Clinical TrialID 5397

Phase I Methodology Study to Validate the Cantharidin Blister Model in Healthy Volunteers

NCT01762787

Inflammation

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
5397
Evidence Id
5397
Core Evidence Id
5397
Source Clinical Trial Id
5382
Herb2 Clinical Trial Id
HBCT005382
Nct Id
NCT01762787
Title
Phase I Methodology Study to Validate the Cantharidin Blister Model in Healthy Volunteers
Status
Completed
Phase
Phase 1
Study Result
No
Study Condition
Inflammation
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Intervention
DRUG: Cantharidin solution|DRUG: Aspirin|DRUG: Prednisolone|DRUG: Placebo to aspirin|DRUG: Placebo to prednisolone
Intervention Allocation
Randomized
Intervention Model
Crossover
Intervention Mask
Single
Intervention Purpose
Other
Gender
Male
Age
Adult
Enrollment
40
Outcome Measure
Blister volume of fluid, Volume of fluid extracted from blisters induced by cantharidin application, 48 hours|Cell population in blister fluid, Flow cytometry performed on cells from blister fluid including measurement of some or all of the following parameters: CD45, CD16, CD14, cell viability, CD206, CD64 or CD84, apoptosis, total blister leukocytes (CD45+), monocytes (CD14+), neutrophils (CD16 high), monocyte/macrophage like cells (CD64+ or CD84+); subsets of these cells that are undergoing apoptosis; subsets of monocyte/macrophages, 48 hours|Inflammatory mediators in blister fluid, Inflammatory mediators in blister fluid, measured by immunoassay as primary endpoints may include (but will not be limited to): MPO, IL-10, IL-8, IL-6, IL-1β, TNF-α, LTB4., 48 hours
Sponsor Collaborator
GlaxoSmithKline
Funded By
INDUSTRY
Location
GSK Investigational Site, Cambridge, CB2 2GG, United Kingdom
Other Id
114416
Start Date
2010-08-17
Primary Completion Date
2011-01-14
Completion Date
2011-01-14
First Posted
2013-01-08
Results First Posted
Last Update Posted
2017-06-28
Study Document
Study Url
https://clinicaltrials.gov/study/NCT01762787
Title Cn
Title En
Phase I Methodology Study to Validate the Cantharidin Blister Model in Healthy Volunteers
Bilingual Status
semi_complete