Trial · Interventional
CompletedPhase 2Registry dataAfamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo
Short name NSV
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 15 participants (actual)
- Sponsor
- Clinuvel Pharmaceuticals Limited · Industry
- Design
- Randomized · Open label (no masking)
- Countries
- Not stated
- Start
- Sept 2011
- Primary completion
- Jul 2012
- Completion
- Dec 2012
- First posted
- 27 Jun 2011 (estimated)
- Last update posted
- 22 Mar 2013 (estimated)
- Conditions
- Vitiligo
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to determine whether afamelanotide and narrow band UVB are effective in the treatment of non-segmental vitiligo (NSV).
Interventions
- AfamelanotideDrug
- NB-UVBDevice
Arms2
Experimental
Arm A: Afamelanotide + NB-UVB
Subject in this arm will receive both afamelanotide implants (one implant administered every 28 days, 6 implants in total) and NB-UVB light (administered thrice weekly, 72 treatments in total)
Active comparator
Arm B: NB-UVB alone
Subjects in this arm B will receive NB-UVB light only (administered thrice weekly, 72 treatments in total)
Primary outcomes1
Outcomes the sponsor listed as primary.
To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo
Time frame · 6 months
Registry description
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
Secondary outcomes(1)
Maintenance of pigmentation achieved
Time frame · 6 months
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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