 Results

• 1 other identifier: 13-1014
• Study Type: interventional
• Target: 1,009
• Locations: 1 country
• Sites: 30

Brief 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.

Conditions

Rosacea

Keywords

Moderate facial rosacea; Azelaic acid; Rosacea

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts.

  Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts in PP population.

  Baseline to Week 12

Secondary Outcomes (1)

• The Percentage of Subjects With a Clinical Response of "Success" at Week 12 Using Investigator Global Evaluation (IGE)

  Baseline to 12 weeks

Study Arms (3)

Finacea

ACTIVE COMPARATOR

Finacea® (azelaic acid) Gel, 15% (Intendis)

Drug: Finacea

Azelaic Acid

EXPERIMENTAL

Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)

Drug: Azelaic acid

Vehicle Gel

PLACEBO COMPARATOR

Gel Vehicle of the test product (Watson Laboratories, Inc.)

Drug: Vehicle

Interventions

Azelaic acid DRUG

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.

Also known as: Generic

Azelaic Acid

Vehicle DRUG

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.

Also known as: Placebo

Vehicle Gel

Finacea DRUG

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.

Also known as: Finacea® (azelaic acid) Gel, 15% (Intendis)

Finacea

Eligibility Criteria

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

You may qualify if:

• 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.

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 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:
• topical retinoids to the face;
• 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);
• 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:
• topical corticosteroids;
• topical antibiotics;
• topical medications for rosacea (e.g., metronidazole).
• Patients with moderate or severe rhinophyma, dense telangiectases (score 3, severe), or plaque-like facial edema.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (30)

Site 24

Fremont, California, United States

Location

Site 22

Santa Monica, California, United States

Location

Site 1

Brandon, Florida, United States

Location

Site 3

Fort Myers, Florida, United States

Location

Site 27

Jacksonville, Florida, United States

Location

Site 19

Miami, Florida, United States

Location

Site 9

Miami, Florida, United States

Location

Site 29

Miramar, Florida, United States

Location

Site 2

Tampa, Florida, United States

Location

Site 15

Chicago, Illinois, United States

Location

Site 4

Plainfield, Indiana, United States

Location

Site 14

Lake Charles, Louisiana, United States

Location

Site 17

Glenn Dale, Maryland, United States

Location

Site 6

Bay City, Michigan, United States

Location

Site 30

Clinton Township, Michigan, United States

Location

Site 16

Las Vegas, Nevada, United States

Location

Site 11

Raleigh, North Carolina, United States

Location

Site 23

Winston-Salem, North Carolina, United States

Location

Site 26

Philadelphia, Pennsylvania, United States

Location

Site 12

Warwick, Rhode Island, United States

Location

Site 28

Simpsonville, South Carolina, United States

Location

Site 20

Nashville, Tennessee, United States

Location

Site 21

College Station, Texas, United States

Location

Site 5

Dallas, Texas, United States

Location

Site 8

El Paso, Texas, United States

Location

Site 13

Houston, Texas, United States

Location

Site 7

Katy, Texas, United States

Location

Site 18

Salt Lake City, Utah, United States

Location

Site 10

Norfolk, Virginia, United States

Location

Site 25

University Place, Virginia, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

azelaic acid; Drugs, Generic; Gels

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Colloids; Complex Mixtures; Dosage Forms

Results Point of Contact

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

USMedinfo@tevapharm.com

1-888-483-8279

Study Officials

• John Capicchioni

  Akesis, LLC

  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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: April 23, 2014
• Study Start: July 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 2, 2020
• Results First Posted: June 2, 2020

Record last verified: 2020-05

Locations

US (30)