- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00696358
Excimer Lamp Versus Excimer Laser in Vitiligo Treatment
Comparative Study of 308nm Excimer Lamp and 308nm Excimer Laser in the Treatment of Vitiligo
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Nice, France
- Department of Dermatology, University Hospital of Nice
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: A
308 nm excimer lamp
|
50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks
|
|
Active Comparator: B
308 nm excimer laser
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Repigmentation rate in the treated areas
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Tolerance and safety of the treatments
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NICE-VIT1
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