Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-02-22 @ 3:55 PM
Study NCT ID:
NCT02409732
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2015-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535669', 'term': 'Actinic cheilitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000622', 'term': 'Aminolevulinic Acid'}, {'id': 'D010778', 'term': 'Photochemotherapy'}, {'id': 'D000095743', 'term': 'Blue Light'}, {'id': 'C008848', 'term': '1-phenyl-3,3-dimethyltriazene'}], 'ancestors': [{'id': 'D007982', 'term': 'Levulinic Acids'}, {'id': 'D007651', 'term': 'Keto Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D008027', 'term': 'Light'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Michael.Shane.Chapman@hitchcock.org', 'phone': '603-650-3106', 'title': 'Dr. Michael Shane Chapman Section Chief of Dermatology', 'organization': 'Dartmouth-Hitchcock Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Visits 2 (Baseline), Visits 3 (week 6), and Visit 4 (week 12), Visit 5 (week 24), Visit 6 (week 36)', 'eventGroups': [{'id': 'EG000', 'title': 'Photodynamic Therapy With Blue Light', 'description': 'Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'URI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling of right hand', 'notes': 'Patient underwent mohs surgery on the right hand. This adverse event was not related to the study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Red spots', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bleeding esophageal ulcer', 'notes': 'Bleeding esophageal ulcer requiring inpatient hospitalization during the study treatment. This was deemed unrelated to the study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Change in Clearance From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Therapy With Blue Light', 'description': 'Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.'}], 'classes': [{'title': '0% improvement at V6 (week 36)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '50% improvement at V6 (week 36)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '75% improvement at V6 (week 36)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': '100% % improvement at V6 (week 36)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Discontinued/Withdrew/Lost to follow up', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2 (Baseline) to Visit 5 or 6 (Week 24 or 36)', 'description': 'Clearance will be estimated clinically as minimal (0%-25%), mild (26%-50%), moderate (51%-75%), good (76%-99%), or complete (100%). Results will also be evaluated by comparing photographs before and immediately after treatments, and 12 and 24 weeks after the last treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Twenty patients were enrolled into the study. Please see baseline characteristics to understand the patient demographic.'}, {'type': 'SECONDARY', 'title': 'Average Change in Participant Reported Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Treatment visits', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Therapy With Blue Light', 'description': 'Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.'}], 'classes': [{'title': 'Avg change of pain prior to tx to during tx', 'categories': [{'measurements': [{'value': '2.86', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '4'}]}]}, {'title': 'Avg change of pain during tx to after tx', 'categories': [{'measurements': [{'value': '-0.76', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 36', 'description': 'Subject reported pain before, during and after blue light illumination was documented using a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst pain imaginable). The maximum change in pain is 10 for each occurrence (pain before compared to during treatment and pain during compared to after treatment). This is multiplied by the number of subjects and then divided by the number of treatments to generate the range. The summation of the change between subject reported pain prior to compared to during blue light treatment was divided by the total number of treatments to obtain the average value. The summation of the change between subject reported pain during compared to after blue light treatment was divided by the total number of treatments to obtain the average value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treatment visits', 'denomUnitsSelected': 'Treatment visits', 'populationDescription': 'Twenty participants completed 50 treatments and the change in local skin reaction (pre-treatment, during treatment and post-treatment) was evaluated at each visit.\n\nNumber of Patients by Number of Treatments received:\n\nOne Treatment: 4 Two Treatments :2 Three Treatments:14'}, {'type': 'SECONDARY', 'title': 'Average Change in Local Skin Reactions to Blue Light Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Treatment visits', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Therapy With Blue Light', 'description': 'Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.'}], 'classes': [{'title': 'Swelling', 'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '3'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '3'}]}]}, {'title': 'Flaking/Scaling (Skin Dryness)', 'categories': [{'measurements': [{'value': '1.82', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 36', 'description': 'Assessments of swelling, erythema, and flaking/scaling were conducted after each treatment and two days post-treatment using a five-point ordinal scale (0: none to 4: severe). The average change in swelling, erythema and flaking/scaling after each treatment and two days post treatment were divided by the 50 total treatments to obtain the average value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treatment visits', 'denomUnitsSelected': 'Treatment visits', 'populationDescription': 'Twenty participants completed 50 treatments and the change in local skin reaction (pre-treatment, during treatment and post-treatment) was evaluated at each visit.