Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 10:54 PM
Study NCT ID:
NCT06844760
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2025-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed Company) in the Neck Area
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': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2025-02-08', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin elasticity measured with Cutometer', 'timeFrame': 'weeks 8 and 16', 'description': 'Change of elasticity parameters (R0, R2, and R5) at weeks 8 and 16 from the baseline visit'}], 'secondaryOutcomes': [{'measure': 'Stratum corneum moisture', 'timeFrame': 'weeks 8 and 16', 'description': 'Change of stratum corneum moisture measured by MPA 580 probes in the neck area at weeks 8 and 16 from the baseline visit'}, {'measure': 'Transepidermal Water Loss (TEWL)', 'timeFrame': 'weeks 8 and 16', 'description': 'Change of TEWL measured by MPA 580 probes in the neck area at weeks 8 and 16 from the baseline visit'}, {'measure': 'General neck condition', 'timeFrame': 'weeks 8 and 16', 'description': 'Improvement in the clear lines and wrinkles of the neck area according to the Institut Biochimique SA (IBSA) Neck Laxity Scale, with grade 1 being normal tissue tone without noticeable laxity and grade 5 being severe laxity with extreme sagging, using before and after photos, by an independent physician'}, {'measure': 'Skin aging', 'timeFrame': 'weeks 8 and 16', 'description': 'Improvement in the clear lines and wrinkles of the neck area according to global aesthetic improvement scale (GAIS), with grade 1 being exceptional improvement and grade 5 being worsened, using before and after photos by an independent physician'}, {'measure': 'Pain intensity', 'timeFrame': 'Day 0 and week 4', 'description': 'Pain intensity using the VAS (visual analogue scale) \\[from 0 (complete painlessness) to 10 (maximum pain imaginable)\\].'}, {'measure': 'Participant satisfaction', 'timeFrame': 'weeks 8 and 16', 'description': 'Participant satisfaction by using the VAS \\[from 0 (complete dissatisfaction) to 10 (complete satisfaction)\\].'}, {'measure': 'Participant evaluation', 'timeFrame': 'weeks 8 and 16', 'description': 'Evaluation of participants on the improvement of their skin condition in terms of increased hydration, firmness and radiance, by a questionnaire designed by us. The questionnaire consists of five yes-or-no questions.'}, {'measure': 'Safety assessment', 'timeFrame': 'Day 0 and weeks 4, 8, 16', 'description': 'Assessment of adverse events following treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Aging']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the safety and effectiveness of stabilized Hyaluronic Acid Injection under the brand name Perleux body for neck skin rejuvenation, elasticity improvement, and hydration enhancement.\n\nPrimary objective: Elasticity (R0, R2, and R5) improvement from baseline in neck area at weeks 8 and 16 Hypothesis: Perleux body (produced by Espad Pharmed Co.) has acceptable efficacy and safety profile for neck skin rejuvenation, elasticity improvement, and hydration enhancement.\n\nSecondary objectives: Effectiveness and safety assessment of Perleux body Study design: This is a phase IV, single-arm, and pre-post study Setting: Subjects will be treated with 2cc of Perleux body at baseline. After 4 weeks, a touch-up injection will be performed to achieve optimal improvement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 35 and 60 years (inclusive)\n* The presence of visible signs of skin aging, mainly dry neck skin, rough neck skin, loss of elasticity and clear lines and wrinkles (grades 2, 3, and 4 based on the IBSA Neck Laxity Scale)\n* Able to follow study instructions and likely to complete all required visits\n* Signing the informed consent form and agreeing to the 6-month follow-up\n\nExclusion Criteria:\n\n* Previous treatment with fillers containing hyaluronic acid in the neck area during the last year\n* History of using RF, rejuvenating lasers or intense pulsed light in the last 6 months\n* Having systemic diseases that affect skin health, such as vascular collagen diseases, diabetes, hypothyroidism, liver and kidney failure.\n* History of systemic use of drugs affecting the skin such as glucocorticoids, isotretinoin, immunomodulators and hormonal drugs in the last 3 months\n* History of taking supplements containing collagen, hyaluronic acid and vitamin C in the last 3 months\n* History of using topical corticosteroids and retinoids in the last 4 weeks\n* Using topical cosmetic products containing anti-aging ingredients in the last 2 weeks\n* Pregnant and lactating women\n* History of active smoking during the last 2 years\n* Major change in lifestyle including diet and physical activities and sun exposure during the study\n* History of previous allergy to hyaluronic acid or lidocaine\n* Any inflammation, active infection, unhealed old wound, and skin lesions in the injection area\n* Using any anticoagulant product, NSAID, or any other drug that increases the risk of coagulation disorders, in the last 7 days\n* History of anaphylactic shock\n* Being prone to hypertrophic scar formation\n* History of autoimmune disease or immune deficiency or using immunosuppressant drugs'}, 'identificationModule': {'nctId': 'NCT06844760', 'briefTitle': 'Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed Company) in the Neck Area', 'organization': {'class': 'INDUSTRY', 'fullName': 'Espad Pharmed'}, 'officialTitle': 'Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed Company) in the Rejuvenation, Hydration, and Elasticity Improvement of the Neck Area', 'orgStudyIdInfo': {'id': 'PERB.ESP.VL.IV.03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Perleux body', 'interventionNames': ['Device: Hyaluronic Acid (HA)']}], 'interventions': [{'name': 'Hyaluronic Acid (HA)', 'type': 'DEVICE', 'description': 'Subjects will be treated with 2cc of Perleux body at baseline. After 4 weeks, a touch-up injection will be performed to achieve optimal improvement.', 'armGroupLabels': ['Perleux body']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Private Clinic', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Espad Pharmed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}