Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-11 @ 12:56 AM
Study NCT ID:
NCT06957834
Status:
COMPLETED
Last Update Posted:
2025-05-05
First Post:
2025-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Eflornithine Hydrochloride Cream in the Treatment of Melasma: A Randomized, Double-blinded, Split-face Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008548', 'term': 'Melanosis'}], 'ancestors': [{'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a randomized, double-blinded, split-face study. Both treatments (Eflornithine hydrochloride, and Hydroquinone) will be applied simultaneously: one on the left side of the face and the other on the right side. Treatment allocation to facial sides will be randomized, and participants blinded (both treatments with similar packaging, look and consistency). Outcomes will be assessed on each side of the face by a blinded evaluator.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2025-05-02', 'studyFirstSubmitQcDate': '2025-05-02', 'lastUpdatePostDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Melasma Area and Severity Index (mMASI)', 'timeFrame': 'At 8 weeks and 12 weeks'}, {'measure': 'Mexameter melanin score', 'timeFrame': 'At 8 and 12 weeks', 'description': 'Mexameter device (Courage + Khazaka Electronic GmbH, Germany)'}], 'secondaryOutcomes': [{'measure': 'Mexameter erythema score', 'timeFrame': 'At 8 and 12 weeks', 'description': 'Mexameter device (Courage + Khazaka Electronic GmbH, Germany)'}, {'measure': 'Patient Satisfaction Score', 'timeFrame': 'At 8 and 12 weeks', 'description': 'For each side of the face, each patient and dermatologist was asked to grade the severity of melasma from a score of 0 (cleared), 1 (mild), 2 (moderate) to 3 (severe)'}, {'measure': 'Physician Global Assessment', 'timeFrame': 'At 8 and 12 weeks', 'description': 'For each side of the face, each patient and dermatologist was asked to grade the severity of melasma from a score of 0 (cleared), 1 (mild), 2 (moderate) to 3 (severe)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melasma', 'Dermatology', 'Eflornithine'], 'conditions': ['Melasma']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if Eflornithine hydrochloride cream works to treat melasma in adults, in comparison to Hydroquinone cream. It will also learn about the safety of Eflornithine hydrochloride cream. The main questions it aims to answer are:\n\n* Does Eflornithine hydrochloride improve melasma assessment scores over a 3-month duration compared to Hydroquinone cream?\n* What side effects might patients get while using Eflornithine hydrochloride cream?\n\nParticipants will:\n\n* Apply both Eflornithine hydrochloride and Hydroquinone creams on separate halves of their faces every day for 3 months.\n* Visit the clinic once at the 2-month mark and once at the 3-month mark for checkups and tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of melasma\n* Fitzpatrick Type III or IV\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Pregnant or lactating patients\n* Patients with difficulty adhering to regular topical treatments\n* Patients with known contact allergies to any of the ingredients in the topical medications used in the study'}, 'identificationModule': {'nctId': 'NCT06957834', 'briefTitle': 'Efficacy of Eflornithine Hydrochloride Cream in the Treatment of Melasma: A Randomized, Double-blinded, Split-face Controlled Study', 'organization': {'class': 'NETWORK', 'fullName': 'National Skin Centre'}, 'officialTitle': 'Randomised Double-blinded Split-face Controlled Study to Evaluate the Effectiveness of Eflornithine Hydrochloride Cream Compared to Topical Hydroquinone 2% Cream for the Treatment of Melasma.', 'orgStudyIdInfo': {'id': '2019/00399'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face', 'interventionNames': ['Drug: Eflornithine hydrochloride cream', 'Drug: Hydroquinone cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face', 'interventionNames': ['Drug: Eflornithine hydrochloride cream', 'Drug: Hydroquinone cream']}], 'interventions': [{'name': 'Eflornithine hydrochloride cream', 'type': 'DRUG', 'description': 'Eflornithine hydrochloride cream at 11.5% applied twice daily', 'armGroupLabels': ['Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face', 'Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face']}, {'name': 'Hydroquinone cream', 'type': 'DRUG', 'description': 'Hydroquinone 2% cream, applied twice daily', 'armGroupLabels': ['Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face', 'Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Skin Centre', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'ipdSharingStatementModule': {'timeFrame': 'Beginning 6 months and ending 2 years after publication', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in publication', 'accessCriteria': 'Upon reasonable request to corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Skin Centre', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director and Senior Consultant', 'investigatorFullName': 'Steven Thng Tien Guan', 'investigatorAffiliation': 'National Skin Centre'}}}}