Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT06821867
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2025-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of PN+HA (NEWEST) for the Improvement of Skin Hydration
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': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2025-01-30', 'studyFirstSubmitQcDate': '2025-02-11', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Global Aesthetic Improvement Scale (GAIS) from V4 to baseline completed by Investigator', 'timeFrame': 'At the enrollment and after 4 months from the last treatment.', 'description': 'To evaluate the performance of PN + HA (Newest) on the aesthetic appearance of the skin 4 months after the last treatment, the change in the Global Aesthetic Improvement Scale (GAIS), rated on a 5-point scale (1= very much/extremely improved; 2= much improved; 3= improved; 4= no change; 5= worse) from V4 to baseline (pre-treatment), will be assessed. The GAIS will be completed by the Investigator. The pre-treatment GAIS score (at baseline/V0) will be "4" for each treated area for all enrolled subjects.'}], 'secondaryOutcomes': [{'measure': 'Investigator and Subject GAIS at each visit', 'timeFrame': 'From enrollment to the end after 4 months from the last treatment (at each visit)', 'description': 'To evaluate the performance of PN + HA (Newest) on the aesthetic appearance of the skin, the change in the Global Aesthetic Improvement Scale (GAIS), rated on a 5-point scale (1= very much/extremely improved; 2= much improved; 3= improved; 4= no change; 5= worse), will be assessed at each visit. The GAIS will be completed independently by the Investigator and the Subject.'}, {'measure': 'Performance of PN + HA (Newest) on the skin hydration at each visit', 'timeFrame': 'From enrollment to the end after 4 months from the last treatment (at each visit)', 'description': 'To evaluate the performance of PN + HA (Newest) on skin hydration at each visit, the MoistureMeterEpiD, which displays percentage water content (0 - 100 %), will be used by the Investigator.'}, {'measure': 'Performance of PN + HA (Newest) on the skin elasticity at each visit', 'timeFrame': 'From enrollment to the end after 4 months from the last treatment (at each visit)', 'description': 'To evaluate the performance of PN + HA (Newest) on the skin elasticity at each visit, the ElastiMeter, which measures skin elasticity in N/m, will be used by the Investigator at each visit.'}, {'measure': 'Performance of PN + HA (Newest) on skin turgor at each visit', 'timeFrame': 'From enrollment to the end after 4 months from the last treatment (at each visit)', 'description': 'To evaluate the performance of PN + HA (Newest) on skin turgor at each visit, a 5-Likert scale (1 - Very poor, 2 - Poor, 3 - Good, 4 - Very good, 5 - Excellent) will be used by the Investigator at each visit.'}, {'measure': 'Pain intensity after injection of PN + HA (Newest)', 'timeFrame': 'During the injection procedures', 'description': 'To evaluate pain intensity after injection of PN + HA (Newest), a Numerical Rating Scale (NRS), a 0 to 10 scale indicating the degree of pain the patient experienced (0 - No Pain, 5 - Moderate Pain, 10 - Worst possible Pain), will be used at Visit 0 (Baseline), Visit 1 and Visit 2.'}, {'measure': 'Subject satisfaction with PN + HA (Newest)', 'timeFrame': '2 months after last treatment and 4 months after the last treatment', 'description': 'To evaluate subject satisfaction with PN + HA (Newest), a 5-Likert scale, from 1 to 5 indicating how satisfied is the patient (1 - Extremely dissatisfied, 5 - Extremely satisfied), will be used at Visit 3 and at End of study (Visit 4)'}, {'measure': 'Device deficiencies', 'timeFrame': 'During the injection procedures', 'description': 'A Device Deficiency (DD) is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer. This definition includes device deficiencies related to PN + HA (Newest). Any DD will be assessed by the Investigator at Baseline (Visit 0), Visit 1, and Visit 2.'}, {'measure': 'Adverse events, serious adverse events and concomitant medications monitoring', 'timeFrame': 'All visits from baseline to the last follow-up after 12 weeks from the end of the treatment', 'description': 'Adverse events, serious adverse events and concomitant medications will be monitored during the entire study duration. Subjects will receive a diary to record any deviation from the normal health status as well as any concomitant medication taken.