NB-UVB phototherapy versus Excimer laser after mini-grafting in vitiligo patients

ISRCTN	ISRCTN68425813
DOI	https://doi.org/10.1186/ISRCTN68425813
Secondary identifying numbers	NL778, NTR789

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

Academic Medical Center (AMC)
Department of Dermatology
Netherlands Institute of Pigmentary Disorders
Meibergdreef 35
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 6955
Email	m.w.linthorsthoman@amc.uva.nl

Study information

Study design	Randomised, controlled, crossover, single blinded trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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	Percentage, start and grade of repigmentation.
Secondary outcome measures	Patient satisfaction.
Overall study start date	01/09/2006
Completion date	01/09/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

Sponsor information

Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre

Department of Dermatology
Netherlands Institute of Pigmentary Disorders
Meibergdreef 35
Amsterdam
1105 AZ
Netherlands

Website	http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Academic Medical Center (AMC) (The Netherlands)
Private sector organisation / Universities (academic only)

Alternative name(s): Academic Medical Center, AMC
Location: Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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.