Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT05913102
Status:
UNKNOWN
Last Update Posted:
2023-06-22
First Post:
2023-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective, Split-face, Randomized Study of the Poly-D, L Lactic Acid (PDLLA) for Photoaged Skin
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'parallel assignment split lesion study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-10', 'studyFirstSubmitDate': '2023-06-10', 'studyFirstSubmitQcDate': '2023-06-10', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of lightness value', 'timeFrame': 'Chromometer will be taken before treatment and 4,8,12 weeks after last treatment.', 'description': 'change of lightness value by a chromometer'}], 'secondaryOutcomes': [{'measure': 'patinent global assessment for skin condition', 'timeFrame': 'Questionnaire will be taken before treatment and 4,8,12 weeks after last treatment.', 'description': 'patinent global assessment for skin condition by a self-questionnaire'}, {'measure': 'investigator global assessment score for pigmentation', 'timeFrame': 'Photos will be taken before each treatment and 4,8,12 weeks after the final treatment.', 'description': 'investigator global assessment score for pigmentation by clinical photos'}, {'measure': 'Fitzpatrick wrinkle and elastosis scale', 'timeFrame': 'Photos will be taken before each treatment and 4,8,12 weeks after the final treatment', 'description': 'Fitzpatrick wrinkle and elastosis scale by clinical photos'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pigmentation', 'Pigmentation Disorder']}, 'descriptionModule': {'briefSummary': 'Juvelook® (VAIM, Korea) is made by dissolving irregular PDLLA particles in a solvent mixture of DMSO (Dimethylsulfoxide) and EC (Ethylene Carbonate) and then injecting them through microneedling to create reticulated foamy microspheres, which are hollow spherical particles. It received CE approval in Europe in 2020 and is widely used domestically as a material for tissue restoration, including skin fillers and collagen stimulators. The spherical shape with internal foam structure of PDLLA exhibits excellent biocompatibility, biodegradability, porosity, and mechanical strength. It allows for the control of particle size and acts as a collagen stimulator while gradually dissolving over time. This stimulates fibroblast cells and promotes skin rejuvenation. In clinical practice, Juvelook® particles are injected to address various concerns such as facial wrinkles, increased elasticity, depressed scars, acne scars, accident scars, under-eye hollows, freckles, whitening effects, and neck wrinkles. Therefore, this study aims to investigate the efficacy of Juvelook® not only in volume augmentation but also in improving photoaged skin.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adult women over 30 years old with photoaged skin.\n2. Individuals who have a clear understanding of the purpose and content of the study, as well as the potential risks and side effects, and voluntarily sign the informed consent form to participate in the clinical trial.\n3. Individuals who are physically healthy and can be tracked and observed throughout the entire study period.\n\nExclusion Criteria:\n\n1. Individuals who have received anti-aging/whitening treatments (such as laser or chemical peels) on their face within 3 months prior to the start of the study.\n2. Individuals who have applied anti-aging/whitening agents to their face within 3 months prior to the start of the study.\n3. Pregnant or breastfeeding women.\n4. Individuals who are participating in other clinical trials.\n5. Individuals who, in the judgment of the researchers, are deemed ineligible to participate in the study.'}, 'identificationModule': {'nctId': 'NCT05913102', 'briefTitle': 'A Prospective, Split-face, Randomized Study of the Poly-D, L Lactic Acid (PDLLA) for Photoaged Skin', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'A Prospective, Split-face, Randomized Study of the Poly-D, L Lactic Acid (PDLLA) for Photoaged Skin', 'orgStudyIdInfo': {'id': 'AJOUIRB-INT-2021-630'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'administer PDLLA', 'interventionNames': ['Drug: PDLLA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'active comparator', 'description': 'administer saline', 'interventionNames': ['Drug: PDLLA']}], 'interventions': [{'name': 'PDLLA', 'type': 'DRUG', 'description': 'Administer PDLLA/saline every 2 weeks for 2.5 months', 'armGroupLabels': ['active comparator', 'experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jin Cheol Kim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, research assistant professor', 'investigatorFullName': 'Jin Cheol Kim', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}