Trials Sponsors Conditions Drugs Pricing

Conditions

Xeroderma Pigmentosum

Outcome Measures

Primary Outcomes (1)

Change in minimal erythema dose (MED).
MED is the lowest dose of UV light that causes reddening of the skin.
From Baseline to Day 76.

Secondary Outcomes (7)

Change in UV-induced DNA damage and repair capacity.
From Baseline to Day 76.
Change in skin disease severity (A).
From Baseline to Day 238.
Change in skin disease severity (B).
From Baseline to Day 238.
Change in skin disease severity (C).
From Baseline to Day 238.
Change in dermal melanin density.
From Baseline to Day 238.
+2 more secondary outcomes

Study Arms (1)

Afamelanotide

EXPERIMENTAL

Drug: Afamelanotide

Interventions

AfamelanotideDrug

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

Afamelanotide

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Clinuvel Europe Limited
Industrylead

Study Sites (1)

CLINUVEL investigative site

Regensburg, Germany

RECRUITING

Head of Clinical OperationsCONTACTmail@clinuvel.com

MeSH Terms

Conditions

Xeroderma Pigmentosum

Interventions

afamelanotide

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornPhotosensitivity DisordersSkin DiseasesSkin and Connective Tissue DiseasesPigmentation DisordersDNA Repair-Deficiency Disorders

Central Study Contacts

Head of Clinical Operations

CONTACT

+441372860765 mail@clinuvel.com

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 9, 2021

First Posted

December 16, 2021

Study Start

October 19, 2021

Actual (reported)

Primary Completion

March 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Afamelanotide

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Afamelanotide

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations