Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-04-16 @ 11:11 PM
Study NCT ID:
NCT02015195
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2013-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effective Treatments for Jellyfish Stings
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D004890', 'term': 'Erythema'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019342', 'term': 'Acetic Acid'}, {'id': 'D000641', 'term': 'Ammonia'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D019840', 'term': '2-Propanol'}], 'ancestors': [{'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000438', 'term': 'Alcohols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'auerbach@stanford.edu', 'phone': '650.725.9445', 'title': 'Paul Auerbach, MD', 'organization': 'Division of Emergency Medicine, Department of Surgery, Stanford University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Acetic Acid 5%', 'description': 'Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nAcetic Acid (5%)\n\nNo treatment', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sodium Bicarbonate Slurry (50%)', 'description': 'Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nSodium Bicarbonate Slurry (50%)\n\nNo treatment', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Papain Slurry (70%)', 'description': 'Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nPapain Slurry (70%)\n\nNo treatment', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Household Ammonia (10%)', 'description': 'Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nAmmonia (10%)\n\nNo treatment\n\nThe first patient treated had an adverse local skin reaction, so this study arm was discontinued', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Lidocaine (4%)', 'description': 'Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nLidocaine (4%)\n\nNo treatment', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Isopropyl Alcohol (70%)', 'description': 'Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nIsopropyl Alcohol (70%)\n\nNo treatment', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Hot Water (40 Degrees Celsius)', 'description': 'Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nHot Tap Water (40 degrees Celsius)\n\nNo treatment', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'erythema', 'notes': 'erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'pain'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetic Acid 5%', 'description': 'Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nAcetic Acid (5%)\n\nNo treatment'}, {'id': 'OG001', 'title': 'Sodium Bicarbonate Slurry (50%)', 'description': 'Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nSodium Bicarbonate Slurry (50%)\n\nNo treatment'}, {'id': 'OG002', 'title': 'Papain Slurry (70%)', 'description': 'Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nPapain Slurry (70%)\n\nNo treatment'}, {'id': 'OG003', 'title': 'Lidocaine (4%)', 'description': 'Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nLidocaine (4%)\n\nNo treatment'}, {'id': 'OG004', 'title': 'Isopropyl Alcohol (70%)', 'description': 'Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nIsopropyl Alcohol (70%)\n\nNo treatment'}, {'id': 'OG005', 'title': 'Hot Water (40 Degrees Celsius)', 'description': 'Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nHot Tap Water (40 degrees Celsius)\n\nNo treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '-0.31', 'upperLimit': '0.55'}, {'value': '-0.19', 'groupId': 'OG001', 'lowerLimit': '-0.63', 'upperLimit': '0.25'}, {'value': '-0.46', 'groupId': 'OG002', 'lowerLimit': '-0.90', 'upperLimit': '-0.01'}, {'value': '-0.31', 'groupId': 'OG003', 'lowerLimit': '-0.76', 'upperLimit': '0.126'}, {'value': '-0.26', 'groupId': 'OG004', 'lowerLimit': '-0.70', 'upperLimit': '0.17'}, {'value': '0.42', 'groupId': 'OG005', 'lowerLimit': '-0.02', 'upperLimit': '0.87'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Pain is measured on a scale of 1-10 with 0 being no pain and 10 being worse pain ever felt. Baseline pain will be measured immediately after being stung for 2 minutes without any treatment. Subsequent pain felt at every 2 minutes for 30 minutes, at 1 hour post sting, and at 24 hours post sting will be based on changes from the original baseline pain. Mean change is defined as the mean change in pain from all time points measured from each participant and then averaged for each group. The control arm (placebo) was collected and analyzed in parallel to the treatment arm. The "mean change" for the treatment arm was then compared with the "mean change" for the control arm as a baseline. Hence, the data presented are the estimated effect for each treatment group compared to the control arms for each group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'one participant excluded because of adverse local skin reaction to household ammonia'}, {'type': 'PRIMARY', 'title': 'Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetic Acid 5%', 'description': 'Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nAcetic Acid (5%)\n\nNo treatment'}, {'id': 'OG001', 'title': 'Sodium