NCT00696358

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
Last Updated

October 31, 2008

Status Verified

October 1, 2008

First QC Date

June 10, 2008

Last Update Submit

October 30, 2008

Conditions

Keywords

Vitiligo

Outcome Measures

Primary Outcomes (1)

  • Repigmentation rate in the treated areas

    12 weeks

Secondary Outcomes (1)

  • Tolerance and safety of the treatments

    12 weeks

Study Arms (2)

A

ACTIVE COMPARATOR

308 nm excimer lamp

Radiation: 308nm excimer lamp

B

ACTIVE COMPARATOR

308 nm excimer laser

Radiation: 308nm excimer laser

Interventions

50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks

A

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)

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, University Hospital of Nice

Nice, 06200, France

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Lasers, Excimer

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
phase 3
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 10, 2008

First Posted

June 12, 2008

Last Updated

October 31, 2008

Record last verified: 2008-10

Locations