| - candidate number | 2279 |
| - NTR Number | NTR789 |
| - ISRCTN | ISRCTN68425813 |
| - Date ISRCTN created | 16-jan-2007 |
| - date ISRCTN requested | 29-dec-2006 |
| - Date Registered NTR | 3-okt-2006 |
| - Secondary IDs | N/A |
| - Public Title | NB-UVB phototherapy versus excimer laser after minigrafting in vitiligo patients. |
| - Scientific Title | NB-UVB phototherapy versus excimer laser after minigrafting in vitiligo patients. |
| - ACRONYM | NB-UVB vs Excimer |
| - hypothesis | 308-nm Excimer lasertherapy will obtain faster repigmentation after minigrafting than NB-UVB therapy in vitiligo patients. |
| - Healt Condition(s) or Problem(s) studied | Vitiligo |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Active |
| - group | Crossover |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-sep-2006 |
| - planned closingdate | 1-sep-2007 |
| - Target number of participants | 24 |
| - Interventions | Minigrafting in two symmetrical vitiligo patches on the trunk or extremties. |
| - Primary outcome | Percentage, start and grade of repigmentation. |
| - Secondary outcome | Patient satisfaction. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | M.W. Linthorst Homan |
| - CONTACT for SCIENTIFIC QUERIES | M.W. Linthorst Homan |
| - Sponsor/Initiator | Academic Medical Center (AMC), Department of Dermatology, Netherlands Institute of Pigmentary Disorders |
| - Funding (Source(s) of Monetary or Material Support) | Academic Medical Center (AMC), Department of Dermatology, Netherlands Institute of Pigmentary Disorders |
| - Publications | N/A |
| - Brief summary | Vitiligo is a common, idiopathic acquired pigment disorder. Several treatment options are available; non-surgical therapies and surgical therapies. Surgical therapies can be considered for stable vitiligo patches. In the Netherlands Institute for Pigment Disorders (NIPD) we routinely use the autologous minigrafting technique. This technique is relatively simple among the surgical modalities and has been an effective therapy for stable localised and generalised vitiligo. Exposure to Narrow-Band Ultraviolet B (NB-UVB)following the minigrafting stimulates the spreading of melanocytes from the treated vitiligo lesion and obtains a faster rate of repigmentation. Recently the 308-nm Excimerlaser is introduced as an effective method of treatment for vitiligo and appears to be more effective than NBUVB as it produces more rapid and profound repigmentation. To our knowledge, no studies have been published on minigrafting followed by NB-UVB versus Excimer laser. The aim of this study is to evaluate the clinical effects (start and grade of repigmentation) of NB-UVB versus 308-nm Excimer lasertherapy on pigment spread after minigrafting in vitiligo patients. |
| - Main changes (audit trail) | |
| - RECORD | 3-okt-2006 - 9-dec-2009 |
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