Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-27 @ 12:10 PM
Study NCT ID:
NCT04943159
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Afamelanotide in Patients Suffering With Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C534526', 'term': 'afamelanotide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mail@clinuvel.com', 'title': 'Clinical Operations Manager', 'organization': 'CLINUVEL PHARMACEUTICALS LTD'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'A pooled analysis of all the patients treated by afamelanotide (group A and group B) was conducted as only 3 patients were recruited in the study (2 in group A and one in group B) due to difficulties in recruitment.', 'eventGroups': [{'id': 'EG000', 'title': 'Afamelanotide (Pooled Analysis)', 'description': '* Group A are administered afamelanotide implant on Days 0, 21 and 42;\n* Group B are administered afamelanotide implant on Days 0 and 28.', 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Change in Number of Facial Inflammatory Acne-related Lesions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Afamelanotide (Pooled Analysis)', 'description': '* Group A are administered afamelanotide implant on Days 0, 21 and 42;\n* Group B are administered afamelanotide implant on Days 0 and 28.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '46', 'spread': '30.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '23.7', 'spread': '15.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 56.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A pooled analysis of all the patients treated by afamelanotide (group A and group B) was conducted as only 3 patients were recruited in the study (2 in group A and one in group B) due to difficulties in recruitment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Afamelanotide (Pooled Analysis)', 'description': '* Group A are administered afamelanotide implant on Days 0, 21 and 42;\n* Group B are administered afamelanotide implant on Days 0 and 28.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A pooled analysis of all the patients treated by afamelanotide (group A and group B) was conducted as only 3 patients were recruited in the study (2 in group A and one in group B) due to difficulties in recruitment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Afamelanotide (Pooled Analysis)', 'description': '* Group A are administered afamelanotide implant on Days 0, 21 and 42;\n* Group B are administered afamelanotide implant on Days 0 and 28.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A pooled analysis of all the patients treated by afamelanotide (group A and group B) was conducted as only 3 patients were recruited in the study (2 in group A and one in group B) due to difficulties in recruitment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2011-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2021-06-21', 'resultsFirstSubmitDate': '2021-08-13', 'studyFirstSubmitQcDate': '2021-06-21', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-28', 'studyFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change in Number of Facial Inflammatory Acne-related Lesions.', 'timeFrame': 'From baseline to Day 56.'}]}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of afamelanotide on the facial inflammatory acne-related lesions in patients with mild to moderate acne vulgaris, including tolerability of afamelanotide by patients with moderate acne vulgaris and effects of the treatment on quality of life in eligible patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male subjects with a diagnosis of mild to moderate acne vulgaris, defined as an Investigator's global assessment (IGA) score of 2-3;\n* Chronic course of acne vulgaris;\n* Acne-related lesions both on the face, chest and back;\n* Indication for treatment of acne vulgaris;\n* Aged 18-30 years (inclusive);\n* Fitzpatrick skin types I-III;\n* Providing written Informed Consent prior to the performance of any study-specific procedure.\n\nExclusion Criteria:\n\n* Female subjects;\n* Diagnosis of severe acne vulgaris;\n* Allergy to afamelanotide or the polymer contained in the implant or to lidocaine or other local anesthetic to be used during the administration of the implant;\n* Use of topical acne medication such as retinoids, benzoyl peroxide or topical antibiotics within 2 weeks prior to the first dose;\n* Use of oral antibiotics for acne within 4 weeks prior to the first dose;\n* Use of topical corticosteroids on the face, chest and back or systemic corticosteroids within the past 4 weeks prior to the first dose;\n* Use of systemic retinoids within 6 months prior to the first dose;\n* Use of anti-androgenic agents such as finasteride within 4 weeks prior to the first dose;\n* Use of phototherapy devices for acne such as ClearLight™ or Zenozapper within 1 week prior to the first dose;\n* Use of tanning booths or lamps within 1 week prior to the first dose;\n* Active skin disease that may interfere with evaluation;\n* Other forms of acne such as acne rosacea, acne excoriée, chloracne, acne conglobata, acne fulminans, acne inversa or drug-induced acne;\n* Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit."}, 'identificationModule': {'nctId': 'NCT04943159', 'briefTitle': 'Afamelanotide in Patients Suffering With Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clinuvel Pharmaceuticals Limited'}, 'officialTitle': 'A Phase II, Randomised, Open Label Pilot Study to Evaluate the Efficacy and Safety of Two Dosage Regimens of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Mild to Moderate Acne Vulgaris', 'orgStudyIdInfo': {'id': 'CUV100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Afamelanotide group A', 'interventionNames': ['Drug: Afamelanotide']}, {'type': 'EXPERIMENTAL', 'label': 'Afamelanotide group B', 'interventionNames': ['Drug: Afamelanotide']}], 'interventions': [{'name': 'Afamelanotide', 'type': 'DRUG', 'description': 'Group A is administered afamelanotide implant on Days 0, 21 and 42; Group B is administered afamelanotide implant on Days 0 and 28.', 'armGroupLabels': ['Afamelanotide group A', 'Afamelanotide group B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinuvel Pharmaceuticals Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}