NCT02002897

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

1.6 years

First QC Date

September 5, 2013

Last Update Submit

September 9, 2014

Conditions

Localized Scleroderma

Keywords

Localized scleroderma UVA1 fractional carbon dioxide laser

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Assessing the degree of improvement of cases of localized scleroderma using each method

    4 months

Other Outcomes (1)

  • Assessing the complications of each type of therapy

    4 months

Study Arms (2)

Fractional carbon dioxide laser

EXPERIMENTAL

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

Device: Fractional carbon dioxide laser

Ultraviolet A1 phototherapy (UVA1)

ACTIVE COMPARATOR

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)

Interventions

Fractional carbon dioxide laserDEVICE

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.

Fractional carbon dioxide laser
Ultraviolet A1 phototherapy (UVA1)DEVICE

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.

Ultraviolet A1 phototherapy (UVA1)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Types of morphea: plaque, linear and atrophic.
  • Patients are either new or discontinued systemic treatment for at least two months

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University- Dermatology outpatient clinic

Cairo, 020, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22006130BACKGROUND

MeSH Terms

Conditions

Scleroderma, Localized

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Suzan M Shalaby, Ass.lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzan M Shalaby, Ass.lecturer

CONTACT

01224019459suzanshalaby@kasralainy.edu.eg

Manal AW Bosseila, Professor

CONTACT

01002412964manal.bosseila@kasralainy.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant lecturer - Dermatology department - Faculty of medicine

Study Record Dates

First Submitted

September 5, 2013

First Posted

December 6, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations

EG(1)