Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-26 @ 10:37 PM
Study NCT ID:
NCT04140292
Status:
COMPLETED
Last Update Posted:
2022-06-24
First Post:
2019-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitamin D Supplementation as a Neoadjuvant for Photodynamic Therapy of Actinic Keratoses
Sponsor:
Organization:
Raw JSON
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They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.\n\nPhotodynamic therapy (PDT): PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells\n\nNoninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.\n\nVitamin D3: D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment\n\nParticipants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Photodynamic Therapy (PDT)', 'description': 'Data for the participants in this arm are from a previous basic science study that looked at Vit D level that got standard of care PDT. These participants were used as a control group.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical PDT Response as Measured by Percent Change in AK Lesions From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 + Photodynamic Therapy (PDT)', 'description': 'Patients receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.\n\nPhotodynamic therapy (PDT): PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells\n\nNoninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.\n\nVitamin D3: D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment\n\nParticipants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result'}, {'id': 'OG001', 'title': 'Photodynamic Therapy (PDT)', 'description': 'Participants will be matched to other participants from a prior study (NCT03467789) involving PDT only, based on their baseline vitamin D level. These participants were used as a control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '72.5', 'spread': '13.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after treatment', 'description': 'Clinical PDT response as measured by the percent change of AK lesions 3 months after treatment\n\nBaseline vitamin D (calcidiol) level will be taken for each patient.', 'unitOfMeasure': 'Percent change of AK lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received treatment.'}, {'type': 'SECONDARY', 'title': 'Correlation Between Vitamin D Receptor (VDR) Polymorphisms and Percent Reduction in AK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 + Photodynamic Therapy (PDT)', 'description': 'Patients receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.\n\nPhotodynamic therapy (PDT): PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells\n\nNoninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.\n\nVitamin D3: D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment\n\nParticipants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result'}, {'id': 'OG001', 'title': 'Photodynamic Therapy (PDT)', 'description': 'Participants will be matched to other participants from a prior study (NCT03467789) involving PDT only, based on their baseline vitamin D level. These participants were used as a control group.'}], 'timeFrame': '3 months after treatment', 'description': 'Whether gene polymorphisms in VDR and CYP27B1 are predictive for the degree of responsiveness (as measured by percent reduction in AK) to Vitamin D as a neoadjuvant for PDT.', 'reportingStatus': 'POSTED', 'populationDescription': 'Unable to obtain any information about the PpIX accumulation levels because fluorescence imaging dosimeter broke down and it was unable to be replaced.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting 1 or Higher on the Pain Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 + Photodynamic Therapy (PDT)', 'description': 'Participants receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.\n\nPhotodynamic therapy (PDT): PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells\n\nNoninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.\n\nVitamin D3: D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment\n\nParticipants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result'}, {'id': 'OG001', 'title': 'Photodynamic Therapy (PDT)', 'description': 'Participants will be matched to other participants from a prior study (NCT03467789) involving PDT only, based on their baseline vitamin D level. These participants were used as a control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During treatment (at the 5 min mark), and again immediately afterwards.', 'description': 'Pain scale recorded on a 0-to-10 visual/analog scale, with higher scores mean more pain; 0 is no pain, 10 is "the worst pain imaginable". Number of participants receiving treatment that reported a pain level greater than 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that received treatment.'}, {'type': 'SECONDARY', 'title': "Tolerability as Measured by Participants' Symptom Score Sheets", 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 + Photodynamic Therapy (PDT)', 'description': 'Patients receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.\n\nPhotodynamic therapy (PDT): PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells\n\nNoninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.