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Skin hydration', 'Aesthetic improvement', 'Polynucleotides', 'PN HPT', 'Skin elasticity', 'Skin turgor', 'Mastelli'], 'conditions': ['Skin Hydration', 'Skin Elasticity']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'E. Bartoletti et al., "PN HPTTM and Striae Albae-Exploratory Interim Analysis of a Randomised Prospective Study, " Surgical Research, vol. 5, no. 3, Sep. 2023, doi: 10.33425/2689-1093.1057'}, {'pmid': '32799391', 'type': 'BACKGROUND', 'citation': 'Cavallini M, Bartoletti E, Maioli L, Massirone A, Pia Palmieri I, Papagni M, Priori M, Trocchi G; As Members of The Polynucleotides HPT Priming Board, Collegio Italiano delle Societa Scientifiche di Medicina Estetica (Italian College of the Aesthetic Medicine Scientific Societies) - SIME, AGORA, SIES. Consensus report on the use of PN-HPT (polynucleotides highly purified technology) in aesthetic medicine. J Cosmet Dermatol. 2021 Mar;20(3):922-928. doi: 10.1111/jocd.13679. Epub 2020 Sep 21.'}, {'pmid': '25224018', 'type': 'BACKGROUND', 'citation': 'De Caridi G, Massara M, Acri I, Zavettieri S, Grande R, Butrico L, de Franciscis S, Serra R. Trophic effects of polynucleotides and hyaluronic acid in the healing of venous ulcers of the lower limbs: a clinical study. Int Wound J. 2016 Oct;13(5):754-8. doi: 10.1111/iwj.12368. Epub 2014 Sep 16.'}, {'pmid': '33755110', 'type': 'BACKGROUND', 'citation': 'Araco A, Araco F. Preliminary Prospective and Randomized Study of Highly Purified Polynucleotide vs Placebo in Treatment of Moderate to Severe Acne Scars. Aesthet Surg J. 2021 Jun 14;41(7):NP866-NP874. doi: 10.1093/asj/sjab125.'}, {'pmid': '38371328', 'type': 'BACKGROUND', 'citation': 'Lim TS, Liew S, Tee XJ, Chong I, Lo FJ, Ho MJ, Ong K, Cavallini M. Polynucleotides HPT for Asian Skin Regeneration and Rejuvenation. Clin Cosmet Investig Dermatol. 2024 Feb 13;17:417-431. doi: 10.2147/CCID.S437942. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': "This is a post-market, monocentric, interventional, single-arm, confirmative clinical investigation to evaluate the performance and the safety of PN+HA (NEWEST) for the improvement of skin hydration.\n\nEach Subject, after signing the Informed Consent Form (ICF), will enter into a screening/baseline phase during which the baseline tests will be conducted. The Subject can be treated immediately after signing the ICF.\n\nFor each Subject, 5 visits will be planned during which several assessments will be performed as described in the Flowchart:\n\n* V0 (Screening/baseline): Day 0, when the first IP injection will be performed;\n* V1: 2 weeks ± 7 days from V0, when the second IP injection will be performed;\n* V2: 2 weeks ± 7 days from V1, when the third IP injection will be performed (End Of Treatment/EOT);\n* V3: maximum 4 months from V0 and 2 months after the last IP injection (V2);\n* V4: maximum 6 months form V0 and 4 months after the last IP injection (V2).\n\nAt V0, the Investigator will collect demographic data (e.g., gender, age, skin phototype according to Fitzpatrick's classification), medical history (e.g., history of autoimmune disease, diabetes, etc.), drug allergy history of the enrolled Subject.\n\nAt V0, V1, and V2 according to the instructions for use (IFU), the enrolled Subjects will be treated with PN+HA in maximum 2 areas of the face, or 1 area of the face plus neck/décolleté/back of the hands, making sure that at least 10 areas of face, neck, décolleté and back of the hands will be reached.\n\nLocal anesthetics containing lidocaine may be used in order to guarantee the necessary comfort to the Subject.\n\nPerformance will be evaluated by the Investigator using the Global Aesthetic Improvement Scale (GAIS) at each visit. The GAIS will be independently completed by the Investigator and the Subject. Photographs with a 2D camera will be taken at each visit. Skin hydration will be assessed by using the MoistureMeterEpiD (at least three measurements will be obtained per each area treated) at each visit.\n\nSkin elasticity will be evaluated using the ElastiMeter (at least three measurements will be obtained per each area treated) at each visit.\n\nSkin turgor will be assessed by the Investigator using a 5-Likert scale at each visit.\n\nAt V0, V1 and V2 after injection, the Investigator will record Subjects' pain intensity using the Numerical Rating Scale (NRS).\n\nSubject satisfaction with treatment will be evaluated with a 5-point Likert Scale at V3 and EOS visit (V4).