Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-02-23 @ 1:10 AM
Study NCT ID:
NCT03279159
Status:
COMPLETED
Last Update Posted:
2017-09-12
First Post:
2017-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydrating Efficacy and Tolerance Evaluation of a Face Cream
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': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-08', 'studyFirstSubmitDate': '2017-09-04', 'studyFirstSubmitQcDate': '2017-09-08', 'lastUpdatePostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of superficial skin hydration after a single product application', 'timeFrame': 'Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)', 'description': 'Variation of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany) after a single product application on the skin area damaged by corneum stripping'}, {'measure': 'Change of transepidermal water loss (TEWL) after a single product application', 'timeFrame': 'Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)', 'description': 'Variation of transepidermal water loss value measured with Tewameter® TM300 (MPA 5 Courage-Khazaka, Germany) after a single product application on the skin area damaged by corneum stripping'}, {'measure': 'Change of superficial skin hydration after repeated product application', 'timeFrame': 'Baseline (T0), 4 weeks (T4), 8 weeks (T8)', 'description': 'Variation of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany) after repeated product application on the face'}, {'measure': 'Change of deep skin hydration after repeated product application', 'timeFrame': 'Baseline (T0), 4 weeks (T4), 8 weeks (T8)', 'description': 'Variation of tissue dielectric constant value of deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland) after repeated product application on the face'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry and Damaged Skin']}, 'descriptionModule': {'briefSummary': 'Aim of the study was to evaluate by non-invasive instrumental evaluations tolerance and hydrating activity of a face topic product, to be applied twice a day, morning and evening, for an uninterrupted period of 8 weeks, by volunteers of both sexes, aged 45-60, who meet the inclusion and exclusion criteria required by the study procedure .\n\nIt was also aim of this study to evaluate the hydrating activity of a single product application on the skin damaged by repeated stripping corneum (short term evaluation versus untreated control area).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both sexes,\n* age 45-60 years,\n* caucasian subjects,\n* agreeing to present at each study visit without make-up,\n* accepting to follow the instructions received by the investigator,\n* accepting to not change their habits regarding food, physical activity, face cleansing and make- up use,\n* agreeing not to apply or take any product or use face massages or other means known to improve skin wrinkle and skin qualities during the entire duration of the study,\n* accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study,\n* no participation in a similar study currently or during the previous 3 months\n* accepting to sign the Informed consent form.\n\nExclusion Criteria:\n\n* Pregnancy (only for female subjects),\n* lactation (only for female subjects),\n* sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit),\n* subjects whose insufficient adhesion to the study protocol is foreseeable.\n* presence of cutaneous disease on the tested area as lesions, scars, malformations,\n* recurrent facial/labial herpes,\n* clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).\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* anti-inflammatory drugs, anti-histaminic, topic (application on the face) and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of hormonal treatment starting more than 1 year ago),\n* using of drugs or dietary supplements able to influence the test results in the investigator opinion.'}, 'identificationModule': {'nctId': 'NCT03279159', 'briefTitle': 'Hydrating Efficacy and Tolerance Evaluation of a Face Cream', 'organization': {'class': 'OTHER', 'fullName': 'Derming SRL'}, 'officialTitle': 'Hydrating Efficacy and Tolerance Evaluation of a Face Cream', 'orgStudyIdInfo': {'id': 'E0617'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jaluronius CS cream (Difa Cooper S.p.a, Italy)', 'interventionNames': ['Other: Jaluronius CS cream short term evaluation', 'Other: Jaluronius CS cream long term evaluation']}], 'interventions': [{'name': 'Jaluronius CS cream short term evaluation', 'type': 'OTHER', 'description': 'Short term evaluation to investigate the hydrating activity of a single application of the study product on the forearms (volar surface) after repeated stripping procedure,measured immediately after stripping execution (T0i), 1,8 and 24 hour/s after product application (T1h, T8h and T24h).', 'armGroupLabels': ['Jaluronius CS cream (Difa Cooper S.p.a, Italy)']}, {'name': 'Jaluronius CS cream long term evaluation', 'type': 'OTHER', 'description': 'Long term evaluation to investigate the hydrating activity of the repeated application of the study product on the face (twice a day, for an uninterrupted period of 8 weeks), measured at basal visit (T0) and after 4 and 8 week-treatment (T4, T8)', 'armGroupLabels': ['Jaluronius CS cream (Difa Cooper S.p.a, Italy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20900', 'city': 'Monza', 'state': 'Monza-brianza', 'country': 'Italy', 'facility': 'DERMING', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Derming SRL', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dermatologist, Principal Investigator', 'investigatorFullName': 'Adele Sparavigna', 'investigatorAffiliation': 'Derming SRL'}}}}