Bicarbonate Slurry (50%)', 'description': 'Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nSodium Bicarbonate Slurry (50%)\n\nNo treatment'}, {'id': 'OG002', 'title': 'Papain Slurry (70%)', 'description': 'Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nPapain Slurry (70%)\n\nNo treatment'}, {'id': 'OG003', 'title': 'Lidocaine (4%)', 'description': 'Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nLidocaine (4%)\n\nNo treatment'}, {'id': 'OG004', 'title': 'Isopropyl Alcohol (70%)', 'description': 'Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nIsopropyl Alcohol (70%)\n\nNo treatment'}, {'id': 'OG005', 'title': 'Hot Water (40 Degrees Celsius)', 'description': 'Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nHot Tap Water (40 degrees Celsius)\n\nNo treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '4.43', 'groupId': 'OG000', 'lowerLimit': '-3.52', 'upperLimit': '12.39'}, {'value': '-12.07', 'groupId': 'OG001', 'lowerLimit': '-19.26', 'upperLimit': '-4.88'}, {'value': '0.58', 'groupId': 'OG002', 'lowerLimit': '-7.37', 'upperLimit': '8.55'}, {'value': '-4.14', 'groupId': 'OG003', 'lowerLimit': '-11.56', 'upperLimit': '3.27'}, {'value': '2.11', 'groupId': 'OG004', 'lowerLimit': '-5.84', 'upperLimit': '10.07'}, {'value': '-4.11', 'groupId': 'OG005', 'lowerLimit': '-11.79', 'upperLimit': '3.56'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes, 1 hour, and 24 hours', 'description': 'Visual inspection of sting sites will be done at 30 minutes post sting (after treatment completed), 1 hour post sting, and 24 hours post sting. Erythema Index (EI) imeasures increase in cutaneous vasodilation. A computer-measured (Image-J software) EI was used to remove subjectivity. A numeric score was created for the level of erythema, with "0" representing baseline erythema on the control arm. Any positive number indicates more and negative number less erythema on treatment arm compared to placebo. EI values were measured on a "scale" from -20 to +20 with "0" being the midpoint where there would be equal amounts of erythema on both the treatment and control arm. The erythema they experienced on the "treatment arm" was then measured as more erythema (a positive value up to 20) or less erythema (a negative value up to -20).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acetic Acid 5%', 'description': 'Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nAcetic Acid (5%)\n\nNo treatment\n\nThe left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).'}, {'id': 'FG001', 'title': 'Sodium Bicarbonate Slurry (50%)', 'description': 'Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nSodium Bicarbonate Slurry (50%)\n\nNo treatment\n\nThe left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).'}, {'id': 'FG002', 'title': 'Papain Slurry (70%)', 'description': 'Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nPapain Slurry (70%)\n\nNo treatment\n\nThe left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).'}, {'id': 'FG003', 'title': 'Household Ammonia (10%)', 'description': 'Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nAmmonia (10%)\n\nNo treatment\n\nThe left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).'}, {'id': 'FG004', 'title': 'Lidocaine (4%)', 'description': 'Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nLidocaine (4%)\n\nNo treatment\n\nThe left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).'}, {'id': 'FG005', 'title': 'Isopropyl Alcohol (70%)', 'description': 'Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nIsopropyl Alcohol (70%)\n\nThe left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).\n\nNo treatment'}, {'id': 'FG006', 'title': 'Hot Water (40 Degrees Celsius)', 'description': 'Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nHot Tap Water (40 degrees Celsius)\n\nNo treatment\n\nThe left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '16'}, {'groupId': 'FG006', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '16'}, {'groupId': 'FG006', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Healthy human subjects were recruited by advertisement on Stanford University campus during the months of May and June, 2013 for a study that took place within a medical ward within a hospital during July, 2013. 97 patients were enrolled.', 'preAssignmentDetails': 'Volunteers were excluded if they were pregnant, had a history of allergic reaction to prior jellyfish or insect sting, a family history of severe allergic reaction to jellyfish or insect sting, or a history of heart or lung disease.