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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
  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 3

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

Resource links provided by NLM:

MedlinePlus related topics: Vitiligo
U.S. FDA Resources

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
Active Comparator: A
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
Active Comparator: B
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

No publications provided

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

Keywords provided by Centre Hospitalier Universitaire de Nice:
Vitiligo

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013