B-UVB phototherapy versus Excimer laser after mini-grafting in vitiligo patients

Not Applicable

Completed

• Conditions: Vitiligo; Skin and Connective Tissue Diseases; Pigmentation disorder

• Registration Number: ISRCTN68425813
• Lead Sponsor: Academic Medical Center (AMC) (The Netherlands)

Brief Summary

2011 results in https://pubmed.ncbi.nlm.nih.gov/21711467/ (added 15/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-16
• Study Completion: 2007-09-01
• Last Update Posted: 25 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

1. Consecutive patients, diagnosed with stable vitiligo vulgaris (a few to many widespread depigmented macules over the entire body, with often a symmetrically distribution pattern) with symmetrical vitiligo patches. Definition of stable: no expansion of existing lesions or appearance of new lesions during the previous six months, absence of Koebner's phenomenon and a positive mini-grafting test
2. Patients, eligible for mini-grafting and NB-UVB/excimer therapy
3. Adult patients: older than 18 years

Exclusion Criteria

Patients:
1. With a history of hypertrophic scarring and/or keloid
2. With a history of allergic/phototoxic reaction (Lidocaine, Tegaderm, Suture strips, sunlight)
3. With a negative mini-grafting test
4. With a personal or a family history of skin cancer (non-melanoma skin cancer: first degree family members, melanoma: any family member)
5. With a personal history of photosensitivity and/or phototoxicity disorders
6. With skin type I (according to Fitzpatrick classification I-VI)
7. Who are pregnant
8. Who are taking medications known to cause photosensitivity and/or phototoxicity and chronic or very frequent use of any medication that can influence the UVB response (e.g. tetracycline, retinoids, sulfonamids, psoralens, Non-Steroidal Anti-Inflammatory Drugs [NSAIDs])
9. With other skin diseases that would impair evaluation of repigmentation, such as psoriasis and eczema
10. Who are not able to have two times weekly NB-UVB/Excimer therapy
11. With local immunosuppressive treatment six weeks prior to enrolment. For these patients a washout period of six weeks will be required

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage, start and grade of repigmentation.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction.