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

• Sponsor: Clinuvel (UK) Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05368857
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 8.4
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers	Drug: Afamelanotide	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Mechanistic Study to Evaluate Impact of Subcutaneous Implants of Afamelanotide on Ultraviolet Radiation-induced DNA Damage and DNA Repair Capacity in Healthy Volunteers With Skin Types I-III
• Actual Study Start Date: Jan 19, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Afamelanotide	Drug: Afamelanotide; 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.

Outcome Measures

Primary Outcome Measures

1. Change in UV photoproduct levels in UVR-exposed skin. [From Baseline to Day 28]

   Analysis of UV photoproducts from skin samples.

2. Change in rate of UV photoproduct repair in UVR-exposed skin. [From Baseline to Day 28.]

   Analysis of UV photoproduct repair mechanisms from skin samples.

Secondary Outcome Measures

1. Change in UV-induced DNA damage and repair markers. [From Baseline to Day 28]

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

2. Change in Minimal Erythema Dose (MED). [From Baseline to Day 28]

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

3. Change in UVR-erythema dose-response. [From Baseline to Day 28]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CLINUVEL Investigational Site	Clinuvel Investigational Site		United Kingdom

Sponsors and Collaborators

• Clinuvel (UK) Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clinuvel (UK) Ltd.
• ClinicalTrials.gov Identifier: NCT05368857
• Other Study ID Numbers: CUV151
• First Posted: May 10, 2022
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Afamelanotide

Study Results

No Results Posted as of Jun 21, 2022