- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01026064
Cantharidin-induced Skin Blister for Testing Anti-inflammatory Effects of Macrolides
July 24, 2017 updated by: GlaxoSmithKline
Utility of the Cantharidin-induced Skin Blister Assay for Evaluation of Anti-inflammatory Effects of Macrolides in Healthy Volunteers
The purpose of this study is to investigate the utility of the cantharidin-induced skin blister assay for evaluation of the anti-inflammatory effects of macrolides in healthy male volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will consist of 3 parts.
Part A of the study will assess the feasibility of different cantharidin blister induction/sampling timepoints (challenge options) ranging from 16/16 hours to 48/48 hours, including the ability to evaluate the acute and resolving phase of acute inflammation.
In Part A, 4 to 8 healthy male volunteers will be included.
This will be followed by Part B (in up to 12 subjects), aimed to select the optimum challenge option based on the reproducibility of read-outs across two challenge sessions.
This option will be applied in Part C in up to 24 subjects in order to evaluate the utility of the assay to demonstrate anti-inflammatory effects of a standard macrolide (azithromycin).
Part C is designed as a double-blind, placebo-controlled, parallel group trial.
Following the first cantharidin challenge and blister evaluation, subjects will be randomised in a 1:1 ratio to receive azithromycin or placebo.
Skin blister induction and assessment will be repeated immediately after treatment completion and, potentially, approximately 3 weeks later.
The inflammatory response to cantharidin and its modulation by azithromycin will be evaluated by total and differential cell counts in blister fluid, monocyte/macrophage phenotyping and the measurement of selected inflammation mediators in blister fluid and serum.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy as determined by a responsible and experienced physician.
- Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- The subject has a body weight of more than or equal to 50 kg and a BMI 18.5 to 30 kg/m2.
- 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 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 14 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 C only:
- QTcB or QTcF >450 msec, based on average QTc value of triplicate ECGs obtained over a brief recording period, if the first measurement shows abnormal QTc value.
- History of sensitivity to azithromycin, macrolide/ketolide antibiotics or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Part C- Azithromycin
2 x 250 mg once daily over 3 days
|
Cantharone topical liquid containing 0.7% cantharidin (blistering agent) is applied as 25 µL of 0.1% cantharone solution in acetone
Zithromax (250 mg oral capsule).
|
PLACEBO_COMPARATOR: Part C- Placebo
Once daily over 3 days
|
Matching placebo
Cantharone topical liquid containing 0.7% cantharidin (blistering agent) is applied as 25 µL of 0.1% cantharone solution in acetone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tolerability and safety of cantharidin-induced skin blister assay (as determined by AEs, pain intensity, systemic inflammatory response, healing time, and cosmetic appearance of blister area)
Time Frame: Study duration
|
Study duration
|
Total cell count, neutrophil count and monocyte/macrophage count in blister fluid.
Time Frame: Part C: end of treatment and potentially 3 weeks later
|
Part C: end of treatment and potentially 3 weeks later
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Monocyte/macrophage phenotype in blister fluid.
Time Frame: Part C: end of treatment and potentially 3 weeks later
|
Part C: end of treatment and potentially 3 weeks later
|
Inflammatory mediators in blister fluid.
Time Frame: Part C: end of treatment and potentially 3 weeks later
|
Part C: end of treatment and potentially 3 weeks later
|
Markers of neutrophil activation.
Time Frame: Part C: end of treatment and potentially 3 weeks later
|
Part C: end of treatment and potentially 3 weeks later
|
Inflammatory mediators in serum.
Time Frame: Part C: end of treatment and potentially 3 weeks later
|
Part C: end of treatment and potentially 3 weeks later
|
PK parameters for azithromycin in plasma and whole blood following the last dose of azithromycin, as well as azithromycin concentration in PMNs and, if possible, in peripheral blood mononuclear cells at selected time points.
Time Frame: Part C: end of treatment and potentially 3 weeks later
|
Part C: end of treatment and potentially 3 weeks later
|
Exploratory Outcome: Additional inflammatory mediators of interest may be determined.
Time Frame: Part C: end of treatment and potentially 3 weeks later
|
Part C: end of treatment and potentially 3 weeks later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 4, 2009
Primary Completion (ACTUAL)
November 27, 2009
Study Completion (ACTUAL)
November 27, 2009
Study Registration Dates
First Submitted
December 3, 2009
First Submitted That Met QC Criteria
December 3, 2009
First Posted (ESTIMATE)
December 4, 2009
Study Record Updates
Last Update Posted (ACTUAL)
July 25, 2017
Last Update Submitted That Met QC Criteria
July 24, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 112593
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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