Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-27 @ 3:49 AM
Study NCT ID:
NCT06384092
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2024-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Process Validation in Dermatology: Assessing Methods for UV Exposure (Artificial Source vs. Sunlight) and Efficacy Evaluation of Anti-Tanning Agents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010859', 'term': 'Pigmentation Disorders'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Proof of science/concept'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2024-02-06', 'studyFirstSubmitQcDate': '2024-04-22', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Melanine index using instrumental assessment', 'timeFrame': 'Days 1, 3 and 7.', 'description': 'Change in melanin index (MI) before and after the exposure as measured using the Changes in melanin index will be measured by using Mexameter® MX 18.'}, {'measure': 'Change in erythema index using instrumental assessment', 'timeFrame': 'Days 1, 3 and 7.', 'description': 'Change in the erythema index (EI) before and after the exposure as measured using the Mexameter® MX 18.'}], 'secondaryOutcomes': [{'measure': 'Change in skin erythema/dryness/wrinkles and oedema using draize scale', 'timeFrame': 'Days 1, 3 and 7.', 'description': 'Visual change in skin erythema/dryness/wrinkles and oedema of the skin using the Draize scale. Where 0=No reaction, 4=severe erythema/wrinkle/oedema'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Pigmentation']}, 'descriptionModule': {'briefSummary': 'The rationale of this study is to establish a robust method for assessing sun protection product efficacy in preventing erythema and tanning. Employing both artificial ultraviolet-A Irradiation and natural direct sunlight exposure, the investigation seeks to provide a reliable methodology, ensuring reproducibility and enabling a direct comparison between these methods. Meticulously determining optimal UV dosages, the study prioritizes inducing skin responses for evaluation while avoiding adverse effects like blistering. The localized validation of UV exposure techniques, tailored to the Indian population, contributes significantly to the field by addressing diverse skin types and environmental conditions. By incorporating both artificial and natural (direct sunlight) UV exposure methods, the study aspires to enhance the safety and effectiveness of future dermatological investigations, benefiting both the scientific community and the broader population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 06 Healthy adult subjects aged between 18 to 45 years (both inclusive).\n2. Healthy adult male and non-pregnant\\|non-lactating females.\n3. Female of childbearing potential have self-reported negative urine pregnancy test.\n4. Subjects with Fitzpatrick skin types III to V will be included. Alternatively, subjects with a Skin colorimetric Individual Typology Angle (ITA) value ranging from 20° to 41° at the application site (forearms) to be included to ensure a diverse representation of skin tones.\n5. Absence of known photosensitivity disorders to maintain the integrity of the study outcomes.\n6. Subjects must exhibit a willingness to comply with study plan, including follow-up visits and product applications.\n7. No history of skin cancer to or any adverse skin conditions, and not under any medication(s) likely to interfere with the study results.\n8. Subjects willing to follow study direction and willing to give written informed consent for the participation.\n\nExclusion Criteria:\n\n1. Active skin diseases, such as eczema or psoriasis, that could potentially influence skin reactions.\n2. Use of photosensitizing medications that interfere with UV-induced skin responses.\n3. Pregnancy or breastfeeding status, as hormonal changes during these periods can affect skin reactions.\n4. Individuals with a history of severe adverse reactions to skincare or cosmetic products, ensuring participant safety.\n5. Presence of open wounds, infections, or cuts at the application sites to prevent complications during the study.\n6. Subjects with a history of significant sunburns in the past three months, minimizing the potential for confounding effects.'}, 'identificationModule': {'nctId': 'NCT06384092', 'briefTitle': 'Process Validation in Dermatology: Assessing Methods for UV Exposure (Artificial Source vs. Sunlight) and Efficacy Evaluation of Anti-Tanning Agents', 'organization': {'class': 'OTHER', 'fullName': 'NovoBliss Research Pvt Ltd'}, 'officialTitle': 'Standardization of UV Exposure Methods (Artificial Source vs. Sunlight) in Dermatological Research: A Comprehensive Investigation Into the Efficacy Assessment Methodology for Anti-tanning Agents Through Process Validation', 'orgStudyIdInfo': {'id': 'NB240005-NB-V'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Site T1', 'description': 'Test Product A - Test Sun Protection Cream Dosage Form - Cream Route of Administration - Topical Mode of Usage - Apply directly on the designated site till absorbed. Dosage - 0.2 mL/site', 'interventionNames': ['Other: Test Sun Protection Cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Site T2', 'description': 'Test Product B - Benchmark (Sun Protection Cream) Dosage Form - Cream Route of Administration - Topical Mode of Usage - Apply directly on the designated site till absorbed. Dosage - 0.2 mL/site', 'interventionNames': ['Other: Benchmark Sun Protection Cream']}, {'type': 'NO_INTERVENTION', 'label': 'Site U1-4', 'description': 'Test Product : No test product applied.'}], 'interventions': [{'name': 'Test Sun Protection Cream', 'type': 'OTHER', 'otherNames': ['Test Treatment A'], 'description': 'Apply directly on the designated site till absorbed.', 'armGroupLabels': ['Site T1']}, {'name': 'Benchmark Sun Protection Cream', 'type': 'OTHER', 'otherNames': ['Test Treatment B'], 'description': 'Apply directly on the designated site till absorbed.', 'armGroupLabels': ['Site T2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '382421', 'city': 'Gandhinagar', 'state': 'Gujarat', 'country': 'India', 'facility': 'NovoBliss Research Pvt Ltd', 'geoPoint': {'lat': 23.21667, 'lon': 72.68333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NovoBliss Research Pvt Ltd', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator - Director (Operations)', 'investigatorFullName': 'Maheshvari Patel', 'investigatorAffiliation': 'NovoBliss Research Pvt Ltd'}}}}