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

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

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.

Study Overview

• Status: Unknown
• Conditions: Localized Scleroderma
• Intervention / Treatment: Device: Fractional carbon dioxide laser; Device: Ultraviolet A1 phototherapy (UVA1)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 020
    • Recruiting
    • Cairo University- Dermatology outpatient clinic
    • Contact: Suzan M Shalaby, Ass.lecturer; Phone Number: 01224019459; Email: suzanshalaby@kasralainy.edu.eg
    • Contact: Manal AW Bosseila, Professor; Phone Number: 01002412964; Email: manal.bosseila@kasralainy.edu.eg
    • Principal Investigator: Suzan M Shalaby, Ass.lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fractional carbon dioxide laser; Single session of fractional laser is done using DEKA machine , for 3 months .	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Suzan M Shalaby, Ass.lecturer, Cairo University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): November 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: September 5, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Estimate): September 11, 2014
• Last Update Submitted That Met QC Criteria: September 9, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Localized scleroderma UVA1 fractional carbon dioxide laser
• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
• Other Study ID Numbers: DDCU-24684