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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00368407
Other study ID # fmmu200504
Secondary ID
Status Completed
Phase N/A
First received August 23, 2006
Last updated August 23, 2006
Start date April 2005
Est. completion date July 2006

Study information

Verified date April 2005
Source Fourth Military Medical University
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial Summary

To determine the optimal treatment frequency of 308-nm excimer laser for vitiligo and identify the key clinical variable(s) associated with the treatment efficiency under the optimal treatment frequency.

Prospective, randomized, comparative study among groups of vitiligo patients treated with 308-nm excimer laser, with the limitation of no follow-up.


Description:

Vitiligo patients were treated with 308-nm excimer laser for 20 sessions at different frequencies (0.5×, 1.0×, 2.0× and 3.0× weekly). Treatment protocols adapted the dose to the lesions and not to the minimal erythemal dose. Treatment efficacy was blindly evaluated by 2 independent physicians. Re-pigmentation rate was graded on a 6-point scale. The onset of re-pigmentation of vitiligo lesions was evaluated after 5 treatment sessions. The differences between Group 0.5×, 1.0×, 2.0× and 3.0× linking different clinical variables were assessed.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date July 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 60 Years
Eligibility Inclusion Criteria:

- older than 2 years, stable vitiliginous patches during the past 3 months with surfaces of at least 4cm2, and an understanding of all information given by signing a written consent form.

Exclusion Criteria:

- pregnant or breastfeeding women; personal history of a hypertrophic scar, skin cancer; taking immunosuppressive or photosensitizing drugs and undergoing phototherapy during the past 3 months.

Study Design

Allocation: Random Sample, Primary Purpose: Screening, Time Perspective: Longitudinal


Related Conditions & MeSH terms


Intervention

Device:
308-nm excimer laser


Locations

Country Name City State
China Department of dermatology, Xijing Hospital Xi'an SHANNXI

Sponsors (1)

Lead Sponsor Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Hofer A, Hassan AS, Legat FJ, Kerl H, Wolf P. Optimal weekly frequency of 308-nm excimer laser treatment in vitiligo patients. Br J Dermatol. 2005 May;152(5):981-5. — View Citation

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