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '97', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Acetic Acid 5%', 'description': 'Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nAcetic Acid (5%)\n\nNo treatment\n\n11 males, 5 females treated'}, {'id': 'BG001', 'title': 'Sodium Bicarbonate Slurry (50%)', 'description': 'Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nSodium Bicarbonate Slurry (50%)\n\nNo treatment\n\n8 males, 8 females treated'}, {'id': 'BG002', 'title': 'Papain Slurry (70%)', 'description': 'Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nPapain Slurry (70%)\n\nNo treatment\n\n9 males, 7 females treated'}, {'id': 'BG003', 'title': 'Household Ammonia (10%)', 'description': 'Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nAmmonia (10%)\n\nNo treatment\n\n1 female treated; adverse local skin reaction; study arm therefore withdrawn'}, {'id': 'BG004', 'title': 'Lidocaine (4%)', 'description': 'Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nLidocaine (4%)\n\nNo treatment\n\n10 males, 6 females treated'}, {'id': 'BG005', 'title': 'Isopropyl Alcohol (70%)', 'description': 'Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nIsopropyl Alcohol (70%)\n\nNo treatment\n\n8 makes, 8 females treated'}, {'id': 'BG006', 'title': 'Heated Water (40 Degrees Celsius)', 'description': 'Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes\n\nHeated Tap Water (40 degrees Celsius)\n\nNo treatment\n\n8 males, 8 females treated'}, {'id': 'BG007', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '97', 'groupId': 'BG007'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '43', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '54', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '97', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'one patient treated with ammonia - adverse local skin reaction - this treatment arm therefore withdrawn from study'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-10', 'studyFirstSubmitDate': '2013-12-04', 'resultsFirstSubmitDate': '2015-01-26', 'studyFirstSubmitQcDate': '2013-12-12', 'lastUpdatePostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-10', 'studyFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours', 'timeFrame': '24 hours', 'description': 'Pain is measured on a scale of 1-10 with 0 being no pain and 10 being worse pain ever felt. Baseline pain will be measured immediately after being stung for 2 minutes without any treatment. Subsequent pain felt at every 2 minutes for 30 minutes, at 1 hour post sting, and at 24 hours post sting will be based on changes from the original baseline pain. Mean change is defined as the mean change in pain from all time points measured from each participant and then averaged for each group. The control arm (placebo) was collected and analyzed in parallel to the treatment arm. The "mean change" for the treatment arm was then compared with the "mean change" for the control arm as a baseline. Hence, the data presented are the estimated effect for each treatment group compared to the control arms for each group.'}, {'measure': 'Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours', 'timeFrame': '30 minutes, 1 hour, and 24 hours', 'description': 'Visual inspection of sting sites will be done at 30 minutes post sting (after treatment completed), 1 hour post sting, and 24 hours post sting. Erythema Index (EI) imeasures increase in cutaneous vasodilation. A computer-measured (Image-J software) EI was used to remove subjectivity. A numeric score was created for the level of erythema, with "0" representing baseline erythema on the control arm. Any positive number indicates more and negative number less erythema on treatment arm compared to placebo. EI values were measured on a "scale" from -20 to +20 with "0" being the midpoint where there would be equal amounts of erythema on both the treatment and control arm. The erythema they experienced on the "treatment arm" was then measured as more erythema (a positive value up to 20) or less erythema (a negative value up to -20).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Jellyfish stings', 'Treatment', 'Humans', 'Topical Treatments', 'Pain', 'Erythema'], 'conditions': ['Jellyfish Stings']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to attempt to determine which treatment from commonly used treatments is the best at reducing pain and redness of the skin after a sting from a Portuguese Man of War, Chrysaora chinensis, or Chrysaora fuscescens.\n\nJellyfish stings are a common occurrence in many parts of the world causing significant morbidity to persons stung by jellyfish while participating in marine activities whether commercial or recreational. Much debate and confusion exist both in the medical literature and the common recommendations regarding how to treat persons stung by jellyfish. Specifically concerning what topical treatments are most efficacious at decreasing envenomation by nematocyst on skin, preventing the firing of un-discharged nematocyst, decreasing inflammation and pain resulting from envenomation by nematocyst. Antidotal recommendations and past studies have referenced numerous different topical treatments for jellyfish stings including but not limited to vinegar, urine, alcohol, distilled spirits, ammonia, bleach, acetone, bicarbonate slurry, lidocaine, meat tenderizer, Coca Cola, old wine, salt water, cold packs, hot water, and commercial products such as Stingose and Stingaid. Conflicting data exists regarding what works and what does not for nematocysts discharge, skin erythema, and pain reaction.\n\nThe investigators would like to investigate which treatment is best out of some of the more commonly studied treatments for reducing pain and erythema.