RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open Label, Phase II Study to Assess the Changes in Pigmentation and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants in the Treatment of Vitiligo on the Face

Quick Facts

Study Start:2022-10-11

Study Completion:2023-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05210582

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Head of Clinical Operations

CONTACT

+441372860765

mail@clinuvel.com

Study Locations (Sites)

CLINUVEL Investigational site

Detroit, Michigan, 48202

United States

Collaborators and Investigators

Sponsor: Clinuvel, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-11

Study Completion Date2023-08

Study Record Updates

Study Start Date2022-10-11

Study Completion Date2023-08

Terms related to this study

Additional Relevant MeSH Terms

Vitiligo