Fractional Carbon Dioxide Laser Versus UVA1 Phototherapy for Treatment of Localized Scleroderma: A Clinical & Immunohistochemical Comparative Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Localized Scleroderma
- Sponsor
- Cairo University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Evaluation of the efficacy of fractional carbon dioxide laser as a new method for treatment of localized scleroderma
- Last Updated
- 11 years ago
Overview
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 Description
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.
Investigators
Suzan Shalaby
Assisstant lecturer - Dermatology department - Faculty of medicine
Cairo University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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 .
Secondary Outcomes
- Assessing the degree of improvement of cases of localized scleroderma using each method(4 months)