Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT05380635
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
2022-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009182', 'term': 'Mycosis Fungoides'}], 'ancestors': [{'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C004965', 'term': 'hypericin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rstraube@soligenix.com', 'phone': '609-538-8200', 'title': 'Richard Straube, MD/Chief Medical Officer', 'organization': 'Soligenix, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '10 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'HyBryte (0.25 % Hypericin)', 'description': 'HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 5 J/cm\\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 8 weeks.\n\nHypericin: HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Coronavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Electrocardiograms (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HyBryte (0.25 % Hypericin)', 'description': 'HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 5 J/cm\\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 8 weeks.\n\nHypericin: HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 weeks', 'description': 'Assess any ECG QT interval changes (defined as any occurrences of QT interval \\>500 ms or changes in QT interval \\>60 ms) during standard HyBryte photodynamic therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Systemic Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HyBryte (0.25 % Hypericin)', 'description': 'HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 5 J/cm\\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 8 weeks.\n\nHypericin: HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00013', 'spread': '0.00011', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': 'Assess the systemic blood levels of hypericin during standard HyBryte photodynamic therapy.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HyBryte (0.25 % Hypericin)', 'description': 'HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 5 J/cm\\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 8 weeks.\n\nHypericin: HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Non-Responder', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 weeks', 'description': 'A treatment response was defined as a ≥50% improvement in CAILS score at Week 10 when compared to the CAILS score at baseline.\n\nThe Composite Assessment of Index Lesion Disease Severity (CAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\\^2) to 18 (the lesion is larger than 300 cm\\^2). A lower score means a better outcome.\n\nThe overall CAILS score was calculated by adding the total score as described above for each of the 3 lesions. The overall CAILS score has a range of 0 to 111. A lower score means a better outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Index Lesions With a Treatment Response as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}, {'units': 'Index Lesions', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HyBryte (0.25 % Hypericin)', 'description': 'HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 5 J/cm\\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 8 weeks.\n\nHypericin: HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Non-Responder', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '10 weeks', 'description': 'A treatment response was defined as a ≥50% improvement in CAILS score at Week 10 when compared to the CAILS score at baseline in each of the individual Index Lesions.\n\nThe Composite Assessment of Index Lesion Disease Severity (CAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\\^2) to 18 (the lesion is larger than 300 cm\\^2). A lower score means a better outcome.', 'unitOfMeasure': 'Index Lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Index Lesions', 'denomUnitsSelected': 'Index Lesions', 'populationDescription': 'Each participant had 3 Index Lesions treated and evaluated'}, {'type': 'SECONDARY', 'title': 'Number of Index Lesions With a Complete Response as Defined as a 100% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}, {'units': 'Index Lesions', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HyBryte (0.25 % Hypericin)', 'description': 'HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 5 J/cm\\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 8 weeks.\n\nHypericin: HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Non-Responder', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '10 weeks', 'description': 'A complete response was defined as a 100% improvement in CAILS score (a CAILS score of 0) at Week 10 in each of the individual Index Lesions.\n\nThe Composite Assessment of Index Lesion Disease Severity (CAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\\^2) to 18 (the lesion is larger than 300 cm\\^2). A lower score means a better outcome.', 'unitOfMeasure': 'Index Lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Index Lesions', 'denomUnitsSelected': 'Index Lesions', 'populationDescription': 'Each participant had 3 Index Lesions treated and evaluated'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HyBryte (0.25 % Hypericin)', 'description': 'HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 5 J/cm\\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 8 weeks.