Localized Scleroderma Clinical Trial
Official title:
Fractional Carbon Dioxide Laser Versus UVA1 Phototherapy for Treatment of Localized Scleroderma: A Clinical & Immunohistochemical Comparative Study
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.
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 scoring will be chosen for the
treatment interventions.
1. Lesion number (1) will be subjected to: localized UVA1 phototherapy (340-400 nm),
low dose irradiation, at a rate of 3 sessions per week , total of 24 sessions with
full clinical evaluation and investigations before and after treatment and clinical
follow up one month after treatment.
2. Lesion number (2) will be subjected to: Fractional carbon dioxide laser (10,600
nm), a session once per month, total of 3 sessions with full clinical evaluation
and investigations before and one month after the last session of treatment.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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Early Phase 1 | |
| Completed |
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N/A |