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

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

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

Conditions
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Localized Scleroderma

Intervention / Treatment
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* Device: Fractional carbon dioxide laser
* Device: Ultraviolet A1 phototherapy (UVA1)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Types of morphea: plaque, linear and atrophic. Patients are either new or discontinued systemic treatment for at least two months Exclusion Criteria: Morphea profunda and systemic scleroderma (diagnosed by: Rayaund's Phenomenon and sclerodactyly +/- internal organ affection) Contraindications to phototherapy: eg: photosensitivity, systemic lupus, melanoma, skin cancer, or porphyria. Contraindications to laser: Use of systemic retinoids in the last 6 months.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fractional carbon dioxide laser<br>Single session of fractional laser is done using DEKA machine , for 3 months . | Device: Fractional carbon dioxide laser<br>* 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.<br>|
| Active Comparator: Ultraviolet A1 phototherapy (UVA1)<br>24 sessions of UVA 1 phototherapy are give at a rate of 3 sessions per week , at a dose of 30 joules using a Waldman targeted machine. | Device: Ultraviolet A1 phototherapy (UVA1)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the efficacy of fractional carbon dioxide laser as a new method for treatment of localized scleroderma | 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 . | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the degree of improvement of cases of localized scleroderma using each method | 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 . | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Localized scleroderma UVA1 fractional carbon dioxide laser