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InflammationPhase 1NCT01762787

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

A Phase 1 study testing Cantharidin solution, Aspirin and Prednisolone in people with Inflammation, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Inflammation
What is being tested?
Cantharidin solution, Aspirin and Prednisolone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
17 Aug 2010to 14 Jan 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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 locations and contacts

1 site in 1 country.

United Kingdom1 site

  • GSK Investigational Site

    Cambridge, CB2 2GG

Other trials in United Kingdom

About this study

Official title: A Randomised, Single Blind, Placebo-Controlled, Cross-over, Phase 1 Methodology Study to Validate the Cantharidin Blister Model in Healthy Male Volunteers

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.

Read the detailed description

The purpose of this study is to refine the cantharidin-induced blister assay. The cantharidin-induced skin blister assay may be a valuable tool for evaluation of the pharmacodynamic effects of novel anti-inflammatory drugs in healthy volunteers, particularly for novel concepts targeting neutrophilic or monocytic inflammation. The study is an experimental trial in healthy volunteers for the purpose of evaluating the variability (between subjects and within subject) of the size and contents (cellular and fluid) of blisters induced on the forearm by direct application of cantharidin. Specifically, the aim is to assess whether variability is reduced in the current study, in which cantharidin will be applied directly to the skin in order to minimise the variation in total skin exposure. Once experimental design has been optimised then Part 2 of the study will examine the effects of a course of anti-inflammatory treatment prior to induction of blisters on the size and/or contents of blisters in a single blind crossover protocol.

Conditions
Inflammation
Being tested
Cantharidin solution, Aspirin, Prednisolone, Placebo to aspirin, Placebo to prednisolone
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cantharidin solutionDrug

    5 microlitres of 0.025 to 0.5% topically on Day 1, 2 and 3

  • AspirinDrug

    300mg three times daily orally over a course of 4 days (starting Day -3) Part 2 only

  • PrednisoloneDrug

    30mg orally once a day over a course of 4 days (starting Day -3) Part 2 only

  • Placebo to aspirinDrug

    0mg three times daily orally over a course of 4 days (starting Day -3) Part 2 only

  • Placebo to prednisoloneDrug

    0mg orally once a day over a course of 4 days (starting Day -3) Part 2 only

Study groups in NCT01762787
Study groupRoleWhat they receive
Effect of AspirinActive comparatorPositive control as previously used in the cantharidin blister experimental model of inflammation
Receives: Drug: Cantharidin solution; Drug: Aspirin; Drug: Placebo to aspirin
Effect of steroid - PrednisoloneExperimentalPrednisolone selected as steroids should provide the most robust positive control anti-inflammatory therapy
Receives: Drug: Cantharidin solution; Drug: Prednisolone; Drug: Placebo to prednisolone
Cantharidin exposure to optimise blister formationExperimentalCantharidin exposure to optimise blister formation
Receives: Drug: Cantharidin solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blister volume of fluid

    Volume of fluid extracted from blisters induced by cantharidin application

    Measured: 48 hours

  2. 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

    Measured: 48 hours

  3. 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.

    Measured: 48 hours

Secondary outcomes (5)

  1. Blister volume of fluid

    Volume of fluid extracted from blisters induced by cantharidin application

    Measured: 72 hours

  2. 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

    Measured: 72 hours

  3. 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.

    Measured: 72 hours

  4. Numbers and types of leukocytes in blood, and inflammatory mediators in plasma

    Measured: 72 hours

  5. Blister healing/skin appearance at 6 week follow up

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2013 (estimated)
  2. Study start17 Aug 2010
  3. Primary completion14 Jan 2011
  4. Study completion14 Jan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01762787
Sponsor's protocol ID
114416
Status last verified
Jun 2017
First submitted
28 Nov 2012
Last updated
28 Jun 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cantharidin solution, Aspirin and Prednisolone in people with Inflammation, run by GlaxoSmithKline at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blister volume of fluid (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01762787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.

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