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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractional carbon dioxide laser | Experimental | Single session of fractional laser is done using DEKA machine , for 3 months . |
|
| Ultraviolet A1 phototherapy (UVA1) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional carbon dioxide laser | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the complications of each type of therapy | check list for each of common complications of Laser therapy & photo therapy is done for each patient. | 4 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suzan M Shalaby, Ass.lecturer | Contact | 01224019459 | suzanshalaby@kasralainy.edu.eg | |
| Manal AW Bosseila, Professor | Contact | 01002412964 | manal.bosseila@kasralainy.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Suzan M Shalaby, Ass.lecturer | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University- Dermatology outpatient clinic | Recruiting | Cairo | 020 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22006130 | Background | Kineston D, Kwan JM, Uebelhoer NS, Shumaker PR. Use of a fractional ablative 10.6-mum carbon dioxide laser in the treatment of a morphea-related contracture. Arch Dermatol. 2011 Oct;147(10):1148-50. doi: 10.1001/archdermatol.2011.247. No abstract available. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 25, 2016 | |
| Reset | Feb 22, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 25, 2016 | Feb 22, 2016 |
| ID | Term |
|---|---|
| D012594 | Scleroderma, Localized |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| Ultraviolet A1 phototherapy (UVA1) | Device | 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. |
|