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Trial · Interventional

CompletedPhase 2Registry data

Afamelanotide 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
201120122013
  1. Ph 2

    NSV

    NCT01382589

    Sept 2011 to Dec 2012

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.

  1. 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)
  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
Inclusion criteria: * Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 15% to 50% of total body surface involvement * Stable or slowly progressive vitiligo over a 3-month period * Aged 18 or more * Fitzpatrick skin types III-VI * Willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator * Providing written Informed Consent prior to the performance of any study-specific procedure Exclusion criteria: * Fitzpatrick skin types I-II * Vitiligo involving the hands and feet only * Extensive leukotrichia, in the opinion of the Investigator * Vitiligo of more than 5 years duration * Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/lidocaine or other local anaesthetic to be used during the administration of the implant * Previous treatment with topical immunomodulators (corticosteroids, calcineurin inhibitors) for vitiligo within 4 weeks prior to the Screening Visit * History of photosensitivity disorders * Claustrophobia * History of photosensitive lupus * Any active and/or unstable autoimmune disease judged to be clinically significant by the Investigator * History of melanoma or lentigo maligna * History of dysplastic nevus syndrome * Any malignant skin lesions * Any skin disease that may interfere with the study evaluation * Any evidence of organ dysfunction or deviation from normal in clinical or laboratory determinations judged to be clinically significant by the Investigator * History of systemic or psychiatric disease judged to be clinically significant by the Investigator and which may interfere with the study evaluation * Female who is pregnant (confirmed by positive β-HCG pregnancy test) or lactating * Female of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device) during the trial and for a period of three months thereafter * Sexually active man with a partner of child-bearing potential not using barrier contraception during the trial and for a period of three months hereafter * Participation in a clinical trial for an investigational agent within 30 days prior to the Screening Visit * Use of any prior and concomitant therapy which may interfere with the objective of the study, including drugs that cause photosensitivity or skin pigmentation within 60 days prior to the Screening Visit * Subjects assessed as not suitable for the study in the opinion of the Investigator

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