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Trial · Interventional

CompletedPhase 1Registry data

Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV)

Short name CUV102

Overview

Status
Completed
Phase
Phase 1
Enrollment
56 participants (actual)
Sponsor
Clinuvel Pharmaceuticals Limited · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jun 2011
Primary completion
May 2012
Completion
Nov 2012
First posted
8 Sept 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 1

    CUV102

    NCT01430195

    Jun 2011 to Nov 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 look at the efficacy of afamelanotide, when combined with narrow-band ultraviolet B (NB-UVB) light, in patients with nonsegmental vitiligo. Afamelanotide is expected to speed up the repigmentation induced by NB-UVB light, leading to reducing frequency and doses of NB-UVB.

Interventions

  • AfamelanotideDrug
  • Narrow-Band UVB Light TreatmentProcedure

Arms2

  • Experimental

    Afamelanotide + NB-UVB: Experimental

    Subject in this arm will receive both afamelanotide implants (one implant administered every 28 days, 4 implants in total) and NB-UVB light (administered thrice weekly, 72 treatments in total).

  • Active comparator

    NB-UVB alone: Active Comparator

    Subjects in this arm will receive NB-UVB light only (administered thrice weekly, 72 treatments in total).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Pigmentation of full body, face, trunk and extremities using the VASI and VETF scores

    Time frame · 6 months

Secondary outcomes(5)
  1. Time to onset of repigmentation of full body, face, trunk and extremities

    Time frame · 6 months

  2. Quality of life using the Dermatology Life Quality Index (DLQI)

    Time frame · 6 months

  3. Vitiligo biopsies assessments (optional, selected sites only)

    Time frame · 6 months

  4. Short term safety of both treatments: Routine laboratory assessments - Full body anterior and posterior photography - Vitiligo lesion photography - Examination of the skin and oral mucosa and digital photography - Ophthalmologic examination

    Time frame · 6 months

  5. Maintenance of pigmentation using the VASI and VETF scores

    Time frame · 12 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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

10 results

Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial.

Lim et al. 2015JAMA dermatologycited by 114

PMID 25230094DOI 10.1001/jamadermatol.2014.1875PUB-25230094

Full text at the publisher10 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male and female subjects with a confirmed diagnosis 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 * Previous treatment with NB-UVB within 6 months prior to the Screening Visit * Patient not responsive to previous NB-UVB treatment, defined as a patient who has undergone at least 30 NB-UVB sessions with no or minimal clinically relevant pigmentary response, in the opinion of the Investigator * Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/lidocaine or other local anesthetic 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), are 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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