Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-30 @ 4:48 AM
Study NCT ID:
NCT04239768
Status:
COMPLETED
Last Update Posted:
2020-01-30
First Post:
2020-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of an Antiage Aesthetic Treatment for the Middle and Inferior Third of the Face
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-28', 'studyFirstSubmitDate': '2020-01-21', 'studyFirstSubmitQcDate': '2020-01-21', 'lastUpdatePostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wrinkle Severity Rating Scale (WSRS) grade variation', 'timeFrame': 'Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)', 'description': 'Reduction of wrinkles severity corresponding to a decrease from the baseline of the Wrinkle Severity Rating Scale (WSRS) clinical score where:\n\nGrade 1 (absent): no visible nasolabial fold; continuous skin line. Grade 2 (mild): shallow but visible nasolabial fold with a slight indentation; minor facial feature.\n\nGrade 3 (moderate): moderately deep nasolabial folds; clear facial feature visible at normal appearance but not when stretched.\n\nGrade 4 (severe): very long and deep nasolabial folds; prominent facial feature; \\<2mm visible fold when stretched.\n\nGrade 5 (very severe): extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched.'}, {'measure': 'Facial Volume Loss Scale (FVLS) grade variation', 'timeFrame': 'Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)', 'description': 'Reduction of face volume loss corresponding to a decrease from the baseline of the Facial Volume Loss Scale (FVLS) where:\n\nGrade 1: Mild flattening or shadowing of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). No prominent bony landmarks. No visibility of underlying musculature.\n\nGrade 2: An intermediate point between grade 1 and grade 3. Grade 3: Moderate concavity of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas. Prominence of bony landmarks. May have visibility of underlying musculature.\n\nGrade 4: An intermediate point between grade 3 and grade 5. Grade 5: Severe indentation of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). Severe prominence of bony landmarks. Clear visibility of underlying musculature.'}, {'measure': 'Photographic documentation (3D pictures)', 'timeFrame': 'Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)', 'description': 'Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system.'}, {'measure': 'Face volume variation', 'timeFrame': 'Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)', 'description': 'Face volume image analysis was carried on the 3D pictures taken by Vectra H1 thanks to Vectra analysis module (VAM) software'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Face Skin Laxity']}, 'descriptionModule': {'briefSummary': 'Primary endpoint of the study is to evaluate clinically and by non-invasive instrumental evaluations the aesthetic performance, on the third middle and inferior of the face, of "MonoDermà HA Bio-revitalizing gel", an intradermal filler containing hyaluronic acid, combined to a low level laser therapy (LLLT) to obtain a stable photo-cross-linking effect inside the dermis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* female sex;\n* Caucasian race;\n* non smokers;\n* no alcohol abuse and/or drug use;\n* 40-65 years;\n* FVLS 2-4 ;\n* available and able to return to the study site for the post-procedural follow-up examinations;\n* accepting not to change their habits regarding food, physical activity, cosmetic and cleansing products for the face;\n* accepting not to expose their face to strong UV irradiation (UV session and/or sun bathes) during the entire duration of the study, without appropriate sun protection;\n* accepting to sign the informed consent form.\n\nExclusion Criteria:\n\n* Pregnancy (only for female subjects not in menopause);\n* lactation (only for female subjects not in menopause);\n* smokers;\n* alcohol abuse and/or drug use;\n* female subjects not in menopause, who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;\n* female subjects not in menopause, who do not accept to perform the pregnancy test at T0 and T1 (before the 1st and the 2nd aesthetic procedure);\n* Body Mass Index (BMI) variation (± 1) during the study period;\n* having performed face treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 6 months beginning of the study;\n* having used permanent filler in the past;\n* change in the normal habits regarding food, physical activity, face cosmetic, cleansing and make-up use during the month preceding the test;\n* sensitivity to the test filler or its ingredients, including delayed hypersensitivity to hyaluronic acid and granulomatous reactions (to be assessed by the investigator during the baseline);\n* subjects whose insufficient adhesion to the study protocol is foreseeable;\n* participation in a similar study currently or during the previous 9 months;\n* dermatitis;\n* presence of cutaneous disease on the tested area, as lesions, scars, malformations;\n* subjects that tend to develop hypertrophic scars;\n* recurrent facial/labial herpes;\n* clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne);\n* diabetes;\n* endocrine disease;\n* hepatic disorder;\n* renal disorder;\n* cardiac disorder;\n* pulmonary disease;\n* cancer;\n* neurological or psychological disease;\n* inflammatory/immunosuppressive disease;\n* drug allergy;\n* anticoagulants and antiplatelet drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment started more than 1 year ago);\n* using of drugs able to influence the test results in the investigator's opinion."}, 'identificationModule': {'nctId': 'NCT04239768', 'briefTitle': 'Efficacy of an Antiage Aesthetic Treatment for the Middle and Inferior Third of the Face', 'organization': {'class': 'OTHER', 'fullName': 'Derming SRL'}, 'officialTitle': 'Efficacy and Tolerance Evaluation of an Antiage Aesthetic Treatment for the Middle and Inferior Third of the Face', 'orgStudyIdInfo': {'id': 'E0919'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MonoDermà HA gel combined to a low level laser', 'description': '"Monodermà HA Bio-revitalizing gel" is a sterile, biodegradable, isotonic intradermal filler produced by Innate S.r.l. (Italy) and distributed by Giuliani S.p.A. (Italy) in non-pyrogenic pre-filled syringe of 2 ml containing 2% (20mg/ml) of medium chain (1.0-1.5 x 106 Dalton) hyaluronic acid (HA), obtained from bacterial fermentation, in a physiologic buffer (see Appendix 1) and used as a filler for the correction of deep skin sagging and roughness.', 'interventionNames': ['Device: MonoDermà HA gel combined to a low level laser']}], 'interventions': [{'name': 'MonoDermà HA gel combined to a low level laser', 'type': 'DEVICE', 'description': 'Two intradermal injections of the filler were performed during the basal and after 1 month, on the middle and inferior third of the face (1ml for each face side) using a needle (30G).\n\nImmediately after both injection procedures, LLLT session were performed on the same face area for a total of 8 minutes, using three different wavelengths (450 nm, 650 nm and 1064 nm) simultaneously.', 'armGroupLabels': ['MonoDermà HA gel combined to a low level laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20159', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'DERMING', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Derming SRL', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Adele Sparavigna', 'investigatorAffiliation': 'Derming SRL'}}}}