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Who Developed a Local Skin Reaction to Blue Light Treatment: Vesiculation/Pustulation, Erosion/Ulceration, Crusting and Hyperpigmentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Treatment visits', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Therapy With Blue Light', 'description': 'Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.'}], 'classes': [{'title': 'Vesiculation/Pustulation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Erosion/Ulceration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Crusting', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Hyperpigmentation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 36', 'description': 'Assessments of vesiculation/pustulation, erosion/ulceration, and crusting were conducted immediately after each blue light treatment using a five-point ordinal scale (0: none to 4: severe). The presence or absence of hyperpigmentation in the treatment area was also documented after each treatment visit. The total number of participants who developed a local skin reaction is documented.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treatment visits', 'denomUnitsSelected': 'Treatment visits', 'populationDescription': 'Twenty participants completed 50 treatments and the change in local skin reaction (pre-treatment, during treatment and post-treatment) was evaluated at each visit.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Therapy With Blue Light', 'description': 'Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments'}], 'classes': [{'title': 'Upper respiratory infection (URI)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Lesion on mid chest', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Red spots', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Bleeding esophageal ulcer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 36', 'description': 'Evaluation of any reported local or systemic events outside the treatment area and other than those specified under local skin reactions or PDT reactions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Photodynamic Therapy With Blue Light', 'description': 'Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'First patient consented on 4/23/15', 'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Twenty four patients were screened to participate. Three men and one woman did not meet criteria to participate in the study.', 'preAssignmentDetails': 'Twenty four patients were screened to participate, but only 20 entered into the study (3 men and 1 woman screen failed). This was an open label proof of concept study and our goal was to enroll a total of 20 patients, which we achieved.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Photodynamic Therapy With Blue Light', 'description': 'Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', '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': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', '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'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Income', 'classes': [{'title': '$10,000-25,000', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '$26,000-50,000', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '$51,000-75,000', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '$76,000-100,000', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '>$100,000', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Prefer not to answer', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Twenty four patients were screened, but only 20 were included in the study and proceeded to the baseline assessment. Nine men and 11 women RECEIVED AT LEAST ONE TREATMENT.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-10-14', 'size': 558111, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-07T15:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2015-03-27', 'resultsFirstSubmitDate': '2018-06-28', 'studyFirstSubmitQcDate': '2015-04-06', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-22', 'studyFirstPostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Change in Clearance From Baseline', 'timeFrame': 'Visit 2 (Baseline) to Visit 5 or 6 (Week 24 or 36)', 'description': 'Clearance will be estimated clinically as minimal (0%-25%), mild (26%-50%), moderate (51%-75%), good (76%-99%), or complete (100%). Results will also be evaluated by comparing photographs before and immediately after treatments, and 12 and 24 weeks after the last treatment.'}], 'secondaryOutcomes': [{'measure': 'Average Change in Participant Reported Pain', 'timeFrame': 'Baseline to Week 36', 'description': 'Subject reported pain before, during and after blue light illumination was documented using a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst pain imaginable). The maximum change in pain is 10 for each occurrence (pain before compared to during treatment and pain during compared to after treatment). This is multiplied by the number of subjects and then divided by the number of treatments to generate the range. The summation of the change between subject reported pain prior to compared to during blue light treatment was divided by the total number of treatments to obtain the average value. The summation of the change between subject reported pain during compared to after blue light treatment was divided by the total number of treatments to obtain the average value.'}, {'measure': 'Average Change in Local Skin Reactions to Blue Light Treatment', 'timeFrame': 'Baseline to Week 36', 'description': 'Assessments of swelling, erythema, and flaking/scaling were conducted after each treatment and two days post-treatment using a five-point ordinal scale (0: none to 4: severe). The average change in swelling, erythema and flaking/scaling after each treatment and two days post treatment were divided by the 50 total treatments to obtain the average value.'