A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-28

Study Completion Date

2024-12-31

Brief Summary

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The CUV152 study will evaluate the safety of afamelanotide in XP-C and XP-V patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the skin. It will assess whether SCENESSE® increases the amount of UV light needed to cause DNA damage of skin cells, as well as the extent of skin repair before and after treatment.

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Detailed Description

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Conditions

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Xeroderma Pigmentosum

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Afamelanotide

Group Type EXPERIMENTAL

Afamelanotide

Intervention Type DRUG

Patients will receive afamelanotide every two weeks for twelve weeks and undergo a follow up visit 6 months later.

Interventions

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Afamelanotide

Patients will receive afamelanotide every two weeks for twelve weeks and undergo a follow up visit 6 months later.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female patient with a molecular-genetically confirmed diagnosis of XP-C or XP-V;
* Aged 18-75 years.

Exclusion Criteria

* Known allergy to afamelanotide or the polymer contained in the implant;
* Presence of severe hepatic disease or hepatic impairment;
* Renal impairment;
* Any other medical condition which may interfere with the study protocol;
* Existing melanoma;
* Female who is pregnant or lactating;
* Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures;
* Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures;
* Use of any other prior and concomitant therapy which may interfere with the objective of the study;
* Participation in a clinical trial for an investigational agent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No