\n\nVitamin D3: D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment\n\nParticipants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result'}, {'id': 'OG001', 'title': 'Photodynamic Therapy (PDT)', 'description': 'Participants will be matched to other participants from a prior study (NCT03467789) involving PDT only, based on their baseline vitamin D level. These participants were used as a control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week after treatment', 'description': 'Participants are asked to recall the symptoms they experienced during the week following PDT. The study physician asks them whether they had experienced each of the following 13 symptoms (YES/NO), and positive (YES) answers were summed to create a Side Effects Score (SES). The maximum and minimum possible values are 13 and 0 respectively, with a higher score correlating to poorer participant outcomes.\n\nThe 13 possible side effects were: pain, erythema, scabbing, blistering, erosions, edema, warmth, exfoliation, discharge, hemorrhage, tightness, hyperpigmentation, hypopigmentation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received treatment.'}, {'type': 'SECONDARY', 'title': 'Accumulation of Protoporphyrin IX (PpIX) Within AK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 + Photodynamic Therapy (PDT)', 'description': 'Patients receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.\n\nPhotodynamic therapy (PDT): PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells\n\nNoninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.\n\nVitamin D3: D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment\n\nParticipants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result'}, {'id': 'OG001', 'title': 'Photodynamic Therapy (PDT)', 'description': 'Participants will be matched to other participants from a prior study (NCT03467789) involving PDT only, based on their baseline vitamin D level. These participants were used as a control group.'}], 'timeFrame': '3 months after treatment', 'description': 'Accumulation of protoporphyrin IX (PpIX) within AK\n\nPpIX accumulation in areas of both actinic damage and normal skin will be measured with a fluorescence dosimeter. The level of calcidiol, a clinically accepted marker of vitamin D status, will be measured in each patient to see if supplementation with 10,000 IU of Vitamin D increase the accumulation', 'reportingStatus': 'POSTED', 'populationDescription': 'Unable to obtain any information about the PpIX accumulation levels because fluorescence imaging dosimeter broke down and it was unable to be replaced.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vitamin D3 + Photodynamic Therapy (PDT)', 'description': 'Patients receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.\n\nPhotodynamic therapy (PDT): PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells\n\nNoninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.\n\nVitamin D3: D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment\n\nParticipants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result'}, {'id': 'FG001', 'title': 'Photodynamic Therapy (PDT)', 'description': 'Participants will be matched to other participants from a prior study (NCT03467789) involving PDT only, based on their baseline vitamin D level. These participants were used as a control group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Restriction on outpatient visits due to COVID-19.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vitamin D3 + Photodynamic Therapy (PDT)', 'description': 'Patients receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.\n\nPhotodynamic therapy (PDT): PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells\n\nNoninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.\n\nVitamin D3: D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment\n\nParticipants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result'}, {'id': 'BG001', 'title': 'Photodynamic Therapy (PDT)', 'description': 'Data for the participants in this arm are from a previous basic science study that looked at Vit D level that got standard of care PDT. These participants were used as a control group.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who completed the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-13', 'size': 1569029, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-01T15:10', 'hasProtocol': True}, {'date': '2022-04-13', 'size': 393952, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-06-01T15:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Study group will be compared to a baseline cohort of patients from a previous study (IRB 16-1615) who received the same regimen of PDT, but without any Vit D'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-01', 'studyFirstSubmitDate': '2019-10-24', 'resultsFirstSubmitDate': '2022-03-16', 'studyFirstSubmitQcDate': '2019-10-24', 'lastUpdatePostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-01', 'studyFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical PDT Response as Measured by Percent Change in AK Lesions From Baseline to 3 Months', 'timeFrame': '3 months after treatment', 'description': 'Clinical PDT response as measured by the percent change of AK lesions 3 months after treatment\n\nBaseline vitamin D (calcidiol) level will be taken for each patient.'}], 'secondaryOutcomes': [{'measure': 'Correlation Between Vitamin D Receptor (VDR) Polymorphisms and Percent Reduction in AK', 'timeFrame': '3 months after treatment', 'description': 'Whether gene polymorphisms in VDR and CYP27B1 are predictive for the degree of responsiveness (as measured by percent reduction in AK) to Vitamin D as a neoadjuvant for PDT.'}, {'measure': 'Number of Participants Reporting 1 or Higher on the Pain Scale', 'timeFrame': 'During treatment (at the 5 min mark), and again immediately afterwards.', 'description': 'Pain scale recorded on a 0-to-10 visual/analog scale, with higher scores mean more pain; 0 is no pain, 10 is "the worst pain imaginable". Number of participants receiving treatment that reported a pain level greater than 1.'