}, {'measure': 'The Number of Participants Who Developed a Local Skin Reaction to Blue Light Treatment: Vesiculation/Pustulation, Erosion/Ulceration, Crusting and Hyperpigmentation', 'timeFrame': 'Baseline to Week 36', 'description': 'Assessments of vesiculation/pustulation, erosion/ulceration, and crusting were conducted immediately after each blue light treatment using a five-point ordinal scale (0: none to 4: severe). The presence or absence of hyperpigmentation in the treatment area was also documented after each treatment visit. The total number of participants who developed a local skin reaction is documented.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Baseline to Week 36', 'description': 'Evaluation of any reported local or systemic events outside the treatment area and other than those specified under local skin reactions or PDT reactions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Actinic cheilitis', 'Photodynamic therapy', 'Levulan', 'Blue light'], 'conditions': ['Actinic Cheilitis']}, 'referencesModule': {'references': [{'pmid': '22714758', 'type': 'BACKGROUND', 'citation': 'Ribeiro CF, Souza FH, Jordao JM, Haendchen LC, Mesquita L, Schmitt JV, Faucz LL. Photodynamic therapy in actinic cheilitis: clinical and anatomopathological evaluation of 19 patients. An Bras Dermatol. 2012 May-Jun;87(3):418-23. doi: 10.1590/s0365-05962012000300011.'}, {'pmid': '22052302', 'type': 'BACKGROUND', 'citation': 'Zaiac M, Clement A. Treatment of actinic cheilitis by photodynamic therapy with 5-aminolevulinic acid and blue light activation. J Drugs Dermatol. 2011 Nov;10(11):1240-5.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of PDT with blue light and topical Levulan in the treatment of actinic cheilitis.', 'detailedDescription': "The study will consist of a screening visit, up to three scheduled treatments, and two scheduled office visits. There can be a three-day window period for each scheduled visit in order to accommodate the subject's schedule and unforeseen scheduling conflicts.\n\n1. Visit 1 (Screening): Subjects can be screened for the study up to two weeks before Visit 2 (Baseline). During screening, the study will be reviewed, written informed consent obtained, and eligibility confirmed. If applicable, the washout from prohibited medications or treatments will be determined at this visit.\n2. Visit 2 (Baseline): Following signed, written informed consent and confirmation of eligibility, all subjects will have their lips photographed. Medical history, dermatologic exam, urine pregnancy test (if applicable), review of concomitant medications, clinical evaluations, and tolerability assessments will be performed at this visit. Study medication application to clean skin will be followed by a 90 minute incubation period under occlusion. Subsequently, patients will be exposed to blue light therapy for 16 minutes and 40 seconds. Post-therapy assessments will be performed afterwards, as well as education on appropriate sun protection methods.\n3. Visits 3-4: Subjects will return every six weeks for up to two additional treatments. Treatment will be discontinued once the patient has achieved clinical clearance. Tolerability assessments, study medication application, blue light therapy, post-therapy assessments, and photographs will be performed.\n4. Visit 5-6 (End of Study): Subjects will return 12 and 24 weeks after the last treatment for clinical evaluations, tolerability assessments, and photographs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be able to understand and voluntarily sign an informed consent form\n* Must be male or female ≥ 18 years of age at the time of consent\n* Must be able to adhere to the study visit schedule and other protocol requirements\n* Must have a diagnosis of actinic cheilitis by histopathological evaluation of biopsy specimen or clinical presentation\n\nExclusion Criteria:\n\n* Inability to provide voluntarily consent or mentally incompetent\n* Active herpes labialis lesions\n* Subjects with any condition which places the subject at unacceptable risk if he/she were to participate in the study, or confounds the ability to interpret data from the study\n* Subjects with any other skin condition that might affect the evaluation of the study disease\n* Pregnant or breastfeeding female subjects\n* Subjects who have used any investigational medication within one month prior to study entry\n* Subjects who have been previously exposed to PDT and/or topical Levulan therapy for the treatment of actinic cheilitis\n* Subjects who have used local therapy (e.g. cryotherapy) or topical treatment (e.g. 5% fluorouracil) within three months of study entry\n* Subjects who have used an oral photosensitizing drug (e.g. Declomycin) within six months of study entry\n* Subjects who are currently using photosensitizing agents (e.g. thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the risk of augmented photosensitivity\n* Subjects who are frequently exposed to ultraviolet radiation (e.g. lifeguards, construction workers, frequent sunbed users, etc.)\n* Subjects with a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, or photodermatosis\n* Subjects with a known hypersensitivity to Levulan\n* Subjects who are immunocompromised'}, 'identificationModule': {'nctId': 'NCT02409732', 'briefTitle': 'Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis', 'orgStudyIdInfo': {'id': 'D15043 28525'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PDT', 'description': 'PDT with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks for up to three treatments', 'interventionNames': ['Drug: aminolevulinic acid hydrochloride', 'Procedure: Photodynamic therapy with blue light']}], 'interventions': [{'name': 'aminolevulinic acid hydrochloride', 'type': 'DRUG', 'otherNames': ['Levulan', 'aminolevulinic acid HCl'], 'armGroupLabels': ['PDT']}, {'name': 'Photodynamic therapy with blue light', 'type': 'PROCEDURE', 'otherNames': ['PDT with blue light', 'PDT'], 'armGroupLabels': ['PDT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Michael S Chapman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'DUSA Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Physician', 'investigatorFullName': 'Michael S. Chapman', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}