Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-04-13 @ 10:51 PM
Study NCT ID:
NCT04905368
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2021-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Evaluation of SS-POR11
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2021-05-18', 'studyFirstSubmitQcDate': '2021-05-26', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11', 'timeFrame': 'Baseline', 'description': 'Frequency of AEs and SAEs'}, {'measure': 'Signs of intolerance associated with the topical use of SS-POR11', 'timeFrame': 'Week 2', 'description': 'Frequency of signs of intolerance, via evaluation of the Skin Tolerability Test'}, {'measure': 'Subject sensitivity to SS-POR11', 'timeFrame': 'Baseline', 'description': 'Frequency of signs of sensitivity, via evaluation of the Skin Tolerability Test.'}, {'measure': 'Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11', 'timeFrame': 'Week 2', 'description': 'Frequency of AEs and SAEs'}, {'measure': 'Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11', 'timeFrame': 'Week 4', 'description': 'Frequency of AEs and SAEs'}, {'measure': 'Signs of intolerance associated with the topical use of SS-POR11', 'timeFrame': 'Week 4', 'description': 'Frequency of signs of intolerance, via evaluation of the Skin Tolerability Test'}], 'secondaryOutcomes': [{'measure': 'Porphyrin distribution', 'timeFrame': 'Week 2, Week 4', 'description': 'Efficacy of SS-POR11 to reduce levels of porphyrins on the skin, as assessed by the VISIA® Skin Analysis System.\n\nAverage percent change in facial porphyrin distribution'}, {'measure': 'Investigator Global Assessment (IGA)', 'timeFrame': 'Week 2, Week 4', 'description': 'Frequency of subjects displaying at least a one-point improvement on the IGA, at follow up visits compared to baseline. The IGA is an ordinal scale with five grades corresponding to increasing severities of acne (e.g., 0 to 4).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne']}, 'descriptionModule': {'briefSummary': "The goal of the present study is to assess the safety of a topical probiotic (probiotic strain; SS-POR11) on acne prone-skin, and the impact of SS-POR11 on the distribution of porphyrins, in subjects with mild-to-moderate acne \\[Investigator's Global Assessment (IGA) 1-3\\]."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant\'s first language of French or English, given the written language of the ICF\n* Participants willing to sign the ICF upon entering the study\n* Participant must be willing and able (in the PI\'s opinion) to comply with all study requirements\n* Participant must be aged 18-40 years\n* Participant must have a screening and baseline IGA score of 1 (rare blemishes/clear skin) or 2-3 (mild to moderate facial acne vulgaris)\n* Participant must agree to appear on all evaluation days and conform to all study-related instructions\n* Participant must agree not to undergo any topical treatments in the areas under investigation during the study period\n\nExclusion Criteria:\n\n* Participants under the age of 18 years or over the age of 40\n* Refusal to sign the ICF\n* Participants has any injuries or tumors in the areas under investigation\n* Participant has a recent (i.e., 3 months) surgery or invasive treatment in the areas under investigation\n* Use of oral antibiotics within 4 weeks prior to start of study\n* Use of oral or topical "probiotic" products within one month prior to start of study\n* Prior (3 months) or planned use of chemical peels, microdermabrasion, microneedling, or exfoliants during the course of the study\n* Participant is using or has used within 3 months drugs such as corticosteroids, immunosuppressants, or others collagen-production inhibitors\n* Participant is pregnant or lactating or wishes to get pregnant within the next 3 months, or refuses to use appropriate contraceptive method (in case of women of childbearing potential)\n* Participant has active herpes simplex in the investigated areas or a history of herpes labialis with four or more outbreaks in the 12 months prior to baseline\n* Participant has immunocompromising diseases; any known allergy or hypersensitivity to any of the ingredients of the investigational product\n* Participants possessing any of the contraindications for use of SS-POR11\n* Participant has tattoos, piercings, excessive scarring (e.g., hypertrophic or keloid scars) in the areas under investigation\n* Current or prior (3 months) change in the use of retinoids; Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months; and any other criteria that at the discretion of the Investigator, could interfere with study assessments or expose the subject to undue risk by study participation.'}, 'identificationModule': {'nctId': 'NCT04905368', 'briefTitle': 'Safety Evaluation of SS-POR11', 'organization': {'class': 'NETWORK', 'fullName': 'Klynical Consulting & Services'}, 'officialTitle': 'Tolerability of a Topical Dermo-cosmetic Product in Acne-prone Subjects', 'orgStudyIdInfo': {'id': 'SS-POR11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SS-POR11', 'type': 'OTHER', 'description': 'Topical composition containing probiotic strains derived from human skin (SS-POR11). Participants will be instructed to apply it topically to face, twice weekly for the duration of the trial.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Westmount', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Klynical Consulting & Services', 'geoPoint': {'lat': 45.48341, 'lon': -73.59918}}], 'overallOfficials': [{'name': 'Kaitlyn Enright', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Klynical Consulting & Services'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klynical Consulting & Services', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}