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Trial record 12 of 2526 for:    CARBON DIOXIDE

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

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ClinicalTrials.gov Identifier: NCT02002897
Recruitment Status : Unknown
Verified September 2014 by Suzan Shalaby, Cairo University.
Recruitment status was:  Recruiting
First Posted : December 6, 2013
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):
Suzan Shalaby, Cairo University

Tracking Information
First Submitted Date  ICMJE September 5, 2013
First Posted Date  ICMJE December 6, 2013
Last Update Posted Date September 11, 2014
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
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 .
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02002897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
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 .
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 2, 2013)
Assessing the complications of each type of therapy [ Time Frame: 4 months ]
check list for each of common complications of Laser therapy & photo therapy is done for each patient.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Fractional Carbon Dioxide Laser Versus UVA 1 in Treatment of Localized Scleroderma
Official Title  ICMJE Fractional Carbon Dioxide Laser Versus UVA1 Phototherapy for Treatment of Localized Scleroderma: A Clinical & Immunohistochemical Comparative Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Localized Scleroderma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Fractional carbon dioxide laser
    Single session of fractional laser is done using DEKA machine , for 3 months .
    Intervention: Device: Fractional carbon dioxide laser
  • 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.
    Intervention: Device: Ultraviolet A1 phototherapy (UVA1)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 2, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02002897
Other Study ID Numbers  ICMJE DDCU-24684
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Suzan Shalaby, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Suzan M Shalaby, Ass.lecturer Cairo University
PRS Account Cairo University
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP