Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-31 @ 1:20 AM
Study NCT ID:
NCT05368857
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2022-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C534526', 'term': 'afamelanotide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-08', 'studyFirstSubmitDate': '2022-04-21', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in UV photoproduct levels in UVR-exposed skin.', 'timeFrame': 'From Baseline to Day 28', 'description': 'Analysis of UV photoproducts from skin samples.'}, {'measure': 'Change in rate of UV photoproduct repair in UVR-exposed skin.', 'timeFrame': 'From Baseline to Day 28.', 'description': 'Analysis of UV photoproduct repair mechanisms from skin samples.'}], 'secondaryOutcomes': [{'measure': 'Change in UV-induced DNA damage and repair markers.', 'timeFrame': 'From Baseline to Day 28', 'description': 'Analysis of UV photoproducts and DNA repair mechanisms from skin samples.'}, {'measure': 'Change in Minimal Erythema Dose (MED).', 'timeFrame': 'From Baseline to Day 28', 'description': 'Minimal erythema dose (MED) is the lowest dose of UV light that causes reddening of the skin.'}, {'measure': 'Change in UVR-erythema dose-response.', 'timeFrame': 'From Baseline to Day 28', 'description': 'UVR erythema dose response measured with a non-invasive quantitative skin reflectance measurement.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female volunteers (aged 18-45) with Fitzpatrick skin types I, II or III.\n* Written informed consent obtained from volunteers prior to study-start.\n\nExclusion Criteria:\n\n* Female who is pregnant or lactating.\n* Females of child-bearing potential not using adequate contraceptive measures or a lifestyle excluding pregnancy.\n* Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures.\n* Any significant illness during the four weeks before the study screening period.\n* Taking known photosensitisers.'}, 'identificationModule': {'nctId': 'NCT05368857', 'briefTitle': 'DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clinuvel Pharmaceuticals Limited'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CUV151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Afamelanotide', 'interventionNames': ['Drug: Afamelanotide']}], 'interventions': [{'name': 'Afamelanotide', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Afamelanotide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clinuvel Investigational Site', 'country': 'United Kingdom', 'facility': 'CLINUVEL Investigational Site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinuvel (UK) Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}