Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy VolunteersPhase 1NCT05368857
DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers
A Phase 1 study testing Afamelanotide in people with Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers, run by Clinuvel (UK) Ltd. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers
- What is being tested?
- Afamelanotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jan 2022to 1 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
CLINUVEL Investigational Site
Clinuvel Investigational Site
About this study
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
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.
- Being tested
- Afamelanotide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Afamelanotide | Experimental | Not described Receives: Drug: Afamelanotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in UV photoproduct levels in UVR-exposed skin.
Analysis of UV photoproducts from skin samples.
Measured: 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.
Measured: From Baseline to Day 28.
Secondary outcomes (3)
Change in UV-induced DNA damage and repair markers.
Analysis of UV photoproducts and DNA repair mechanisms from skin samples.
Measured: From Baseline to Day 28
Change in Minimal Erythema Dose (MED).
Minimal erythema dose (MED) is the lowest dose of UV light that causes reddening of the skin.
Measured: From Baseline to Day 28
Change in UVR-erythema dose-response.
UVR erythema dose response measured with a non-invasive quantitative skin reflectance measurement.
Measured: From Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start19 Jan 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinuvel (UK) Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368857
- Sponsor's protocol ID
- CUV151
- Status last verified
- Feb 2023
- First submitted
- 21 Apr 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05368857
- Acronym / sponsor ID
- CUV151
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Clinuvel (UK) Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afamelanotide | Experimental | Drug: Afamelanotide |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfamelanotideUp 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. | Drug | Afamelanotide |
Primary outcome
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.
3 secondary outcomes
Change in UV-induced DNA damage and repair markers.
Time frame: From Baseline to Day 28
Change in Minimal Erythema Dose (MED).
Time frame: From Baseline to Day 28
Change in UVR-erythema dose-response.
Time frame: From Baseline to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Afamelanotide in people with Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers, run by Clinuvel (UK) Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in UV photoproduct levels in UVR-exposed skin. (time frame: From Baseline to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.