NB-UVB phototherapy versus Excimer laser after mini-grafting in vitiligo patients
| ISRCTN | ISRCTN68425813 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68425813 |
| Protocol serial number | NL778, NTR789 |
| Sponsor | Academic Medical Center (AMC) (The Netherlands) |
| Funder | Academic Medical Center (AMC) (The Netherlands) |
- Submission date
- 16/01/2007
- Registration date
- 16/01/2007
- Last edited
- 15/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M W Linthorst Homan
Scientific
Scientific
Academic Medical Center (AMC)
Department of Dermatology
Netherlands Institute of Pigmentary Disorders
Meibergdreef 35
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 6955 |
|---|---|
| m.w.linthorsthoman@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controlled, crossover, single blinded trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | NB-UVB phototherapy versus Excimer laser after mini-grafting in vitiligo patients |
| Study acronym | NB-UVB vs Excimer |
| Study objectives | 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(s) | Approval received from the Medical EThics Committee of the Academic Medical Centre in Amsterdam (Medisch Ethische Commissie) on the 23rd August 2006. |
| Health condition(s) or problem(s) studied | Vitiligo |
| Intervention | Mini-grafting in two symmetrical vitiligo patches on the trunk or extremties. |
| Intervention type | Other |
| Primary outcome measure(s) |
Percentage, start and grade of repigmentation. |
| Key secondary outcome measure(s) |
Patient satisfaction. |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 24 |
| Total final enrolment | 14 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2012 | 15/01/2021 | Yes | No |
Editorial Notes
15/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
