Skin blisters with systemic LPS or GM-CSF challenge
Research type
Research Study
Full title
An open label parallel group study to investigate the optimum methodology for the use of LPS or GM-CSF as challenge agents on healthy participants by assessing inflammatory biomarkers in cantharidin-induced skin blisters, peripheral blood, and urine
IRAS ID
223726
Contact name
Edward Banham-Hall
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development
Duration of Study in the UK
0 years, 10 months, 22 days
Research summary
It is possible to study human inflammatory mechanisms and how drugs modify inflammation by studying body fluids.
This study will investigate if exposure of healthy subjects to the established challenge agents, lipopolysaccharide (LPS) or Granulocyte–macrophage colony stimulating factor (GM-CSF), can be used to test the effect of drugs in future studies. LPS is a bacterial compound which triggers inflammation and GM-CSF is produced by immune system cells to enhance inflammatory responses.
This study involves testing blood, urine, and fluid from skin blisters before and after administering LPS or GM-CSF.
The study is split into 2 parts. In part 1, the challenge agent dose will be adjusted until the optimum dose is achieved. An estimated 24-30 (maximum of 40 including replacement for drop-out) healthy male volunteers may be included in Part 1. A further 8 participants may be dosed at the optimum dose in Part 2.
For both parts, participants will undergo the following procedures:
• A screening visit;
• Study session 1 - subjects will have two blisters induced on each forearm by application of small amounts of cantharidin (an agent that causes blisters) by trained professionals, followed by blood tests, urine collection and blister fluid collection;
• Study session 2 (after at least 14 days after session 1 to allow for blister healing) – subjects will be dosed with either LPS or GM-CSF, and have a further two blisters induced on each forearm (using cantharidin) then blood tests, urine collection and blister fluid collection;
• Two follow-up visits to confirm blister healing and volunteer wellbeing.
The duration of the study will be approximately 13 weeks including screening. Subjects will be monitored for safety throughout.
The study is sponsored by GSK and will be conducted in an MHRA accredited clinical research unit, with adequate safety facilities.REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0286
Date of REC Opinion
12 Jul 2017
REC opinion
Further Information Favourable Opinion