Excimer Lamp Versus Excimer Laser in Vitiligo Treatment - Full Text View

Sponsored by:	Centre Hospitalier Universitaire de Nice
Information provided by:	Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:	NCT00696358

Purpose

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.

Condition	Intervention	Phase
Vitiligo	Radiation: 308nm excimer lamp Radiation: 308nm excimer laser	Phase III

MedlinePlus related topics: Vitiligo

U.S. FDA Resources

Study Type:	Interventional
Official Title:	Comparative Study of 308nm Excimer Lamp and 308nm Excimer Laser in the Treatment of Vitiligo

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:

Repigmentation rate in the treated areas [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tolerance and safety of the treatments [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Arms	Assigned Interventions
A: Active Comparator 308 nm excimer lamp	Radiation: 308nm excimer lamp 50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks
B: Active Comparator 308 nm excimer laser	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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696358

Locations

France
Department of Dermatology, University Hospital of Nice
Nice, France, 06200

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

More Information

Study ID Numbers:	NICE-VIT1
Study First Received:	June 10, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00696358
Health Authority:	France: Direction Générale de la Santé

Keywords provided by Centre Hospitalier Universitaire de Nice:

Vitiligo

Study placed in the following topic categories:

Hypopigmentation
Skin Diseases
Pigmentation Disorders
Hypomelanotic disorder
Vitiligo

ClinicalTrials.gov processed this record on January 15, 2009