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

Information source: Actavis Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rosacea

Intervention: Azelaic acid (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Actavis Inc.

Official(s) and/or principal investigator(s):
John Capicchioni, Study Director, Affiliation: Akesis, LLC

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.

Clinical Details

Official title: A Multicenter, Double-blind, Randomized, Parallel-group, Vehicle-Controlled Study to Evaluate the Safety and Clinical Equivalence of a Generic Azelaic Acid Gel, 15% and the Reference Listed Finacea® (Azelaic Acid) Gel, 15% in Patients With Moderate Facial Rosacea.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The primary endpoint is the percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts.

Secondary outcome: The proportion of subjects with a clinical respsoense of "success" at Week 12 using Investigator Global Evaluation (IGE)

Detailed description: FINACEA® (azelaic acid) GEL, 15% contains azelaic acid, a naturally occurring saturated dicarboxylic acid that has proven anti-inflammatory effects, as well as anti-keratinizing and antimicrobial action, although its mechanism of action in rosacea is not well understood. This study will be conducted in compliance with the protocol, Good Clinical Practices (GCP) and the applicable regulatory requirement(s). Marketed by Intendis, Finacea® (azelaic acid) Gel, 15% is a safe and effective topical therapy used for the treatment of moderate facial rosacea. Watson Laboratories, Inc. has developed a generic formulation of azelaic acid 15% gel and the current study is designed to evaluate the safety and efficacy of this formulation.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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. Exclusion Criteria:

- 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:

1. topical retinoids to the face; 2. 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); 3. 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:

1. topical corticosteroids; 2. topical antibiotics; 3. topical medications for rosacea (e. g., metronidazole).

- Patients with moderate or severe rhinophyma, dense telangiectases (score 3, severe),

or plaque-like facial edema.

- Patients with a severe irritation grade for erythema, dryness, scaling, pruritus,

stinging/burning, and edema.

- Ocular rosacea (e. g., conjunctivitis, blepharitis, or keratitis) of sufficient

severity to require topical or systemic antibiotics.

- A patient who has used a sauna during the 2 weeks prior to study entry and during the

study.

- Patients who have performed wax epilation of the face within 14 days prior to

baseline

- A patient who has a history of being unresponsive to topical azelaic acid therapy.

- A patient with bacterial folliculitis.

- A patient who consumes excessive alcohol, abuses licit or illicit drugs, or has a

condition that could compromise the patient's ability to comply with study requirements.

- Patients who engage in activities that involve excessive or prolonged exposure to

sunlight or weather extremes, such as wind or cold.

- A patient who has any clinically significant condition or situation, other than the

condition being studied that, in the opinion of the Investigator, would interfere with the study evaluations or optimal participation in the study.

- A patient who has used any topical azelaic acid therapy within 30 days of baseline

visit.

- Patients who have participated in an investigational drug study (i. e., patients have

been treated with an Investigational Drug) within 30 days prior to baseline will be excluded from study participation. Patients who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion.

- Patients who have been previously enrolled in this study.

- Patients who have had laser therapy (for telangiectasia or other conditions),

electrodessication and phototherapy (e. g., ClearLight®) to the facial area within 180 days prior to study entry.

- Patients who have had cosmetic procedures (e. g., facials) which may affect the

efficacy and safety profile of the Investigational Product within 14 days prior to study entry.

Locations and Contacts

Site 24, Freemont, California, United States

Site 22, Santa Monica, California, United States

Site 1, Brandon, Florida, United States

Site 3, Fort Myers, Florida, United States

Site 27, Jacksonville, Florida, United States

Site 19, Miami, Florida, United States

Site 9, Miami, Florida, United States

Site 29, Miramar, Florida, United States

Site 2, Tampa, Florida, United States

Site 15, Chicago, Illinois, United States

Site 4, Plainfield, Indiana, United States

Site 14, Lake Charles, Louisiana, United States

Site 17, Glenn Dale, Maryland, United States

Site 6, Bay City, Michigan, United States

Site 30, Clinton Twp, Michigan, United States

Site 16, Las Vegas, Nevada, United States

Site 11, Raleigh, North Carolina, United States

Site 23, Winstron Salem, North Carolina, United States

Site 26, Philadelphia, Pennsylvania, United States

Site 12, Warwick, Rhode Island, United States

Site 28, Simpsonville, South Carolina, United States

Site 20, Nashville, Tennessee, United States

Site 21, College Station, Texas, United States

Site 5, Dallas, Texas, United States

Site 8, El Paso, Texas, United States

Site 13, Houston, Texas, United States

Site 7, Katy, Texas, United States

Site 18, Salt Lake City, Utah, United States

Site 10, Norfolk, Virginia, United States

Site 25, University Place, Virginia, United States

Additional Information

Starting date: July 2013
Last updated: July 8, 2015

Page last updated: August 20, 2015

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