Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT04080869
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2019-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C014794', 'term': 'retinol palmitate'}, {'id': 'D014212', 'term': 'Tretinoin'}], 'ancestors': [{'id': 'D014801', 'term': 'Vitamin A'}, {'id': 'D012176', 'term': 'Retinoids'}, {'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': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The topical preparations are packed in non-identifiable jars and coded by a person who is not involved in the study the patient.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Prospective, split face comparative clinical study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2019-09-04', 'studyFirstSubmitQcDate': '2019-09-05', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions', 'timeFrame': 'at first and every 2 weeks during the 6-week treatment period from starting the topical application', 'description': 'counting the number of inflammatory, non-inflammatory and total lesions at first and every week during the treatment'}, {'measure': 'assessment of tolerability: interviewing the patients', 'timeFrame': 'every 2 weeks during the 6-week treatment period from starting the topical application', 'description': 'interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acne vulgaris', 'retinoids', 'retinyl palmitate', 'ethosomes'], 'conditions': ['Facial Acne Vulgaris']}, 'referencesModule': {'references': [{'pmid': '12842345', 'type': 'BACKGROUND', 'citation': 'Manconi M, Valenti D, Sinico C, Lai F, Loy G, Fadda AM. Niosomes as carriers for tretinoin. II. Influence of vesicular incorporation on tretinoin photostability. Int J Pharm. 2003 Jul 24;260(2):261-72. doi: 10.1016/s0378-5173(03)00268-0.'}, {'pmid': '18532922', 'type': 'RESULT', 'citation': 'Castro GA, Ferreira LA. Novel vesicular and particulate drug delivery systems for topical treatment of acne. Expert Opin Drug Deliv. 2008 Jun;5(6):665-79. doi: 10.1517/17425247.5.6.665.'}, {'pmid': '16247244', 'type': 'RESULT', 'citation': 'Date AA, Naik B, Nagarsenker MS. Novel drug delivery systems: potential in improving topical delivery of antiacne agents. Skin Pharmacol Physiol. 2006;19(1):2-16. doi: 10.1159/000089138.'}]}, 'descriptionModule': {'briefSummary': 'Acne is a chronic inflammatory dermatosis of the pilosebaceous unit. Topical treatment is the first choice in mild and moderate cases of acne, especially topical retinoids. Although topical retinoids are very effective in the treatment of acne, local cutaneous irritation including burning, itching, erythema, peeling or dryness, is observed in a considerable number of patients, resulting in low patient compliance, compromising the efficacy of the therapy.\n\nSeveral approaches have been proposed to address these concerns, including the use of esters of retinoic acid (RA) and RA precursors, such as retinol and retinaldehyde, or novel drug delivery systems, which present the potential for controlled release, in turn reducing the aforementioned occurrences.\n\nEncapsulation of retinoids into vesicular carriers as liposomes and ethosomes and nanoparticulate carriers can significantly improve their effects for the treatment of acne compared with commercial formulations , providing better tolerability of irritating retinoid.\n\nThe aim of work is to assess the efficacy and tolerability of the topical application of Retinyl Palmitate-loaded ethosome formulation in the treatment of acne vulgaris in comparison to conventional formulation of classic retinoids'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with facial mild to moderate acne vulgaris\n* Patients aged 12-40 years old\n\nExclusion Criteria:\n\n* Pregnant females\n* Patients with skin condition of the face such as rosacea, perioral dermatitis, atopic or seborrheic dermatitis or psoriasis.\n* Patients with known hypersensitivity to preparations containing retinoid.\n* Patients who take any other cocomitant systemic or topical medications for acne vulgaris'}, 'identificationModule': {'nctId': 'NCT04080869', 'briefTitle': 'Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Formulation of Retinyl Palmitate-loaded Topical Ethosomes for Treatment of Acne Vulgaris: a Split-face Comparative Clinical Study', 'orgStudyIdInfo': {'id': 'RP-AV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'retinyl palmitate ethosomes arm', 'description': 'All patients will be instructed to apply a thin film of the new formula on one side of the face', 'interventionNames': ['Drug: retinyl palmitate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tretinoin arm', 'description': 'All patients will be instructed to apply a thin film of topical retinoid cream on the other side of the face', 'interventionNames': ['Drug: Tretinoin']}], 'interventions': [{'name': 'retinyl palmitate', 'type': 'DRUG', 'otherNames': ['retinyl palmitate ethosomes'], 'description': 'topical retinyl palmitate loaded ethosomes', 'armGroupLabels': ['retinyl palmitate ethosomes arm']}, {'name': 'Tretinoin', 'type': 'DRUG', 'otherNames': ['classic retinoid'], 'description': 'topical tretinoin', 'armGroupLabels': ['tretinoin arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Sara M Awad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, Venereology and Andrology, Assiut University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'data that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sara Mohamed Awad', 'investigatorAffiliation': 'Assiut University'}}}}