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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Cairo University
Sponsor:
Information provided by (Responsible Party):
Suzan Shalaby, Cairo University
ClinicalTrials.gov Identifier:
NCT02002897
First received: September 5, 2013
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Localized Scleroderma
Device: Fractional carbon dioxide laser
Device: Ultraviolet A1 phototherapy (UVA1)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fractional Carbon Dioxide Laser Versus UVA1 Phototherapy for Treatment of Localized Scleroderma: A Clinical & Immunohistochemical Comparative Study

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Evaluation of the efficacy of fractional carbon dioxide laser as a new method for treatment of localized scleroderma [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Assessing the degree of improvement of cases of localized scleroderma using each method [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Assessing the complications of each type of therapy [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    check list for each of common complications of Laser therapy & photo therapy is done for each patient.


Estimated Enrollment: 20
Study Start Date: April 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02002897

Contacts
Contact: Suzan M Shalaby, Ass.lecturer 01224019459 suzanshalaby@kasralainy.edu.eg
Contact: Manal AW Bosseila, Professor 01002412964 manal.bosseila@kasralainy.edu.eg

Locations
Egypt
Cairo University- Dermatology outpatient clinic Recruiting
Cairo, Egypt, 020
Contact: Suzan M Shalaby, Ass.lecturer    01224019459    suzanshalaby@kasralainy.edu.eg   
Contact: Manal AW Bosseila, Professor    01002412964    manal.bosseila@kasralainy.edu.eg   
Principal Investigator: Suzan M Shalaby, Ass.lecturer         
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Suzan M Shalaby, Ass.lecturer Cairo University
  More Information

Publications:
Responsible Party: Suzan Shalaby, Assisstant lecturer - Dermatology department - Faculty of medicine, Cairo University
ClinicalTrials.gov Identifier: NCT02002897     History of Changes
Other Study ID Numbers: DDCU-24684
Study First Received: September 5, 2013
Last Updated: December 2, 2013
Health Authority: Egypt: Institutional Review Board

Keywords provided by Cairo University:
Localized scleroderma UVA1 fractional carbon dioxide laser

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014