\n\nHypericin: HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HyBryte (0.25 % Hypericin)', 'description': 'HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 5 J/cm\\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 8 weeks.\n\nHypericin: HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'spread': '7.79', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-22', 'size': 2204190, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-11T10:26', 'hasProtocol': True}, {'date': '2022-07-29', 'size': 348137, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-11T10:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2022-05-09', 'resultsFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2022-05-13', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-11', 'studyFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electrocardiograms (ECG)', 'timeFrame': '10 weeks', 'description': 'Assess any ECG QT interval changes (defined as any occurrences of QT interval \\>500 ms or changes in QT interval \\>60 ms) during standard HyBryte photodynamic therapy.'}, {'measure': 'Systemic Blood Levels', 'timeFrame': '10 weeks', 'description': 'Assess the systemic blood levels of hypericin during standard HyBryte photodynamic therapy.'}], 'secondaryOutcomes': [{'measure': 'Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.', 'timeFrame': '10 weeks', 'description': 'A treatment response was defined as a ≥50% improvement in CAILS score at Week 10 when compared to the CAILS score at baseline.\n\nThe Composite Assessment of Index Lesion Disease Severity (CAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\\^2) to 18 (the lesion is larger than 300 cm\\^2). A lower score means a better outcome.\n\nThe overall CAILS score was calculated by adding the total score as described above for each of the 3 lesions. The overall CAILS score has a range of 0 to 111. A lower score means a better outcome.'}, {'measure': 'Number of Index Lesions With a Treatment Response as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.', 'timeFrame': '10 weeks', 'description': 'A treatment response was defined as a ≥50% improvement in CAILS score at Week 10 when compared to the CAILS score at baseline in each of the individual Index Lesions.\n\nThe Composite Assessment of Index Lesion Disease Severity (CAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\\^2) to 18 (the lesion is larger than 300 cm\\^2). A lower score means a better outcome.'}, {'measure': 'Number of Index Lesions With a Complete Response as Defined as a 100% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.', 'timeFrame': '10 weeks', 'description': 'A complete response was defined as a 100% improvement in CAILS score (a CAILS score of 0) at Week 10 in each of the individual Index Lesions.\n\nThe Composite Assessment of Index Lesion Disease Severity (CAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\\^2) to 18 (the lesion is larger than 300 cm\\^2). A lower score means a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CTCL', 'MF', 'Hypericin', 'HyBryte'], 'conditions': ['Cutaneous T-Cell Lymphoma/Mycosis Fungoides']}, 'descriptionModule': {'briefSummary': 'To assess the blood levels of hypericin and any electrocardiogram (ECG) changes during 8 weeks of HyBryte (topical hypericin ointment) photodynamic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IB or Stage IIA\n* CTCL lesions covering ≥ 10% of their body surface area\n\nExclusion Criteria:\n\n* History of allergy or hypersensitivity to any of the components of HyBryte\n* Pregnancy or mothers who are breast-feeding\n* Males and females not willing to use effective contraception\n* Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g., porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.)\n* Subjects whose condition is spontaneously improving\n* Subjects receiving topical steroids or other topical treatments (e.g., nitrogen mustard) on index lesions for CTCL within 2 weeks of enrollment\n* Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy (PUVA), narrow band ultraviolet B (UVB) light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment\n* Subjects who have received electron beam irradiation within 3 months of enrollment\n* Subjects with a history of significant systemic immunosuppression\n* Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment\n* Subjects receiving drugs known to cause photosensitization within 2 weeks of starting HyBryte therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks"}, 'identificationModule': {'nctId': 'NCT05380635', 'briefTitle': 'PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Soligenix'}, 'officialTitle': 'Phase 2a Study of Systemic PK and Serial ECG Determinations Following 8 Weeks of HyBryte Treatment', 'orgStudyIdInfo': {'id': 'HPN-CTCL-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HyBryte (0.25 % Hypericin)', 'description': 'HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 5 J/cm\\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 8 weeks.', 'interventionNames': ['Drug: Hypericin']}], 'interventions': [{'name': 'Hypericin', 'type': 'DRUG', 'otherNames': ['HyBryte', 'SGX301'], 'description': 'HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.', 'armGroupLabels': ['HyBryte (0.25 % Hypericin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14450', 'city': 'Fairport', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Skin Lymphoma Medical Group', 'geoPoint': {'lat': 43.09867, 'lon': -77.44194}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soligenix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}