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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2014

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

  • Device: Fractional carbon dioxide laser
    • 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.
  • Device: Ultraviolet 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.

Arms, Groups and Cohorts

  • Experimental: Fractional carbon dioxide laser
    • Single session of fractional laser is done using DEKA machine , for 3 months .
  • Active Comparator: Ultraviolet A1 phototherapy (UVA1)
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Assessing the degree of improvement of cases of localized scleroderma using each method
    • Time Frame: 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 .

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Suzan Shalaby, Assisstant lecturer – Dermatology department – Faculty of medicine – Cairo University
  • Overall Official(s)
    • Suzan M Shalaby, Ass.lecturer, Principal Investigator, Cairo University
  • Overall Contact(s)
    • Suzan M Shalaby, Ass.lecturer, 01224019459, suzanshalaby@kasralainy.edu.eg

References

Kineston D, Kwan JM, Uebelhoer NS, Shumaker PR. Use of a fractional ablative 10.6-μm 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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.