Clinical Trial: Fractional Carbon Dioxide Laser Versus UVA 1 in Treatment of Localized Scleroderma

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Fractional Carbon Dioxide Laser Versus UVA1 Phototherapy for Treatment of Localized Scleroderma: A Clinical & Immunohistochemical Comparative Study

Brief Summary: The study aims at evaluating the efficacy of the fractional carbon dioxide laser as a new modality for treatment of localized scleroderma and to compare its results with the well established method of UVA 1 phototherapy.

Detailed Summary:

The study includes 20 Cases presenting with one or more lesions of morphea (plaque, linear and atrophic). Each case will be subjected to:

  1. -Informed consent. 2-Detailed history 3- Clinical examination to assess type, site, extent. 4-Clinical evaluation before treatment, in the follow up period and after treatment ( 24 sessions of UVA1) (one month after last CO2 laser session) using a scoring system:

    • Skin thickness: 0-3, 0: normal; 1: thickened skin; 2: decreased ability to move the skin; 3: unable to pinch or move skin (according to the Modified Rodnan skin score)
    • Dermal atrophy: 0-3, 0: none, 1: shiny, 2: visible vessels, 3: obvious atrophy

    • Dyspigmentation (Hypo or hyper pigmentation): 0-3, 0: none, 1: mild, 2: moderate ,3: marked C- Digital Photography before, follow up and after treatment using the same digital camera , at fixed distance and constant settings for standardization .

      5-Investigations: A- Punch biopsy: A punch biopsy will be taken before and after treatment to be stained with haematoxylin and eosin.

B-Immunohistochemical assessment of

  • MMP1 (matrix metalloproteinase 1) in the pre and post treatment skin biopsies.

  • TGFß ( transforming growth factor beta)in the pre and post treatment skin biopsies.

    6-Treatment intervention: Two lesions with identical s
    Sponsor: Cairo University

    Current Primary Outcome: Evaluation of the efficacy of fractional carbon dioxide laser as a new method for treatment of localized scleroderma [ Time Frame: 4 months ]

    Efficacy will be evaluated by clinical assessment by blinded physician , biopsy before and after treatment for collagen assessment , Ultrasound bio-microscopy before and after treatment and patient satisfaction scores .


    Original Primary Outcome: Same as current

    Current Secondary Outcome: Assessing the degree of improvement of cases of localized scleroderma using each method [ Time Frame: 4 months ]

    Improvement will be evaluated by clinical assessment by blinded physician , biopsy before and after treatment for collagen assessment , Ultrasound bio-microscopy before and after treatment and patient satisfaction scores .


    Original Secondary Outcome: Same as current

    Information By: Cairo University

    Dates:
    Date Received: September 5, 2013
    Date Started: April 2013
    Date Completion: December 2014
    Last Updated: September 9, 2014
    Last Verified: September 2014