\n\nSafety will include evaluation of possible cutaneous reactions at each visit. Adverse events, concomitant medications, and device deficiencies will be monitored during the entire duration of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject Informed consent form (ICF) signed;\n2. Female and male Subjects aged 18-70 years;\n3. Subjects desiring improvement of skin hydration in maximum 2 areas of the face, or 1 area of the face plus neck or décolleté;\n4. Healthy skin;\n5. Willingness to discontinue all dermatological treatment and procedures during the study;\n6. Willingness to follow all study procedures, including attending all site visits, tests and examinations;\n7. Agreeing to present at each study visit without face/neck/ décolleté cosmetics;\n8. Accepting to not change their habits regarding food, physical activity, face/neck/décolleté cosmetics and cleansing products;\n9. Willingness to follow indications to minimize exposure of the treated area to too much sunlight or extreme cold, at least until the papules have completely subsided;\n10. Skin phototype I-IV according to Fitzpatrick's classification.\n\nExclusion Criteria:\n\n1. Other - different - clinical conditions of the skin (i.e. rosacea, psoriasis, vitiligo, active eczema, severe scleroderma, severe acne and diagnosticated cancer with/without ongoing antitumor therapy);\n2. Infectious or inflammatory processes near the area of intervention;\n3. Presence of cutaneous disease on the tested area, as malformations and recurrent facial/labial herpes;\n4. Presence of tendon, bone or muscular implants near the area of intervention;\n5. Ongoing cutaneous allergies;\n6. Allergy or contraindications to device components;\n7. Concomitant intake of anticoagulant or antiplatelet medications;\n8. Subjects who have not followed a washout period of 2 weeks from topical corticosteroids, antibiotics, benzoyl-peroxide, azelaic acid, hydroxy acids, topical retinoids;\n9. Immune system illnesses/disease;\n10. Uncontrolled diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder);\n11. Treatment with substances which act on blood fluidity (eg. Aspirin, NSAIDs, Vitamin E), or drugs able to influence the test results in the investigator opinion, within 5 days prior to study inclusion;\n12. Known drug and/or alcohol abuse;\n13. Mental incapacity that precludes adequate understanding or cooperation;\n14. Any previous permanent and non-permanent cutaneous treatment for aesthetic correction (biomaterial implant, lifting, laser, botulinum toxin injections, chemical peeling, fillers) of the treated area within 6 months prior to study inclusion;\n15. Pregnancy or breastfeeding;\n16. Participation in another investigational study within 1 month prior to study inclusion."}, 'identificationModule': {'nctId': 'NCT06821867', 'briefTitle': 'Efficacy and Safety of PN+HA (NEWEST) for the Improvement of Skin Hydration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mastelli S.r.l'}, 'officialTitle': 'A Post-market, Monocentric, Interventional, Single-arm, Confirmative Clinical Investigation to Evaluate the Performance and the Safety of PN+HA (NEWEST) for the Improvement of Skin Hydration', 'orgStudyIdInfo': {'id': 'M-PNHA-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'interventionNames': ['Device: PN + HA (Newest)']}], 'interventions': [{'name': 'PN + HA (Newest)', 'type': 'DEVICE', 'description': 'PN+HA (Newest) is a viscoelastic, sterile, single-use gel for intradermal use. PN+HA is a medical device containing the combination of polynucleotides (10 mg/ml) and hyaluronic acid (10 mg/ml).\n\nPN+HA is administered using a fine needle (usually 30 G) by injecting the solution into the dermis. Depending on the medical assessment, different injection techniques such as linear threading, serial punctures, crosslinked, radial fanning or mixed can be used. The injection site must consist of healthy skin. PN+HA can also be administered by means of non-invasive techniques (iontophoresis, electroporation, hydroelectrophoresis, etc.). In all these cases, thoroughly cleanse and disinfect the area to be treated before application. Then remove the disinfectant with sterile saline.', 'armGroupLabels': ['Treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16132', 'city': 'Genova', 'state': 'Italy', 'country': 'Italy', 'facility': 'Clinica di Chirurgia plastica e ricostruttiva/Ospedale Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mastelli S.r.l', 'class': 'INDUSTRY'}, 'collaborators': [{'name': '1Med', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}