Last updated: 11/07/2018 04:53:33

Cantharidin-induced skin blister for testing anti-inflammatory effects of macrolides

GSK study ID
112593
See study documents
Clinicaltrials.gov ID
NCT01026064
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Utility of the cantharidin-induced skin blister assay for evaluation of anti-inflammatory effects of macrolides in healthy volunteers
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

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)

Timeframe: Study duration

Total cell count, neutrophil count and monocyte/macrophage count in blister fluid.

Timeframe: Part C: end of treatment and potentially 3 weeks later

Secondary outcomes:

Monocyte/macrophage phenotype in blister fluid.

Timeframe: Part C: end of treatment and potentially 3 weeks later

Inflammatory mediators in blister fluid.

Timeframe: Part C: end of treatment and potentially 3 weeks later

Markers of neutrophil activation.

Timeframe: Part C: end of treatment and potentially 3 weeks later

Inflammatory mediators in serum.

Timeframe: 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.

Timeframe: Part C: end of treatment and potentially 3 weeks later

Exploratory Outcome: Additional inflammatory mediators of interest may be determined.

Timeframe: Part C: end of treatment and potentially 3 weeks later

Interventions:
  • Other: Cantharidin
  • Drug: Azithromycin
  • Drug: Placebo
    • Enrollment:
    44
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    T Pene Dumitrescu, T Anic-Milic, K Oreskovic, J Padovan, KLR Brouwer, P Zuo, VD Schmith . Development of a Population Pharmacokinetic Model to Describe Azithromycin Whole Blood and Plasma Concentrations Over Time in Healthy Subjects. Antimicrob Agents Chemother. 2013;57(7):3194-3201.
    Medical condition
    Inflammation
    Product
    GR61229, azithromycin
    Collaborators
    GSK
    Study date(s)
    June 2009 to November 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • 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.
    • 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.
    Inclusion and exclusion criteria
    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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
    Status
    Recruiting
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    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
    2009-27-11

    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 112593 can be found on the GSK Clinical Study Register.
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