Excimer Lamp Versus Excimer Laser in Vitiligo Treatment

This study has been completed.

Sponsor:

Information provided by:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT00696358

First received: June 10, 2008

Last updated: October 30, 2008

Last verified: October 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	June 10, 2008
Last Updated Date	October 30, 2008
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 11, 2008)	Repigmentation rate in the treated areas [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00696358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 11, 2008)	Tolerance and safety of the treatments [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Excimer Lamp Versus Excimer Laser in Vitiligo Treatment
Official Title ^ICMJE	Comparative Study of 308nm Excimer Lamp and 308nm Excimer Laser in the Treatment of Vitiligo
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Vitiligo
Intervention ^ICMJE	Radiation: 308nm excimer lamp 50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks Radiation: 308nm 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)
Study Arm (s)	Active Comparator: A 308 nm excimer lamp Intervention: Radiation: 308nm excimer lamp Active Comparator: B 308 nm excimer laser Intervention: Radiation: 308nm excimer laser
Publications *	Not Provided
* 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	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT00696358
Other Study ID Numbers ^ICMJE	NICE-VIT1
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Centre Hospitalier Universitaire de Nice
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Centre Hospitalier Universitaire de Nice
Verification Date	October 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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