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

Primary Purpose

Localized Scleroderma

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fractional carbon dioxide laser
Ultraviolet A1 phototherapy (UVA1)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Localized Scleroderma focused on measuring Localized scleroderma UVA1 fractional carbon dioxide laser

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo University- Dermatology outpatient clinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fractional carbon dioxide laser

Ultraviolet A1 phototherapy (UVA1)

Arm Description

Single session of fractional laser is done using DEKA machine , for 3 months .

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.

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

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 .

Full Information

First Posted
September 5, 2013
Last Updated
September 9, 2014
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02002897
Brief Title
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

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: -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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Scleroderma
Keywords
Localized scleroderma UVA1 fractional carbon dioxide laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fractional carbon dioxide laser
Arm Type
Experimental
Arm Description
Single session of fractional laser is done using DEKA machine , for 3 months .
Arm Title
Ultraviolet A1 phototherapy (UVA1)
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Fractional carbon dioxide laser
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Ultraviolet A1 phototherapy (UVA1)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of the efficacy of fractional carbon dioxide laser as a new method for treatment of localized scleroderma
Description
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 .
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Assessing the degree of improvement of cases of localized scleroderma using each method
Description
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 .
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Assessing the complications of each type of therapy
Description
check list for each of common complications of Laser therapy & photo therapy is done for each patient.
Time Frame
4 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Types of morphea: plaque, linear and atrophic. Patients are either new or discontinued systemic treatment for at least two months Exclusion Criteria: Morphea profunda and systemic scleroderma (diagnosed by: Rayaund's Phenomenon and sclerodactyly +/- internal organ affection) Contraindications to phototherapy: eg: photosensitivity, systemic lupus, melanoma, skin cancer, or porphyria. Contraindications to laser: Use of systemic retinoids in the last 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzan M Shalaby, Ass.lecturer
Phone
01224019459
Email
suzanshalaby@kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Manal AW Bosseila, Professor
Phone
01002412964
Email
manal.bosseila@kasralainy.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzan M Shalaby, Ass.lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University- Dermatology outpatient clinic
City
Cairo
ZIP/Postal Code
020
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzan M Shalaby, Ass.lecturer
Phone
01224019459
Email
suzanshalaby@kasralainy.edu.eg
First Name & Middle Initial & Last Name & Degree
Manal AW Bosseila, Professor
Phone
01002412964
Email
manal.bosseila@kasralainy.edu.eg
First Name & Middle Initial & Last Name & Degree
Suzan M Shalaby, Ass.lecturer

12. IPD Sharing Statement

Citations:
PubMed Identifier
22006130
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.
Results Reference
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Fractional Carbon Dioxide Laser Versus UVA 1 in Treatment of Localized Scleroderma

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