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Excimer Lamp Versus Excimer Laser in Vitiligo Treatment

Primary Purpose

Vitiligo

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
308nm excimer lamp
308nm excimer laser
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Vitiligo focused on measuring Vitiligo

Eligibility Criteria

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

Inclusion Criteria:

  • patient above 18
  • vitiligo for more than 3 months
  • at least 2 vitiligo symmetric patches more than 10cm²
  • to read and understand the inform consent
  • to have a social security number
  • non pregnant for women

Exclusion Criteria:

  • pregnant women
  • keloids
  • history of radiotherapy or skin cancer in the treated areas
  • treatment for vitiligo in the past 4 weeks
  • phototherapy in the past 12 weeks; history of photodermatosis
  • treatment inducing photosensibilization
  • immunosuppression
  • patient who participated in a study in the past 3 months

Sites / Locations

  • Department of Dermatology, University Hospital of Nice

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

308 nm excimer lamp

308 nm excimer laser

Outcomes

Primary Outcome Measures

Repigmentation rate in the treated areas

Secondary Outcome Measures

Tolerance and safety of the treatments

Full Information

First Posted
June 10, 2008
Last Updated
October 30, 2008
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT00696358
Brief Title
Excimer Lamp Versus Excimer Laser in Vitiligo Treatment
Official Title
Comparative Study of 308nm Excimer Lamp and 308nm Excimer Laser in the Treatment of Vitiligo
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

5. Study Description

Brief Summary
308 nm excimer lamp and 308 nm excimer laser have both provide interesting results in treating vitiligo. They have the same wavelength but the type of emission of the photons is different. To date there is no direct comparative data concerning these two devices in this indication. The aim of the study is to make an intra-individual prospective comparison between these two phototherapies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
Vitiligo

7. Study Design

Study Phase
Phase 3

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
308 nm excimer lamp
Arm Title
B
Arm Type
Active Comparator
Arm Description
308 nm excimer laser
Intervention Type
Radiation
Intervention Name(s)
308nm excimer lamp
Intervention Description
50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks
Intervention Type
Radiation
Intervention Name(s)
308nm excimer laser
Intervention Description
50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks (same doses will be used between the 2 arms)
Primary Outcome Measure Information:
Title
Repigmentation rate in the treated areas
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Tolerance and safety of the treatments
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient above 18 vitiligo for more than 3 months at least 2 vitiligo symmetric patches more than 10cm² to read and understand the inform consent to have a social security number non pregnant for women Exclusion Criteria: pregnant women keloids history of radiotherapy or skin cancer in the treated areas treatment for vitiligo in the past 4 weeks phototherapy in the past 12 weeks; history of photodermatosis treatment inducing photosensibilization immunosuppression patient who participated in a study in the past 3 months
Facility Information:
Facility Name
Department of Dermatology, University Hospital of Nice
City
Nice
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

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Excimer Lamp Versus Excimer Laser in Vitiligo Treatment

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