Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-31 @ 2:55 PM
Study NCT ID:
NCT06080035
Status:
COMPLETED
Last Update Posted:
2024-08-28
First Post:
2023-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Cetyl Tranexamate Mesylate on the Appearance of Acne-Related Hyperpigmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2023-10-02', 'studyFirstSubmitQcDate': '2023-10-06', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Facial skin pigment intensity of 3 pre-identified lesions', 'timeFrame': '2 weeks', 'description': 'Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions'}], 'secondaryOutcomes': [{'measure': 'Facial skin pigment intensity of 3 pre-identified lesions', 'timeFrame': '1 week', 'description': 'Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions'}, {'measure': 'Self-perception of skin pigmentation', 'timeFrame': '1 week', 'description': 'Survey-based self-assessment of facial skin pigmentation'}, {'measure': 'Self-perception of skin pigmentation', 'timeFrame': '2 week', 'description': 'Survey-based self-assessment of facial skin pigmentation'}, {'measure': 'Self-perception of skin redness', 'timeFrame': '1 week', 'description': 'Survey-based self-assessment of aspects of skin redness'}, {'measure': 'Self-perception of skin redness', 'timeFrame': '2 week', 'description': 'Survey-based self-assessment of aspects of skin redness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperpigmentation', 'Post-inflammatory Hyperpigmentation', 'Acne']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of Cetyl Tranexamate Mesylate on acne-related hyperpigmentation through a specific delivery form known as TeraCeutic TXVector.', 'detailedDescription': 'Hyperpigmentation is characterized as an increase in pigment on the skin and is a common skin condition in individuals with skin types III to VI on the Fitzpatrick skin classification scale. Hyperpigmentation can be localized to an area in the form of post-inflammatory hyperpigmentation or diffused in the form of melasma. One of the treatments that are used to treat hyperpigmentation is tranexamic acid (TXA) which is a third-generation bioactive and is formally known to work as a plasmin inhibitor. Since TXA is hydrophilic in nature and has a strong hydrogen-bonding capacity, it has an insufficient skin permeability. Similar to TXA esters, Cetyl Tranexamate Mesylate (CTM) is hypothesized to have greater permeability and this study will evaluate the effects of CTM on the appearance of post-inflammatory hyperpigmentation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females between the ages of 14 years of age until 55 years of age\n* Individuals experiencing 3 different areas minimum of facial post-inflammatory hyperpigmentation in those with acne\n\nExclusion Criteria:\n\n* Individuals who are pregnant or breastfeeding.\n* Prisoners.\n* Adults unable to consent.\n* Those who are unwilling to discontinue hydroquinone, vitamin A/C/E, azelaic acid, kojic acid, bakuchiol, licorice root, retinol, niacinamide, alpha arbutin, and oral or topical tranexamic acid for two weeks to meet the washout criteria prior to enrolling and for the duration of the study.\n* Subjects with any of the following facial cosmetic treatments within the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during study including microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, or any other medical treatment administered by a physician or skin care professional which is designed to improve skin pigmentation.\n* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.\n* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.'}, 'identificationModule': {'nctId': 'NCT06080035', 'briefTitle': 'The Effects of Cetyl Tranexamate Mesylate on the Appearance of Acne-Related Hyperpigmentation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integrative Skin Science and Research'}, 'officialTitle': 'Open-label, Prospective Study on the Effects of Cetyl Tranexamate Mesylate on the Appearance of Acne-Related Hyperpigmentation', 'orgStudyIdInfo': {'id': 'i23-01_CTM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical Cetyl Tranexamate Mesylate', 'description': 'Product will be used on the face twice daily in the morning and in the evening for 2 weeks.', 'interventionNames': ['Other: Topical Cetyl Tranexamate Mesylate']}], 'interventions': [{'name': 'Topical Cetyl Tranexamate Mesylate', 'type': 'OTHER', 'description': 'Topical product will be applied onto clean skin morning and night.', 'armGroupLabels': ['Topical Cetyl Tranexamate Mesylate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Integrative Skin and Research', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Raja Sivamani, MD MS AP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Integrative Skin Science and Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integrative Skin Science and Research', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Actera', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}