Atralin Gel for the Treatment of Rosacea

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
University of Michigan
ClinicalTrials.gov Identifier:
NCT01125930
First received: May 13, 2010
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

Erythematotelangiectatic rosacea is a type of rosacea that causes a red face often with frequent flushing, topical sensitivity and prominent blood vessels. We think that long term damage to skin from the sun (photodamage) may play a role in causing this type of rosacea. Tretinoin is a topical medication that is known to improve photodamage. We want to find out if Atralin (tretinoin 0.05%) Gel used for up to 46 weeks will improve erythematotelangiectatic rosacea (ETR).


Condition Intervention Phase
Rosacea
Drug: vehicle gel
Drug: Atralin gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of the Topical Retinoid, Atralin Gel 0.05% for the Treatment of Erythematotelangiectatic Rosacea

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Severity of erythematotelangiectatic rosacea signs [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Severity of erythematotelagiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin

  • Severity of erythematotelangiectatic rosacea symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 2, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]
  • Photodamage [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Signs of other rosacea subtypes [ Time Frame: 2, 6, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
    ocular, phymatous or papulopustular manifestations of rosacea

  • Molecular markers of inflammation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    These will be evaluated from skin biopsy from some subjects at baseline and final evaluation at 24 weeks.

  • Molecular evidence of photodamage [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    These will be evaluated from skin biopsy from some subjects at baseline and final evaluation at 24 weeks.

  • Severity of erythematotelangiectatic signs [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: No ]
  • Severity of erythematotelangiectatic rosacea symptoms [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: No ]
  • Skin irritation [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 81
Study Start Date: May 2010
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vehicle gel Drug: vehicle gel
Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Active Comparator: Atralin gel Drug: Atralin gel
Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects 18 years of age and older of any race.
  2. Clinical diagnosis of mild to moderate erythematotelangiectatic facial rosacea based on physician evaluation.
  3. Willing and able to understand and sign informed consent.
  4. Able to complete study and comply with study procedures.

Exclusion Criteria:

  1. Severe self reported facial sensitivity
  2. History of allergy to fish
  3. Severe sun sensitivity
  4. Severe erythematotelangiectatic rosacea requiring systemic treatment
  5. Papulopustular, Ocular-only, Phymatous rosacea, Steroid rosacea, pyoderma faciale
  6. Unwilling to undergo facial biopsies
  7. Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids
  8. Use of topical rosacea treatments in the past 2 weeks.
  9. Use of systemic antibiotics in the past 4 weeks.
  10. Use of systemic retinoids within the past 6 months.
  11. Use of topical retinoids within the past 3 months
  12. Use of laser or light based rosacea treatments within the past 2 months.
  13. Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within the past two months
  14. Use of topical anti-aging medications including alpha hydroxy acids, salicylic acid, beta-hydroxy acid, vitamin A, vitamin E, ascorbic acid
  15. Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments.
  16. Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
  17. If female, Subjects who are either of non-child bearing potential (defined as postmenopausal -absence of menstrual bleeding for 1 year - or as having undergone bilateral tubal ligation, hysterectomy or bilateral ovariectomy) or, if of childbearing potential, Subjects who have had a negative urine pregnancy test at the beginning of the study, and have agreed to practice appropriate birth-control to prevent pregnancy during the study.(The type and dose of birth control must have been stable for at least 2 months prior to study entry and not be expected to change during the study).
  18. Subjects who are lactating.
  19. Use of any investigational therapy within the past 4 weeks.
  20. Known hypersensitivity or previous allergic reaction to retinoids
  21. Carcinoid, Pheochromocytoma or other systemic flushing causes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125930

Locations
United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Valeant Pharmaceuticals International, Inc.
Investigators
Principal Investigator: Lisa E Maier, M.D. University of Michigan
  More Information

Publications:
Responsible Party: University of Michigan
ClinicalTrials.gov Identifier: NCT01125930     History of Changes
Other Study ID Numbers: Derm 616
Study First Received: May 13, 2010
Last Updated: December 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
rosacea
tretinoin
atralin

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Tretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on April 23, 2014