Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT04659668
Status:
COMPLETED
Last Update Posted:
2020-12-09
First Post:
2020-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Safety of the Dermal Filler for Female Intimate Area Hydration and Atrophy of the Vagina.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004414', 'term': 'Dyspareunia'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'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': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-02', 'studyFirstSubmitDate': '2020-11-20', 'studyFirstSubmitQcDate': '2020-12-02', 'lastUpdatePostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal Maturation Index (VMI) absolute change', 'timeFrame': 'From baseline to Day 60 (up to 8 weeks).', 'description': 'Improvement in the properties of the vaginal wall, measured by the VMI.'}, {'measure': 'Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'From screening through study completion, an average of 60 days - daily.', 'description': 'Frequency and severity of adverse events (AEs) and adverse device effect'}], 'secondaryOutcomes': [{'measure': 'The change in the Gloria Bachmann Vaginal Health Index (VHI)', 'timeFrame': 'From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks).', 'description': 'The VHI is a score formed by 5 parameters (vaginal elasticity, vaginal secretions, pH, epithelial mucous membrane, vaginal hydration). The final score defines the degree of atrophy in the genitourinary tract by assigning a single score to each parameter. The maximum possible score is 25, while the minimum possible score is 5.'}, {'measure': 'The absolute change in Visual Analogous Scale (VAS).', 'timeFrame': 'From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks).', 'description': 'The absolute change in VAS, ranged between 0 (no pain) and 10 (worst possible pain), judged by the Principal Investigator.'}, {'measure': 'The absolute change in Visual Analogous Scale (VAS)', 'timeFrame': 'From Day 0 to Day 30 (4 weeks) and Day 60 (up to 8 weeks).', 'description': 'The absolute change in VAS ranged between 0 (no pain) and 10 (worst possible pain), judged by the subject.'}, {'measure': 'The change of the Female Sexual Function Index (FSFI) score.', 'timeFrame': 'From Day 0 to Day 30 and Day 60 (up to 4 weeks and 8 weeks respectively).', 'description': 'The FSFI is a validated questionnaire to measure the sexual functioning of women. The score ranges between 2 (minimum) and 36 (maximum).'}, {'measure': 'Subject satisfaction evaluated by the Global Impression of Improvement (PGI-I) questionnaire', 'timeFrame': 'From Day 30 (4 weeks) to Day 60 (up to 8 weeks).', 'description': 'The PGI-I is a transition single question scale, asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better) to 7 (Very much worse)'}, {'measure': 'The change if the Nugent Score', 'timeFrame': 'From baseline to Day 60 (up to 8 weeks).', 'description': 'The Nugent Score is a Gram stain scoring system for vaginal swabs to diagnose bacterial vaginosis, relying on scoring of individual types of organisms; a score of 0 to 10 is derived from a weighted combination of the following: large Gram-positive rods (lactobacilli; decrease in Lactobacillus scored as 0 to 4), small Gram-negative or Gram-variable rods (G. vaginalis or other anaerobes; scored as 0 to 4), and curved Gram-negative or Gram-variable rods (Mobiluncus spp.; scored as 0 to 2).'}, {'measure': 'Viganal biopsy (optional)', 'timeFrame': 'From Day 0 up to Day 60 (up to 8 weeks).', 'description': 'Evaluation of the mitotic activity of the mucosa (Ki-67 proliferation marker - %).'}, {'measure': "Participant's Questionnaire", 'timeFrame': 'From Day 0 to Day 30 and Day 60 (up to week 4 and 8 respectively).', 'description': 'To register the overall discomfort and satisfaction of the subjects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Atrophy', 'Vulvovaginal Signs and Symptoms', 'Dyspareunia', 'Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler "MMG-23-04-2019" on the female genital area for the medicinal, functional and reconstructive indications.', 'detailedDescription': 'The Dermal Filler is recommended for the female intimate areas, especially the internal area of the vagina (vaginal vestibule, introitus, vaginal walls, clitoris, "G" spot) for the following indications: vaginal dryness or discomfort, vaginal atrophy.\n\nThe main functional ingredient is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation.\n\nThe MMG-23-04-2019 is contained in pre-filled, graduated and disposable sterile syringe with Luer Lock adapter with 1 ml of net content and 20 mg/ml hyaluronic acid.\n\nThe MMG-23-04-2019 has been classified as a Class III medical device under Annex IX of Directive MDD 93/42 EEC since it is a long-term, invasive and absorbable medical device.