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

May 13, 2010
December 11, 2012
May 2010
July 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01125930 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Atralin Gel for the Treatment of Rosacea
Investigation of the Topical Retinoid, Atralin Gel 0.05% for the Treatment of Erythematotelangiectatic Rosacea

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Rosacea
  • 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.
  • 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.
  • Placebo Comparator: Vehicle gel
    Intervention: Drug: vehicle gel
  • Active Comparator: Atralin gel
    Intervention: Drug: Atralin gel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
81
Not Provided
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01125930
Derm 616
No
University of Michigan
University of Michigan
Valeant Pharmaceuticals International, Inc.
Principal Investigator: Lisa E Maier, M.D. University of Michigan
University of Michigan
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP