Excimer Lamp Versus Excimer Laser in Vitiligo Treatment

Vitiligo Clinical Trial

Official title:

Comparative Study of 308nm Excimer Lamp and 308nm Excimer Laser in the Treatment of Vitiligo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696358
• Other study ID #: NICE-VIT1
• Status: Completed
• Phase: Phase 3
• First received: June 10, 2008
• Last updated: October 30, 2008

Study information

• Verified date: October 2008
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Vitiligo

Intervention

Radiation:
• 308nm excimer lamp
50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks
• 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)

Locations

Country	Name	City	State
France	Department of Dermatology, University Hospital of Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repigmentation rate in the treated areas		12 weeks	No
Secondary	Tolerance and safety of the treatments		12 weeks	Yes