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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR789 |
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Date of registration:
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03/10/2006 |
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Primary sponsor: |
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Public title:
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NB-UVB phototherapy versus excimer laser after minigrafting in vitiligo patients.
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Scientific title:
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NB-UVB phototherapy versus excimer laser after minigrafting in vitiligo patients. - NB-UVB vs Excimer |
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Date of first enrolment:
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1/9/2006 |
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Target sample size:
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24 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=789 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Active; Group: Crossover; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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M.W.
Linthorst Homan |
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Address:
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Academic Medical Center (AMC), Department of Dermatology, Netherlands Institute of Pigmentary Disorders
Meibergdreef 35, Meibergdreef 35
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5666955 |
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Email:
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m.w.linthorsthoman@amc.uva.nl |
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Affiliation:
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Name:
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M.W.
Linthorst Homan |
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Address:
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Academic Medical Center (AMC), Department of Dermatology, Netherlands Institute of Pigmentary Disorders
Meibergdreef 35, Meibergdreef 35
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5666955 |
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Email:
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m.w.linthorsthoman@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Consecutive patients, diagnosed with stable vitiligo vulgaris* with symmetrical vitiligo patches.
*Vitiligo vulgaris: a few to many widespread depigmented macules over the entire body, with often a symmetrically distribution pattern.
Stable means: no expansion of existing lesions or appearance of new lesions during the previous 6 months, absence of Koebner's phenomenon and a positive minigrafting test;
2. Patients, eligible for minigrafting 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. History of allergic/phototoxic reaction (Lidocaine, Tegaderm, Suture strips, sunlight);
3. With a negative minigrafting 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 (eg. tetracycline, retinoids, sulfonamids, psoralens, NSAID¡¯s);
9. With other skin diseases that would impair evaluation of repigmentation, such as psoriasis and eczema;
10. Who are not able to have 2 times weekly NB-UVB/Excimer therapy;
11. With local immunosuppressive treatment or 6 weeks prior to enrolment. For these patients a washout period of 6 weekswill be required.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Vitiligo
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Intervention(s)
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Minigrafting in two symmetrical vitiligo patches on the trunk or extremties.
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Primary Outcome(s)
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Percentage, start and grade of repigmentation.
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Secondary Outcome(s)
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Patient satisfaction.
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Secondary ID(s)
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ISRCTN68425813
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N/A
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Source(s) of Monetary Support
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Academic Medical Center (AMC), Department of Dermatology, Netherlands Institute of Pigmentary Disorders
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