Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2026-01-22 @ 12:57 PM
Study NCT ID:
NCT05396261
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2022-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
a Flexible Wound Dressing for the Management of Genital Skin Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D059268', 'term': 'Atrophic Vaginitis'}, {'id': 'D008010', 'term': 'Lichen Planus'}, {'id': 'D018459', 'term': 'Lichen Sclerosus et Atrophicus'}], 'ancestors': [{'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2022-05-19', 'studyFirstSubmitQcDate': '2022-05-24', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gynaecological skin condition', 'timeFrame': "Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months", 'description': 'Likert scales to measure:\n\n* Dryness\n* Tissue thinning\n* Erosion/Ulcers\n* Fissures\n* Erythema\n* Scarring/adhesion\n* Contact bleeding\n* Bloodblisters\n* Greyish film\n* White lacy streaks'}], 'secondaryOutcomes': [{'measure': 'patient symptoms', 'timeFrame': "Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months", 'description': 'Likert scales to measure:\n\n* Pruritus/itchiness\n* Tender/sore\n* Swelling\n* Dryness\n* Burning of skin\n* Dyspareunia\n* Stinging with urination/clothes\n* Defecating pain/burning'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginitis', 'Atrophic Vaginitis', 'Lichen Planus', 'Lichen Sclerosus', 'Menopause Related Conditions']}, 'referencesModule': {'references': [{'pmid': '39035147', 'type': 'DERIVED', 'citation': 'Hall P. A Feasibility Study Investigating a Topical Preparation as Novel Adjunct Treatment for the Symptomatic Management of Vulvovaginal Skin Conditions. Womens Health Rep (New Rochelle). 2024 May 17;5(1):444-452. doi: 10.1089/whr.2024.0026. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide informed consent\n* Diagnosed genital skin condition\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* Patient unable to apply topical device\n* Allergy or intolerance to ingredients or excipients of the formulation of studied products'}, 'identificationModule': {'nctId': 'NCT05396261', 'briefTitle': 'a Flexible Wound Dressing for the Management of Genital Skin Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stratpharma AG'}, 'officialTitle': 'Post-marketing Surveillance of a Flexible Wound Dressing for the Management of Genital Skin Conditions', 'orgStudyIdInfo': {'id': 'SPASMSX01 HALL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Film forming silicone gel (7-0940) is an innovative gel that forms a full contact, flexible wound dressing for supporting mucosal conditions of the genital, rectal and perineal areas.\n\nFilm forming silicone gel (7-0940) is a semi-occlusive, non-resorbable, self-drying and transparent gel.\n\nFilm forming silicone gel (7-0940) may be directly applied to dry, wet, cracked and sensitive mucosal tissue.\n\nFilm forming silicone gel (7-0940) gel is bacteriostatic and inert. It contains no alcohols, parabens or fragrances.', 'interventionNames': ['Device: Film forming silicone gel (7-0940)']}], 'interventions': [{'name': 'Film forming silicone gel (7-0940)', 'type': 'DEVICE', 'description': 'Anecdotal evidence suggests that genital conditions in women associated with vaginal atrophy improve with the use of film-forming silicone dressings.', 'armGroupLabels': ['Treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Spring Hill', 'state': 'Queensland', 'country': 'Australia', 'facility': 'St. Andrews War Memorial Hospital', 'geoPoint': {'lat': -27.46141, 'lon': 153.02311}}], 'overallOfficials': [{'name': 'Philip Hall, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Andrews War Memorial Hospital - Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stratpharma AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}