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Gender-based pathology.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female subject aged ≥18;\n* Subject presenting vaginal atrophy, dryness, dyspareunia or discomfort in the intimate area;\n* Subject who presents no other type of pathology of the area to be treated;\n* Subject who is willing to abstain from any cosmetic or surgical procedures in the treatment area during the clinical investigation;\n* Subject who is willing to participate in all study related activities and who is available for the duration of their participation in the investigation for follow-up;\n* Absence of a history of significant hypersensitivity to food and drugs or known sensitivity to hyaluronic acid;\n* Clinically and anamnestic healthy individual;\n* Arterial blood pressure (BP) (after 5 min. at rest in the supine position) systolic 90 - 140 mmHg and diastolic 50 - 90 mmHg;\n* Heart rate (HR) (after 5 min. at rest in the supine position) over 50 beats/min and less than 90 beats/min;\n* Respiratory rate between 12 - 24 breaths/min;\n* An axillar body temperature of up to 37 degrees celsius;\n* Clinical-laboratory examinations within the reference ranges or with no clinically significant abnormalities;\n* Negative AIDS/HIV test;\n* Negative pregnancy test for the women with reproductive potential;\n* A reliable and acceptable method of contraception for the women of child-bearing potential:\n* Signed written Informed Consent Form\n\nExclusion Criteria:\n\n* Subject with known sensitivity to hyaluronic acid or significant hypersensitivity to food and drugs;\n* Subject with a history of vulvar cancer and/or previous regional radiotherapy;\n* Subject with genital prolapse with a surgical indication or stress incontinence with a surgical indication;\n* A subject who suffers from vaginism;\n* Subject with genital bleeding of unknown origin;\n* Subject with frequent or present active herpes simplex or herpes zoster local infection or active herpes simplex or herpes zoster infection in other sites;\n* Subject with a history of frequent or active local dermatitis (of the injection site), vulvar scaly papilloma, mycosis; bacterial infection or laboratory tests indicating for such;\n* A subject suffering from autoimmune diseases or who are undergoing treatment with immunosuppressors or immunotherapy;\n* Subject with uncontrolled systemic diseases or who are undergoing current treatment with antihypertensives, steroid anti-inflammatory drugs anticoagulants, aspirin, major antidepressants;\n* Pregnancy, postpartum period (6 months), lactation or post-lactation period (6 months);\n* Absence of a reliable and effective method of contraception for a subject with childbearing potential;\n* Subjects who are currently receiving another investigational treatment or who had participated in another clinical investigation within 30 days prior to study enrollment;\n* A subject who suffer from another medical condition or who are receiving medication that in the Principal Investigator's judgment would prohibit the inclusion in the study;\n* Subject with limited mental activity and consistent comprehension ability; sportsmen and individuals on strenuous physical loading; prisoners;\n* Refusal to sign the Informed Consent Form."}, 'identificationModule': {'nctId': 'NCT04659668', 'briefTitle': 'Evaluation of the Efficacy and Safety of the Dermal Filler for Female Intimate Area Hydration and Atrophy of the Vagina.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mesoestetic Pharma Group S.L.'}, 'officialTitle': 'An Open-Label Uncontrolled Single Centre Study for the Evaluation of the Performance Characteristics (Efficacy and Safety) of the Dermal Filler MMG-23-04-2019 (Hyaluronic Acid 2,0%) for Female Intimate Area Hydration and Atrophy of the Vagina.', 'orgStudyIdInfo': {'id': 'MD/MMG-23-04-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MMG-23-04-2019', 'description': 'MMG-23-04-2019 is composed by sodium hyaluronate at concentration of 2% (20 mg/ml) with 1,4-Butanediol diglycidyl ether (BDDE) acting as a cross-linking agent, in aqueous solution at physiological pH. The filler of 1ml is administered once or twice depending on the individual necessity.', 'interventionNames': ['Device: MMG-23-04-2019']}], 'interventions': [{'name': 'MMG-23-04-2019', 'type': 'DEVICE', 'description': 'The dermal filler MMG-23-04-2019 is applied to the female intimate area (intramucosal administration) of vaginal vestibule, vaginal walls, clitoris, "G" spot.', 'armGroupLabels': ['MMG-23-04-2019']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1592', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Medical Centre Ramus', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mesoestetic Pharma Group S.L.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}