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

July 18, 2019 updated by: Actavis Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
924

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encino, California, United States
        • Investigative Site 2
      • La Mesa, California, United States
        • Investigative Site 10
    • Florida
      • Brandon, Florida, United States
        • Investigative Site 19
      • Hialeah, Florida, United States
        • Investigative Site 1
      • Hialeah, Florida, United States
        • Investigative Site 9
      • Lauderdale Lakes, Florida, United States
        • Investigative Site 23
      • Miami, Florida, United States
        • Investigative Site 11
      • Miami, Florida, United States
        • Investigative Site 15
      • Miami, Florida, United States
        • Investigative Site 20
      • Miramar, Florida, United States
        • Investigative Site 12
      • Ocala, Florida, United States
        • Investigative Site 25
      • Pembroke Pines, Florida, United States
        • Investigative Site 22
      • Tampa, Florida, United States
        • Investigative Site 18
    • Georgia
      • Savannah, Georgia, United States
        • Investigative Site 16
    • Indiana
      • Plainfield, Indiana, United States
        • Investigative Site 14
    • Kansas
      • Wichita, Kansas, United States
        • Investigative Site 13
    • Louisiana
      • New Orleans, Louisiana, United States
        • Investigative Site 6
    • Nebraska
      • Omaha, Nebraska, United States
        • Investigative Site 17
    • North Carolina
      • High Point, North Carolina, United States
        • Investigative Site 8
    • Ohio
      • Cincinnati, Ohio, United States
        • Investigative Site 3
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Investigative Site 21
    • Texas
      • Dallas, Texas, United States
        • Investigative Site 4
      • El Paso, Texas, United States
        • Investigative Site 26
      • New Braunfels, Texas, United States
        • Investigative Site 7
    • Virginia
      • Norfolk, Virginia, United States
        • Investigative Site 5
    • Washington
      • Spokane, Washington, United States
        • Investigative Site 24

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Generic Azelaic Acid Foam
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
Topical foam, generic formulation of the brand product.
Other: Cleanser
A mild cleanser provided to participants, so they can wash their face prior to applying the study drug.
Other: Sunscreen
Sunscreen provided to participants, so they can apply it to their face when outdoors.
Other: Towel
A soft towel provided to participants, so they can pat their face dry after washing and prior to applying the study drug.
Other: Moisturizing Lotion
Moisturizing lotion provided to participants, so they can apply it to their face, as needed.
Active Comparator: Finacea® (Azelaic Acid) Foam
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.
Other: Cleanser
A mild cleanser provided to participants, so they can wash their face prior to applying the study drug.
Other: Sunscreen
Sunscreen provided to participants, so they can apply it to their face when outdoors.
Other: Towel
A soft towel provided to participants, so they can pat their face dry after washing and prior to applying the study drug.
Other: Moisturizing Lotion
Moisturizing lotion provided to participants, so they can apply it to their face, as needed.
Drug: Finacea® (Azelaic Acid) Foam
Topical foam, brand product.
Placebo Comparator: Vehicle Foam
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.
Other: Cleanser
A mild cleanser provided to participants, so they can wash their face prior to applying the study drug.
Other: Sunscreen
Sunscreen provided to participants, so they can apply it to their face when outdoors.
Other: Towel
A soft towel provided to participants, so they can pat their face dry after washing and prior to applying the study drug.
Other: Moisturizing Lotion
Moisturizing lotion provided to participants, so they can apply it to their face, as needed.
Drug: Vehicle Foam
Topical foam, placebo. Has no active ingredient.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12
Time Frame: Baseline, 12 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Treatment Success Based on IGE Score
Time Frame: Baseline and 12 Weeks
Treatment success defined as an Investigator's Global Evaluation (IGE) score at Week 12 of 0 (clear) or 1 (almost clear). Any other outcome was considered a failure. Participants who were discontinued prematurely from the study due to lack of treatment effect after at least 8 weeks of compliant treatment were considered as treatment failures. The IGE score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
Baseline and 12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actavis Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Teva Pharmaceuticals USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACTA/AZEL/2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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