Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-03-03 @ 12:02 AM
Study NCT ID:
NCT03273504
Status:
COMPLETED
Last Update Posted:
2018-01-09
First Post:
2017-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006983', 'term': 'Hypertrichosis'}], 'ancestors': [{'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, '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': '2017-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-08', 'studyFirstSubmitDate': '2017-09-04', 'studyFirstSubmitQcDate': '2017-09-04', 'lastUpdatePostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of the hair density', 'timeFrame': 'Baseline (T0), 1 month (T1), 3 months (T3)', 'description': 'Hair density (hair number/mm2) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)'}, {'measure': 'Change from baseline of the percentage of terminal hair', 'timeFrame': 'Baseline (T0), 1 month (T1), 3 months (T3)', 'description': 'Percentage of terminal hair (terminal hair has a diameter \\>0.04 mm) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)'}, {'measure': 'Change from baseline of the percentage of vellus hair', 'timeFrame': 'Baseline (T0), 1 month (T1), 3 months (T3)', 'description': 'Percentage of vellus hair (terminal hair has a diameter \\<0.04 mm) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)'}, {'measure': 'Change from baseline of hair regrowth speed', 'timeFrame': 'Baseline (T0), 1 month (T1), 3 months (T3)', 'description': 'Hair regrowth speed (mm/die) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline of superficial skin hydration', 'timeFrame': 'Baseline (T0), 1 month (T1), 3 months (T3)', 'description': 'Skin electrical capacitance value is measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany).\n\nThe measure of the skin capacitance properties is an indirect expression of its hydration level.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertrichosis']}, 'descriptionModule': {'briefSummary': 'Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the activity on hair regrowth of a topical cosmetic product versus placebo (comparison within subjects)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n* female sex\n* with hypertrichosis\n* agreeing not to perform epilation or scrub/peeling treatment on the test area (legs) during the week preceding the inclusion\n* good general state of health\n\nExclusion Criteria:\n\n* pregnancy\n* lactation\n* subjects whose insufficient adhesion to the study protocol is foreseeable\n* sensitive skin\n* oral contraceptive therapy started less than 1 year\n* presence of varicose or capillary veins of surface\n* hormonal therapies able to influence hair growth.\n* presence of cutaneous disease on the tested area, as lesions, scars, malformations.\n* diabetes\n* endocrine disease\n* hepatic disorder\n* renal disorder\n* cardiac disorder\n* cancer.\n* farmacological topical treatment and surgery and/or medical treatment on the treated side performed in the last 3 months\n* systemic corticosteroids\n* aspirin or non-steroid anti-inflammatory drugs (FANS)\n* diuretic.'}, 'identificationModule': {'nctId': 'NCT03273504', 'briefTitle': 'Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo', 'organization': {'class': 'OTHER', 'fullName': 'Derming SRL'}, 'officialTitle': 'Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo', 'orgStudyIdInfo': {'id': 'E1517'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)', 'description': 'Comparison within subjects of Actapil Corpo Spray versus Placebo. The study product will be applied twice a dayon the right or left leg (tibialis area) according to a randomisation list.\n\nThe placebo product will be applied in the same way, on the controlateral leg.', 'interventionNames': ['Other: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)', 'Other: Placebo']}], 'interventions': [{'name': 'Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)', 'type': 'OTHER', 'description': 'The study product will be applied twice a day (at morning and at evening) for an interrupted period of 3 months, on the right or left leg (tibialis area) according to a randomisation list.', 'armGroupLabels': ['Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'The placebo product will be applied twice a day (at morning and at evening) for an interrupted period of 3 months, on the controlateral leg (tibialis area) right or left leg according to a randomisation list.', 'armGroupLabels': ['Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20149', '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': 'Dermatologist, Principal Investigator', 'investigatorFullName': 'Adele Sparavigna', 'investigatorAffiliation': 'Derming SRL'}}}}