Clinical Trial: Atralin Gel for the Treatment of Rosacea

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Investigation of the Topical Retinoid, Atralin Gel 0.05% for the Treatment of Erythematotelangiectatic Rosacea

Brief Summary: 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).

Detailed Summary:
Sponsor: Lisa E. Maier

Current Primary Outcome:

  • Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) [ Time Frame: 24 weeks ]
    Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
  • Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia [ Time Frame: 24 weeks ]
    Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
  • Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema [ Time Frame: 24 weeks ]
    Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
  • Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin [ Time Frame: 24 weeks ]
    Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
  • Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing [ Time Frame: 24 weeks ]
    Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions "Do you have flushing?".
  • Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning [ Tim

    Original Primary Outcome:

    • Severity of erythematotelangiectatic rosacea signs [ Time Frame: 24 weeks ]
      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 ]
      Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance


    Current Secondary Outcome:

    • Quality of Life [ Time Frame: 2, 6, 12, 18, 24 weeks ]
      The Dermatology Life Quality Index (DLQI) questionnaire was given at each visit. It involves 10 questions that relate to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The total DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
    • Photodamage [ Time Frame: 24 weeks ]
      Photodamage was measured at baseline and Week 24 visits using the nine point Hamilton-Griffiths Photoaging Score categories. The categories were developed using photographs of subject representing grades of photodamge from none (0) to severe (8). A direct comparison is made between the subject and the photographic standards. If an exact match cannot be made, the interstandard scores (1, 3, 5, 7) are used.
    • Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea [ Time Frame: 2, 6, 12, 18 and 24 weeks ]
      Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea
    • Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea [ Time Frame: 2, 6, 12, 18 and 24 weeks ]
      Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea
    • Signs of Other Rosacea Subtypes: Papulopustular [ Time Frame: 2, 6, 12, 18, 24 weeks ]
      Signs of other rosacea subtypes includes papulopustular, inflammatory papule count
    • Molecular Markers of Inflammation [ Time Frame: 24 weeks ]
      These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of inflammation include Tachykinin 1 (TAC1), CXC Motif Receptor 4 (CXCR4), CXC Motif Ligand 12 (CXCL12), and Tumor Necrosis Factor Alpha (TNFa).
    • Molecular Evidence of Photodamage [ Time Frame: 24 weeks ]
      These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of photodamage include Collagen 1 (COL-1), Collagen 3 (COL-3), Matrix Metalloproteinase 1 (MMP1), Matrix Metalloproteinase 3 (MMP3), and Matrix Metalloproteinase 9 (MMP9).
    • Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) [ Time Frame: 2, 6, 12, 18 weeks ]
      Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
    • Severity of Erythematotelangiectatic Signs: Telangiectasia [ Time Frame: 2, 6, 12, 18 weeks ]
      Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
    • Severity of Erythematotelangiectatic Signs: Facial Edema [ Time Frame: 2, 6, 12, 18 weeks ]
      Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
    • Severity of Erythematotelangiectatic Signs: Dryness/Irritation [ Time Frame: 2, 6, 12, 18 weeks ]
      Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
    • Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing [ Time Frame: 2, 6, 12, 18 weeks ]
      Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
    • Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning [ Time Frame: 2, 6, 12, 18 weeks ]
      Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
    • Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging [ Time Frame: 2, 6, 12, 18 weeks ]
      Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
    • Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment [ Time Frame: 2, 6, 12, 18 weeks ]
      Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
    • Skin Irritation Assessed by Facial Stinging Upon Prod

      Original Secondary Outcome:

      • Quality of life [ Time Frame: 2, 6, 12, 18, 24 weeks ]
      • Photodamage [ Time Frame: 24 weeks ]
      • Signs of other rosacea subtypes [ Time Frame: 2, 6, 12, 18 and 24 weeks ]
        ocular, phymatous or papulopustular manifestations of rosacea
      • Molecular markers of inflammation [ Time Frame: 24 weeks ]
        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 ]
        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 ]
      • Severity of erythematotelangiectatic rosacea symptoms [ Time Frame: 2, 6, 12, 18 weeks ]
      • Skin irritation [ Time Frame: 2, 6, 12, 18 weeks ]


      Information By: University of Michigan

      Dates:
      Date Received: May 13, 2010
      Date Started: May 2010
      Date Completion:
      Last Updated: July 15, 2014
      Last Verified: July 2014