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Trial · Interventional

CompletedPhase 1Registry data

DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers

NCTNCT05368857 (opens ClinicalTrials.gov in a new tab)Other idCUV151
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Overview

Status
Completed
Phase
Phase 1
Enrollment
10 participants (actual)
Sponsor
Clinuvel (UK) Ltd. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United Kingdom

Start
19 Jan 2022
Primary completion
1 Feb 2023
Completion
1 Feb 2023
First posted
10 May 2022
Last update posted
9 Feb 2023
Conditions
Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers

Timeline

1 trial · 1 completed

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

    DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers

    NCT05368857

    19 Jan 2022 to 1 Feb 2023

Registry summary

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

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.

Interventions

  • AfamelanotideDrug

Arms1

  • Experimental

    Afamelanotide

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · From Baseline to Day 28

    Registry description

    Analysis of UV photoproducts from skin samples.

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

    Time frame · From Baseline to Day 28.

    Registry description

    Analysis of UV photoproduct repair mechanisms from skin samples.

Secondary outcomes(3)

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

    Time frame · From Baseline to Day 28

    Registry description

    Analysis of UV photoproducts and DNA repair mechanisms from skin samples.

  2. Change in Minimal Erythema Dose (MED).

    Time frame · From Baseline to Day 28

    Registry description

    Minimal erythema dose (MED) is the lowest dose of UV light that causes reddening of the skin.

  3. Change in UVR-erythema dose-response.

    Time frame · From Baseline to Day 28

    Registry description

    UVR erythema dose response measured with a non-invasive quantitative skin reflectance measurement.

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.

Completed trials do not always post results.

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 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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