Last updated: 11/03/2018 16:36:52
Phase I Methodology Study to Validate the Cantharidin Blister Model in Healthy Volunteers
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomised, Single Blind, Placebo-Controlled, Cross-over, Phase 1 Methodology Study to validate the Cantharidin Blister Model in Healthy Male Volunteers
Trial description: The purpose of this study is to refine the cantharidin-induced blister assay in healthy volunteers as a model of inflammatory disease. The study is an experimental trial in healthy volunteers in two parts; Part 1 to optimise the model and Part 2 to validate using two anti-inflammatory treatments with different modes of action.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Blister volume of fluid
Timeframe: 48 hours
Cell population in blister fluid
Timeframe: 48 hours
Inflammatory mediators in blister fluid
Timeframe: 48 hours
Secondary outcomes:
Blister volume of fluid
Timeframe: 72 hours
Cell population in blister fluid
Timeframe: 72 hours
Inflammatory mediators in blister fluid
Timeframe: 72 hours
Numbers and types of leukocytes in blood, and inflammatory mediators in plasma
Timeframe: 72 hours
Blister healing/skin appearance at 6 week follow up
Timeframe: 6 weeks
Interventions:
Enrollment:
40
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Inflammation
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2010 to January 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital signs, complete blood count and clinical chemistry. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
- Male between 18 and 55 years of age inclusive, at the time of signing the informed consent
- Subjects with very fair or very dark skin type
- Presence on either forearm of tattoos, naevi, scars, keloids, hyperpigmentation, excessive hair or any skin abnormalities that may, in the opinion of the Investigator, interfere with study assessments
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital signs, complete blood count and clinical chemistry. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
- Male between 18 and 55 years of age inclusive, at the time of signing the informed consent
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Exclusion criteria:
- Subjects with very fair or very dark skin type
- Presence on either forearm of tattoos, naevi, scars, keloids, hyperpigmentation, excessive hair or any skin abnormalities that may, in the opinion of the Investigator, interfere with study assessments
- Subjects with a history of keloids, skin allergy, hypersensitivity or contact dermatitis, including previous reactions to dressings to be used in the study
- Subjects with a history of lymphangitis and/or lymphoedema
- Subjects with a history of HIV infection, hepatitis B or C
- A positive pre-study drug/alcohol screen
- Use of prescription or non-prescription drugs, including ergot derivatives e.g. dihydroergotamine (Dihydergot), vitamins, herbal and dietary supplements (including St John’s Wort) within whichever is the longer period of 7 days or 5 half-lives (if known) prior to the first challenge day, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56-day period For Part 2 only
- History of previous peptic ulcers, gastritis, GI bleed or history of bleeding problems, e.g. haemorrhoids or spontaneous nose bleeds
- Subjects with a history of asthma
- For aspirin only: History of sensitivity to aspirin or non steroidal anti-inflammatory drugs or a history of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor contraindicates their participation
- For prednisolone only: Subjects with systemic infections, hypersensitivity to any formulation ingredient, or ocular herpes simplex will be excluded. Those with, or a previous history of, tuberculosis, hypertension, congestive heart failure, liver failure, renal insufficiency, diabetes mellitus or in those with a family history of diabetes, osteoporosis, glaucoma or in those with a family history or glaucoma, subjects with a history of severe affective disorders and particularly those with a previous history of steroid-induced psychoses (in themselves or first degree relatives), epilepsy, peptic ulceration or previous steroid myopathy will also be excluded
- For prednisolone only: if a subject has not had chicken pox previously
- For prednisolone only: no live vaccines to be administered within 3 months of last prednisolone dose
- Subjects with a history of diabetes and peripheral vascular disease
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2011-14-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 114416 can be found on the GSK Clinical Study Register.
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