Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-30 @ 4:24 AM
Study NCT ID:
NCT01162850
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
2010-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Polypodium Leucotomos for Melasma
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-04', 'studyFirstSubmitDate': '2010-07-14', 'studyFirstSubmitQcDate': '2010-07-14', 'lastUpdatePostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Melasma Area and Severity Index (MASI)', 'timeFrame': 'Day 0, Week 4, Week 8, Week 12', 'description': 'The following equation is used to determine the MASI score: MASI = .3A(D+H) \\[forhead\\] + .3A(D+H)\\[right malar\\] + .3A(D+H)\\[left malar\\] + .1A(D+H)\\[chin\\]; A = area, D = darkness, and H = homogeneity. Area is based on percentage of the region covered by melasma using a 1-6 scale. Darkness is determined on a 0-3 scale. Homogeneity is based on a 0-4 scale.'}], 'secondaryOutcomes': [{'measure': 'Patient Assessment', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': 'Subject critiqued their melasma as either getting worse, showing no improvement, mild improvement or as showing marked improvement upon using the treatment.'}, {'measure': 'Evaluation of Photographs', 'timeFrame': 'Post-Week 12', 'description': 'Photos were evaluated using the grading of worse, no improvement, mild improvement or marked improvement comparing week 12 to baseline.'}, {'measure': 'Adverse Events', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': 'Recorded any and all adverse events that occurred even if it was unlikely that it was associated with the study product.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Melasma'], 'conditions': ['Melasma']}, 'descriptionModule': {'briefSummary': 'Primary Objective: To determine whether there is improvement in the melasma of participants taking oral Polypodium Leucotomos Secondary Objective: To determine whether oral Polypodium Leucotomos is well tolerated in study subjects with melasma.\n\nTo determine whether treatment with Polypodium Leucotomos improves the health-related quality of life.', 'detailedDescription': 'Polypodium Leucotomos is a fern, also known as Calaguala used by the natives of northern Honduras as a treatment against malignant tumors Used in Spain and Central America for the treatment of psoriasis, atopic dermatitis and repigmentation of vitiligo.\n\nOral Polypodium Leucotomos is safe and effective in patients with melasma.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy female subjects 18-50 years of age.\n* Female subjects with epidermal melasma.\n* Female subjects of child-bearing potential must have been willing to use an acceptable form of birth control for the duration of the study.\n* Subjects with Fitzpatrick skin types II, III, \\& IV\n* Subjects enrolled in this trial had a 2 week washout period if on prior treatment for melasma.\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Dermal Melasma\n* Hormonal therapies less than or equal too 4 weeks prior to study\n* Use of photosensitizing medications\n* Simultaneous use of any form of treatment for melasma\n* Subjects who were concurrently receiving light therapies\n* Subjects who were unwilling to limit the amount of sun exposure\n* Simultaneous ( or past 30 day) participation in a clinical research study.'}, 'identificationModule': {'nctId': 'NCT01162850', 'briefTitle': 'Oral Polypodium Leucotomos for Melasma', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'A Randomized Double-Blind Placebo Controlled Study Evaluating the Effectiveness and Tolerability of Oral Polypodium Leucotomos in Patients With Melasma', 'orgStudyIdInfo': {'id': '20070050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Polypodium Leucotomos', 'description': 'Oral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks.', 'interventionNames': ['Dietary Supplement: Polypodium Leucotomos']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral Placebo twice daily plus sunscreen SPF 45 for 12 weeks.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Polypodium Leucotomos', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral capsule at 240 mg taken twice a day for 12 weeks', 'armGroupLabels': ['Polypodium Leucotomos']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '240 mg Placebo taken orally twice daily created by company which manufactured active ingredient', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33140', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Cosmetic Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Heather Woolery-Lloyd, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Heather Woolery-Lloyd, MD', 'oldOrganization': 'University of Miami'}}}}