Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-07-06 @ 2:52 PM
Study NCT ID:
NCT04835259
Status:
UNKNOWN
Last Update Posted:
2021-04-20
First Post:
2021-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Topical Antioxidants in Tretment of Photoaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012176', 'term': 'Retinoids'}, {'id': 'C007288', 'term': 'dexpanthenol'}], 'ancestors': [{'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-18', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-04-04', 'lastUpdatePostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in Dermoscopy photoaging scale', 'timeFrame': 'assesed every month for 6 months', 'description': 'Dermoscopy photoaging scale (DPAS) is a reliable and valid diagnostic tool that can evaluate photoaged skin quantitatively by the help of objective criteria. It can be used to evaluate the effect of preventive and therapeutic applications for skin aging.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['topical antioxidants', 'photoaged skin'], 'conditions': ['Photoaging']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial study aims at investigating the efficacy and safety of topical antioxidants in treatment of a cohort of non-elderly volunteers with photoaged skin.', 'detailedDescription': '•Sample size calculation: The sample size was assessed prospectively using Openepi version 3.01 to provide a 80% power to detect a 40-50% difference before and after treatment using either topical antioxidants or retinoids with a significance level of 0.05 (based on the results of a previous clinical trial). Assuming 10% dropout, 30 patients will be recruited in each treatment group.\n\n•Statistical analysis: Data will be collected and recorded on excel data sheet. Data will be tested for normality. Quantitative data will be represented as mean and standard deviation, or median and interquartile range. Qualitative data will be presented as number and percentage. The relevant statistical method will be used for comparison. P value will be considered statistically significant if it is less than 0.05'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult volunteers \\< 50 years old\n* Clinical and dermoscopic features of photoaging.\n\nExclusion Criteria:\n\n* Genodermatoses associated with photosensitivity.\n* Treatment by medications affecting skin aging (eg, topical and systemic retinoids) in the last 6 months prior to enrollment.\n* Any recent cosmetic procedures.'}, 'identificationModule': {'nctId': 'NCT04835259', 'briefTitle': 'Efficacy of Topical Antioxidants in Tretment of Photoaging', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Efficacy of a Combination of Topical Antioxidants in Tretment of Photoaged Skin:A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Soh-Med-21-01-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1(treatment group)', 'description': 'Topical application of a cream of a combination of antioxidants once daily at night for 6 months Name: Selenium ACE cream (Interpharma UK company, Egypt)\n\nIngredients:\n\nSelenium (Selenium amino acid chelate) 0.5% Vitamin C (Sodium ascorbyl phosphate - stay C) %1 Vitamin E (Tocopheryl acetate) % 0.5 Vitamin A (Retinyl palmitate) %1 Emulsifiers ( Ceteareth 20 , Glycerol monostearate , Cetyl alcohol) Emollient(Caprylic capric triglycerides)', 'interventionNames': ['Drug: Selenium Amino Acid Chelate (Selenium ACE cream)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 (positive control)', 'description': 'Topical application of a retinoid (tretinoin 0.05%) cream once daily at night for 6 months (Acretin 0.05% cream Jamjoom pharmaceuticals, Egypt)', 'interventionNames': ['Drug: Selenium Amino Acid Chelate (Selenium ACE cream)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 3 (Negative control)', 'description': 'Topical application of a panthenol cream once daily at night for 6 months (panthenol 2% cream, El Nile company, Egypt)', 'interventionNames': ['Drug: Selenium Amino Acid Chelate (Selenium ACE cream)']}], 'interventions': [{'name': 'Selenium Amino Acid Chelate (Selenium ACE cream)', 'type': 'DRUG', 'otherNames': ['topical retinoid (Acretin 0.05% cream)', 'topical panthenol (Panthenol cream)'], 'description': 'application of a topical agent over the whole face for 6 months', 'armGroupLabels': ['Group 1(treatment group)', 'Group 2 (positive control)', 'Group 3 (Negative control)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'esraa ismail', 'role': 'CONTACT', 'email': 'esraasalah123@yahoo.com', 'phone': '00201000509636'}], 'overallOfficials': [{'name': 'esraa ismail', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'esraa ismail', 'investigatorAffiliation': 'Sohag University'}}}}