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Trial · Interventional

Status unknownPhase 2Registry data

A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face

NCTNCT05210582 (opens ClinicalTrials.gov in a new tab)Other idCUV104
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 2
Enrollment
6 participants (estimated)
Sponsor
Clinuvel, Inc. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
11 Oct 2022
Primary completion
Apr 2023 (estimated)
Completion
Aug 2023 (estimated)
First posted
27 Jan 2022
Last update posted
9 Feb 2023
Conditions
Vitiligo

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024
  1. Ph 2

    A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face

    NCT05210582

    11 Oct 2022 to est. Aug 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The CUV104 study will assess the efficacy and safety of afamelanotide in patients with vitiligo on the face and body as a monotherapy in repigmentation.

Interventions

  • AfamelanotideDrug

Arms1

  • Experimental

    Afamelanotide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions

    Time frame · From Baseline to Day 84

    Registry description

    Measured using Vitiligo Area Scoring Index (VASI). A decrease in VASI indicates a reduction of the facial surface area affected by vitiligo (possible range 1-100)

Secondary outcomes(6)

  1. Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on body surface area

    Time frame · From Baseline to Day 84

    Registry description

    Proportion of participants achieving VASI25 on body surface area (excluding hands and feet). A decrease in VASI indicates a reduction of the facial surface area affected by vitiligo (possible range 1-100).

  2. Percentage change in pigmentation on body surface area measured by the VASI scoring system

    Time frame · From Baseline to Day 84

    Registry description

    Percentage change in pigmentation on body surface area (excluding hands and feet) measured by VASI scoring system. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100)

  3. Percentage change in pigmentation on facial surface area measured by the VASI scoring system

    Time frame · From Baseline to Day 168

    Registry description

    A decreased VASI indicates a reduction in the faces' degree of depigmentation (possible range 1-100)

  4. Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A)

    Time frame · From Baseline to Day 168

    Registry description

    The higher the score, the more severe the disease

  5. Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B)

    Time frame · From Baseline to Day 168

    Registry description

    Higher the value means lower noticeability

  6. Change in Quality of life using a vitiligo specific tool (C)

    Time frame · From Baseline to Day 168

    Registry description

    Higher value means a lower quality of life

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.

A trial that is still running, or that stopped early, may post results later.

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 patients with a confirmed diagnosis of vitiligo on the face and with T-VASI range 0.5-50% * Stable face vitiligo with F-VASI of at least 0.1% * Stable or slowly progressive vitiligo over a 3-month period * Fitzpatrick skin types IV-VI * Treatment with narrowband (NB)-UVB light 2-3 times per week during the last four weeks preceding the first implant for priming Exclusion Criteria: * Patients with segmental vitiligo * Fitzpatrick skin types I-III * Treatment with NB-UVB phototherapy in the last three months prior to phototherapy, excluding the sessions for priming in the four weeks prior to treatment. A 3-month washout period from phototherapy is necessary prior to priming. * Previous topical treatment for vitiligo * 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 * History of melanoma or lentigo maligna * Any current skin disease that may interfere with the study evaluation * Presence of severe hepatic disease or hepatic impairment * Renal impairment * 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 or lactating * Female of child-bearing potential not using adequate contraceptive measures during the treatment phase and for a period of three months thereafter * Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures, as described above * Participation in a clinical trial for an investigational agent within 30 days prior to the Screening Visit * Use of any other prior and concomitant therapy which may interfere with the objective of the study * Subjects assessed as not suitable for the study in the opinion of the Investigator

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