NCT05368857

Brief Summary

This mechanistic study's aim is to assess the DNA damage repair capabilities of afamelanotide in healthy volunteers with skin type I-III following exposure to ultraviolet radiation (UVR)-induced DNA damage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

April 21, 2022

Last Update Submit

February 8, 2023

Conditions

Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Change in UV photoproduct levels in UVR-exposed skin.

    Analysis of UV photoproducts from skin samples.

    From Baseline to Day 28

  • Change in rate of UV photoproduct repair in UVR-exposed skin.

    Analysis of UV photoproduct repair mechanisms from skin samples.

    From Baseline to Day 28.

Secondary Outcomes (3)

  • Change in UV-induced DNA damage and repair markers.

    From Baseline to Day 28

  • Change in Minimal Erythema Dose (MED).

    From Baseline to Day 28

  • Change in UVR-erythema dose-response.

    From Baseline to Day 28

Study Arms (1)

Afamelanotide

EXPERIMENTAL
Drug: Afamelanotide

Interventions

AfamelanotideDRUG

Up to 10 adult healthy volunteers will be enrolled in this study in which small areas of their skin will be exposed to UVR and skin samples taken. UV-induced DNA damage and repair will be analysed.

Afamelanotide

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female volunteers (aged 18-45) with Fitzpatrick skin types I, II or III.
  • Written informed consent obtained from volunteers prior to study-start.

You may not qualify if:

  • Female who is pregnant or lactating.
  • Females of child-bearing potential not using adequate contraceptive measures or a lifestyle excluding pregnancy.
  • Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures.
  • Any significant illness during the four weeks before the study screening period.
  • Taking known photosensitisers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CLINUVEL Investigational Site

Clinuvel Investigational Site, United Kingdom

Location

MeSH Terms

Interventions

afamelanotide

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

May 10, 2022

Study Start

January 19, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

February 9, 2023

Record last verified: 2023-02

Locations

GB(1)