Clinical trial NCT02002897: Fractional Carbon Dioxide Laser Versus UVA 1 in Treatment of Localized Scleroderma
Official title: Fractional Carbon Dioxide Laser Versus UVA1 Phototherapy for Treatment of Localized Scleroderma: A Clinical & Immunohistochemical Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Localized Scleroderma
Keywords: Localized scleroderma UVA1 fractional carbon dioxide laser
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the efficacy of fractional carbon dioxide laser as a new method for treatment of localized scleroderma
timeFrame: 4 months
Secondary outcomes:
measure: Assessing the degree of improvement of cases of localized scleroderma using each method
timeFrame: 4 months
Other outcomes:
measure: Assessing the complications of each type of therapy
timeFrame: 4 months
Locations:
city: Cairo
country: Egypt
facility: Cairo University- Dermatology outpatient clinic
Study officials:
affiliation: Cairo University
name: Suzan M Shalaby, Ass.lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.