}, {'measure': "Tolerability as Measured by Participants' Symptom Score Sheets", 'timeFrame': '1 week after treatment', 'description': 'Participants are asked to recall the symptoms they experienced during the week following PDT. The study physician asks them whether they had experienced each of the following 13 symptoms (YES/NO), and positive (YES) answers were summed to create a Side Effects Score (SES). The maximum and minimum possible values are 13 and 0 respectively, with a higher score correlating to poorer participant outcomes.\n\nThe 13 possible side effects were: pain, erythema, scabbing, blistering, erosions, edema, warmth, exfoliation, discharge, hemorrhage, tightness, hyperpigmentation, hypopigmentation.'}, {'measure': 'Accumulation of Protoporphyrin IX (PpIX) Within AK', 'timeFrame': '3 months after treatment', 'description': 'Accumulation of protoporphyrin IX (PpIX) within AK\n\nPpIX accumulation in areas of both actinic damage and normal skin will be measured with a fluorescence dosimeter. The level of calcidiol, a clinically accepted marker of vitamin D status, will be measured in each patient to see if supplementation with 10,000 IU of Vitamin D increase the accumulation'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Actinic Keratosis']}, 'referencesModule': {'references': [{'pmid': '35314199', 'type': 'DERIVED', 'citation': 'Bullock TA, Negrey J, Hu B, Warren CB, Hasan T, Maytin EV. Significant improvement of facial actinic keratoses after blue light photodynamic therapy with oral vitamin D pretreatment: An interventional cohort-controlled trial. J Am Acad Dermatol. 2022 Jul;87(1):80-86. doi: 10.1016/j.jaad.2022.02.067. Epub 2022 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'This study is open to individuals with Actinic Keratoses (skin lesions that have the potential to turn into skin cancer), who are receiving photodynamic therapy (PDT) as part of their clinical care. The purpose of this study is to test and demonstrate that vitamin D pre-treatment can enhance PDT efficacy in the treatment of Actinic Keratoses.\n\nParticipants will be asked to take vitamin D supplements prior to their standard of care PDT treatment.\n\nParticipation in the research will last about 3-4 months.', 'detailedDescription': 'The primary objective of this study is to determine whether acute supplementation (neoadjuvant Vitamin D3), adjusted according to baseline Vitamin D status, can improve the clinical PDT response relative to participants receiving PDT alone\n\nThe secondary objective of this study is to determine whether gene polymorphisms in VDR and CYP27B1 are predictive for the degree of responsiveness to Vitamin D as a neoadjuvant for PDT.\n\nThis study is a non-randomized interventional trial, in which the study group will be compared to a baseline cohort of patients from a previous study who received the same regimen of PDT, but without any Vit D. It is anticipated that 30 participants will be involved in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Actinic keratoses in sufficient numbers (\\>10) to warrant PDT therapy in the clinic\n* Able to understand and willing to sign a written informed consent document\n* Female subjects must not become pregnant during the study:\n\n * The effects of 5-aminolevulinic acid (LevulanTM) on the human fetus are unknown. For this reason, women of child-bearing potential must agree to use contraception (double barrier method of birth control or abstinence) prior to study entry, and throughout study participation. Should a woman become pregnant or suspect that she is pregnant while she is participating in this study, she should inform the treating physician immediately.\n\nExclusion Criteria:\n\n* Pregnant or nursing.\n* At risk for hypercalcemia (renal disease, sarcoidosis, etc.)\n* Using topical retinoids, since these can exacerbate the post-PDT erythema reaction.\n* Using any topical treatment on their AKs; must stop at least one month prior.\n* Currently undergoing treatment for other cancers with medical or radiation therapy.\n* Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material.\n* Patients with history of a photosensitivity disease, such as porphyria cutanea tarda.\n* Currently participating in another clinical trial.'}, 'identificationModule': {'nctId': 'NCT04140292', 'briefTitle': 'Vitamin D Supplementation as a Neoadjuvant for Photodynamic Therapy of Actinic Keratoses', 'nctIdAliases': ['NCT04482322'], 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Vitamin D Supplementation as a Neoadjuvant for Photodynamic Therapy of Actinic Keratoses', 'orgStudyIdInfo': {'id': 'CASE5619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D3 + Photodynamic therapy (PDT)', 'description': 'Patients receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.', 'interventionNames': ['Drug: Photodynamic therapy (PDT)', 'Drug: Vitamin D3']}], 'interventions': [{'name': 'Photodynamic therapy (PDT)', 'type': 'DRUG', 'description': 'PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells\n\nNoninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.', 'armGroupLabels': ['Vitamin D3 + Photodynamic therapy (PDT)']}, {'name': 'Vitamin D3', 'type': 'DRUG', 'description': 'D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment\n\nParticipants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result', 'armGroupLabels': ['Vitamin D3 + Photodynamic therapy (PDT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Edward V Maytin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'All IPD that underlie results in publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}