Condition category
Skin and Connective Tissue Diseases
Date applied
16/01/2007
Date assigned
16/01/2007
Last edited
30/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes