NCT05368857CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Clinuvel (UK) Ltd.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change in UV photoproduct levels in UVR-exposed skin.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- 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.
Arms & Interventions
Afamelanotide
Experimental
Intervention: Afamelanotide (Drug)
Outcomes
Primary Outcomes
Change in UV photoproduct levels in UVR-exposed skin.
Time Frame: From Baseline to Day 28
Analysis of UV photoproducts from skin samples.
Change in rate of UV photoproduct repair in UVR-exposed skin.
Time Frame: From Baseline to Day 28.
Analysis of UV photoproduct repair mechanisms from skin samples.
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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