A Phase II Randomised Pilot Study to Compare the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV)

NCT01382589 Phase 2 COMPLETED

The purpose of this study is to determine whether afamelanotide and narrow band UVB are effective in the treatment of non-segmental vitiligo (NSV).

Details

Lead sponsor	Clinuvel Pharmaceuticals Limited
Phase	Phase 2
Status	COMPLETED
Enrolment	15
Start date	2011-09
Completion	2012-12

Conditions

• Vitiligo

Interventions

• Afamelanotide
• NB-UVB

Primary outcomes

• To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo — 6 months
  Time to onset of repigmentation of full body, face, trunk and extremities Pigmentation by VASI and VETF Maintenance of pigmentation Dermatology Life Quality Index (DLQI) Safety of the treatment will be assessed by: For selected study sites, immunomodulatory assessment Full body anterior and posterior photography Vitiligo lesion photography Examination of the skin and oral mucosa and digital photography Ophthalmologic examination