Contact information
Type
Scientific
Primary contact
Dr M W Linthorst Homan
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Dermatology
Netherlands Institute of Pigmentary Disorders
Meibergdreef 35
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 6955
m.w.linthorsthoman@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
NB-UVB vs Excimer
Study hypothesis
308-nm Excimer laser therapy will obtain faster repigmentation after mini-grafting than Narrow Band UltraViolet B (NB-UVB) therapy in vitiligo patients.
Ethics approval
Approval received from the Medical EThics Committee of the Academic Medical Centre in Amsterdam (Medisch Ethische Commissie) on the 23rd August 2006.
Study design
Randomised, controlled, crossover, single blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Vitiligo
Intervention
Mini-grafting in two symmetrical vitiligo patches on the trunk or extremties.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Percentage, start and grade of repigmentation.
Secondary outcome measures
Patient satisfaction.
Overall trial start date
01/09/2006
Overall trial end date
01/09/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
24
Participant 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
Recruitment start date
01/09/2006
Recruitment end date
01/09/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Center (AMC) (The Netherlands)
Sponsor details
Department of Dermatology
Netherlands Institute of Pigmentary Disorders
Meibergdreef 35
Amsterdam
1105 AZ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Center (AMC) (The Netherlands)
Alternative name(s)
Academic Medical Center, AMC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary