Localized Scleroderma
Conditions
Keywords
Localized scleroderma UVA1 fractional carbon dioxide laser
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.
Interventions
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.
DEVICEUltraviolet A1 phototherapy (UVA1)
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Types of morphea: plaque, linear and atrophic. 2. Patients are either new or discontinued systemic treatment for at least two months
Exclusion criteria
1. Morphea profunda and systemic scleroderma (diagnosed by: Rayaund's Phenomenon and sclerodactyly +/- internal organ affection) 2. Contraindications to phototherapy: eg: photosensitivity, systemic lupus, melanoma, skin cancer, or porphyria. 3. Contraindications to laser: Use of systemic retinoids in the last 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the efficacy of fractional carbon dioxide laser as a new method for treatment of localized scleroderma | 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
| Measure | Time frame | Description |
|---|---|---|
| Assessing the degree of improvement of cases of localized scleroderma using each method | 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 . |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessing the complications of each type of therapy | 4 months | check list for each of common complications of Laser therapy & photo therapy is done for each patient. |
Countries
Egypt
Contacts
Primary ContactSuzan M Shalaby, Ass.lecturer
Backup ContactManal AW Bosseila, Professor
Outcome results
None listed