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Randomized, Double-blind, Multiple-site, Placebo-controlled, Parallel-design Study in Patients With Moderate to Severe Facial Erythema Associated With Rosacea

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ClinicalTrials.gov Identifier: NCT02289352
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : March 19, 2015
Sponsor:
Collaborator:
Watson Laboratories, Inc.
Information provided by (Responsible Party):
Actavis Inc.

Brief Summary:
A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson Laboratories, Inc., USA) to Reference Product Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) in Patients with Moderate to Severe Facial Erythema Associated with Rosacea

Condition or disease Intervention/treatment Phase
Rosacea Drug: Brimonidine Drug: placebo Phase 3

Detailed Description:
Up to 462 patients 18 years of age and older, with confirmed clinical diagnosis of rosacea will be enrolled to have 413 in the modified intent-to-treat (mITT) population and 371 in the per-protocol (PP) population. Patients should have fewer than 3 facial inflammatory lesions, and moderate to severe erythema according to both Clinician's Erythema Assessment (CEA) and Patient's Self-Assessment (PSA).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson Laboratories, Inc., USA) to Reference Product Mirvaso® (Brimonidine) Topical Gel, 0.33% (Galderma Laboratories, L.P., USA) in Patients With Moderate to Severe Facial Erythema Associated With Rosacea
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: brimonidine 0.33% gel
Brimonidine Topical Gel, 0.33%, 30 gram fill (Watson Laboratories, Inc., USA)
Drug: Brimonidine
Active Comparator: Mirvaso gel
Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA)
Drug: Brimonidine
Placebo Comparator: Placebo
Topical gel base only (Watson Laboratories Inc., USA)
Drug: placebo



Primary Outcome Measures :
  1. rosacea improvement or treatment success [ Time Frame: 7 days ]
    Proportion of patients with a clinical response of treatment success on Day 7 (± 1). Treatment success is defined as at least a 2-grade improvement on both CEA and PSA scores from baseline (pre-dose) on Day 7 (± 1) to 6 hours post-application on Day 7 (± 1).


Secondary Outcome Measures :
  1. Proportion of patients with a clinical response of treatment success on Day 1 [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or non-pregnant, non-lactating female, 18 years of age or older.
  2. Signed informed consent form, which meets all criteria of current FDA regulations.
  3. Females of child bearing potential must not be pregnant or lactating at Screening and Randomization (as confirmed by a negative urine pregnancy test with a sensitivity of less than 25 mlU/mL or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, IUD, a double-barrier method [such as condom plus diaphragm with spermicide], oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study. A sterile sexual partner is not considered an adequate form of birth control.

    All females will be considered to be of childbearing potential unless they:

    • Are post-menopausal, defined as women who have been amenorrheic for at least 12 consecutive months, without other known or suspected primary cause.
    • Have been sterilized surgically or who are otherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy) with surgery at least 4 weeks prior to Screening. Tubal ligation will not be considered a surgically sterile method.

    Female patients of childbearing potential are defined as:

    • Women without prior hysterectomy, or who have had any evidence of menses in the past 12 months.
    • Females who have been amenorrhea for ≥ 12 months, but the amenorrhea is possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression.
  4. Have a clinical diagnosis of facial rosacea and fewer than 3 inflammatory lesions on the face at Screening and at Randomization (before drug application on Day 1).
  5. Have moderate to severe facial erythema according to both CEA and PSA (i.e., an erythema score of 3 or more for each of the CEA and PSA) at Screening and at Randomization (before drug application on Day 1).
  6. Free from any systemic or dermatologic disorder (other than rosacea) that, in the opinion of the Investigator, will interfere with the study evaluations or increase the risk of AEs.
  7. Willing to minimize external factors that might trigger rosacea flare-ups (e.g., hot environments, prolonged sun exposure, strong winds and emotional stress) within 24 hours of the Screening and Randomization visit.
  8. Any skin type or race, providing the skin pigmentation will allow discernment of erythema.
  9. Willingness and capability to cooperate to the extent and degree required by the protocol.

Exclusion Criteria:

  1. Patients with particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses similar to rosacea, such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia, that are present on the face (i.e., 5 areas: chin, nose, both cheeks, and forehead), that in the opinion of the Investigator would interfere with study evaluations.
  2. Have 3 or more facial inflammatory lesions of rosacea.
  3. Have an erythema score of 2 (mild), 1 (almost clear), or 0 (clear) on the CEA and/or the PSA at Screening and at Randomization (before drug application on Day 1).
  4. Patients with excessive facial hair (beards, sideburns, mustaches, etc.) that would interfere with the diagnosis or assessment of rosacea.
  5. Patients with moderate to severe telangiectasial masses in the 5 areas of the entire face: forehead, chin, nose and each cheek, that would interfere with study evaluations.
  6. History of hypersensitivity or allergy to Mirvaso® including the active ingredient brimonidine tartarate or other component within the formulation.
  7. Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization.
  8. Exposed to excessive ultraviolet (UV) radiation within 1 week before screening or randomization visit and/or patient was unwilling to refrain from excessive exposure to UV radiation during the course of the study.
  9. History of blood dyscrasia.
  10. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression, or any other condition causing uncontrolled blood flow or blood pressure.
  11. Females who are pregnant, lactating or likely to become pregnant during the study.
  12. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation.
  13. Patients with severe, unstable or uncontrolled cardiovascular disease.
  14. Patients who meet study restrictions at Screening and Randomization and/or unwillingness to comply with all restricted treatments
  15. Receipt of any drug as part of a research study within 30 days before dosing.
  16. Employees of the research center or Investigator.
  17. Previous participation in this study.
  18. Patients who are unable and/or unwilling to follow the study requirements, and procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289352


Locations
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United States, Arkansas
Investigator site 2
Hot Springs, Arkansas, United States, 71913
United States, California
Investigator site 16
Long Beach, California, United States, 90813
United States, Florida
Investigator site 5
Miami, Florida, United States, 33015
Investigator site 7
Miami, Florida, United States, 33175
Investigator site 8
Miramar, Florida, United States, 33027
Investigator site 6
Ormond Beach, Florida, United States, 32174
United States, Indiana
Investigator site 3
Carmel, Indiana, United States, 46032
United States, Kentucky
Investigator site 9
Louisville, Kentucky, United States, 40202
United States, Minnesota
Investigator site 14
Fridley, Minnesota, United States, 55432
United States, Nevada
Investigator site 15
Henderson, Nevada, United States, 89052
United States, New Mexico
Investigator site 1
Albuquerque, New Mexico, United States, 87106
United States, North Carolina
Investigator site 10
High Point, North Carolina, United States, 27262
United States, Ohio
Investigator site 11
Beachwood, Ohio, United States, 44122
United States, Tennessee
Investigator site 4
Nashville, Tennessee, United States, 37215
United States, Texas
Investigator site 13
College Station, Texas, United States, 77845
Investigator site 12
Houston, Texas, United States, 77055
Sponsors and Collaborators
Actavis Inc.
Watson Laboratories, Inc.
Investigators
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Study Director: Nageshwar R Thudi, Ph.D. Actavis Inc.

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Responsible Party: Actavis Inc.
ClinicalTrials.gov Identifier: NCT02289352     History of Changes
Other Study ID Numbers: 71304906
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Brimonidine Tartrate
Rosacea
Erythema
Skin Diseases
Skin Manifestations
Signs and Symptoms
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs