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Afamelanotide + NB-UVB for Nonsegmental Vitiligo
NCT01382589Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2011
- Primary completion
- Jul 2012
- Sponsor
- Clinuvel Pharmaceuticals
- Modality
- Peptides, Small Molecules
- Drugs
- Afamelanotide
- Conditions
- nonsegmental vitiligo (NSV)
01
Overview
Phase 2, randomised, open-label trial of Afamelanotide in nonsegmental vitiligo (NSV) (2 arms), sponsored by Clinuvel Pharmaceuticals. Primary endpoint: Efficacy of afamelanotide implants and NB-UVB light at 6 months. Started Sep 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Afamelanotide + NB-UVB
Afamelanotide implants + NB-UVB phototherapy
NB-UVB alone
NB-UVB phototherapy monotherapy
03
Who it enrols
Adult patients with stable or slowly progressive nonsegmental vitiligo (15-50% BSA) and Fitzpatrick skin types III-VI.
04
Endpoints
Primary
Efficacy of afamelanotide implants and NB-UVB light
Secondary
Maintenance of pigmentation achieved
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