\n\nThe investigators would like to complete a research study to try to bring some reasonable evidence to the field treatment of jellyfish stings, namely, the decontamination process (e.g., what can you put on a jellyfish sting that will be helpful, based on real data?).\n\nThe questions asked are as follows:\n\n* What topical treatments for jellyfish stings actually decrease the amount of inflammation seen on a macroscopic level on the skin of humans?\n* What topical treatments for jellyfish stings actually decrease the sensation of pain in humans?\n* Do topical chemical treatments cause different outcomes when exposed to the above parameters?\n* Do different species of jellyfish nematocysts react differently based on the type of topical chemical treatment used? What is the variation of effects of topical treatments based on the species of jellyfish sting?\n\nSpecifically, the investigators will be stinging human subject on both arms with a segment of tentacle for approximately 2 minutes. This will be followed by no treatment on one arm (control arm) and by treatment on the other arm with either: acetic acid (5%), sodium bicarbonate slurry (50%), papain slurry (70%), ammonia (10%), viscous lidocaine (4%), isopropyl alcohol (70%), or hot tap water (40 degrees Celsius). Outcomes measured will include pain and erythema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-65 years\n* Healthy volunteers\n\nExclusion Criteria:\n\n* Known history of allergic reaction or anaphylaxis to prior Cnidaria sting of there envenomations\n* Family history of anaphylaxis to any sting from either Cnidaria, bee, or wasp\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02015195', 'briefTitle': 'Effective Treatments for Jellyfish Stings', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Efficacy of Topical Agents in the Treatment of Chrysaora Chinensis Stings', 'orgStudyIdInfo': {'id': 'JSP-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acetic Acid 5%', 'description': 'Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes', 'interventionNames': ['Other: Acetic Acid (5%)', 'Other: No treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Sodium Bicarbonate Slurry (50%)', 'description': 'Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes', 'interventionNames': ['Other: Sodium Bicarbonate Slurry (50%)', 'Other: No treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Papain Slurry (70%)', 'description': 'Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes', 'interventionNames': ['Other: Papain Slurry (70%)', 'Other: No treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Household ammonia (10%)', 'description': 'Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes', 'interventionNames': ['Other: Ammonia (10%)', 'Other: No treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine (4%)', 'description': 'Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes', 'interventionNames': ['Drug: Lidocaine (4%)', 'Other: No treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Isopropyl Alcohol (70%)', 'description': 'Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes', 'interventionNames': ['Other: Isopropyl Alcohol (70%)', 'Other: No treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Hot Water (40 degrees Celsius)', 'description': 'Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes', 'interventionNames': ['Other: Hot Tap Water (40 degrees Celsius)', 'Other: No treatment']}], 'interventions': [{'name': 'Acetic Acid (5%)', 'type': 'OTHER', 'otherNames': ['Vinegar'], 'armGroupLabels': ['Acetic Acid 5%']}, {'name': 'Sodium Bicarbonate Slurry (50%)', 'type': 'OTHER', 'armGroupLabels': ['Sodium Bicarbonate Slurry (50%)']}, {'name': 'Papain Slurry (70%)', 'type': 'OTHER', 'otherNames': ["Adolfo's Meat tenderizer"], 'armGroupLabels': ['Papain Slurry (70%)']}, {'name': 'Ammonia (10%)', 'type': 'OTHER', 'otherNames': ['Household ammonia'], 'armGroupLabels': ['Household ammonia (10%)']}, {'name': 'Lidocaine (4%)', 'type': 'DRUG', 'otherNames': ['Liquid Lidocaine'], 'armGroupLabels': ['Lidocaine (4%)']}, {'name': 'Isopropyl Alcohol (70%)', 'type': 'OTHER', 'otherNames': ['Rubbing alcohol'], 'armGroupLabels': ['Isopropyl Alcohol (70%)']}, {'name': 'Hot Tap Water (40 degrees Celsius)', 'type': 'OTHER', 'otherNames': ['Hot Water'], 'armGroupLabels': ['Hot Water (40 degrees Celsius)']}, {'name': 'No treatment', 'type': 'OTHER', 'otherNames': ['Nothing is given topically to treat sting. This is the control.'], 'armGroupLabels': ['Acetic Acid 5%', 'Hot Water (40 degrees Celsius)', 'Household ammonia (10%)', 'Isopropyl Alcohol (70%)', 'Lidocaine (4%)', 'Papain Slurry (70%)', 'Sodium Bicarbonate Slurry (50%)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Paul S Auerbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Emergency Medicine, Stanford University Medical Center'}, {'name': 'Matthieu P DeClerck, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Division of Emergency Medicine, Stanford University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Paul S Auerbach', 'investigatorAffiliation': 'Stanford University'}}}}