The main objective is to evaluate the cytokine response to histamine iontophoresis in vivo, dynamically and non-invasively by means of transdermal analysis patches. The secondary objective is to correlate the cytokine response with morphological…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints are the levels of cytokines at baseline and at
different time points following local skin inflammation elicited by histamine
iontophoresis.
Secondary outcome
Not applicable.
Background summary
Cytokines are signalling molecules involved in the process of inflammation and
cutaneous irritation. A previous pilot study performed by our research group
showed that cytokines could be measured, in vivo and non-invasively, after
acute disruption of the skin barrier by means of repetitive application of an
adhesive tape (*tape stripping*). It would be interesting to evaluate whether
the profile of cytokine release is different if inflammation is elicited with
minimal skin barrier impairment by means of histamine iontophoresis. These
insights could be of interest in the field of transdermal drug delivery, in
which iontophoresis is frequently used to enhance the penetration of actives
through the skin.
Study objective
The main objective is to evaluate the cytokine response to histamine
iontophoresis in vivo, dynamically and non-invasively by means of transdermal
analysis patches. The secondary objective is to correlate the cytokine response
with morphological features of the skin obtained with reflectance confocal
microscopy (RCM).
Study design
This is a descriptive and exploratory pilot study.
Study burden and risks
Participation in the study does not lead to any short term benefit for the
volunteers. They are informed of this before giving informed consent. On the
long term, volunteers may benefit of better products/treatments created or
optimized starting from the insights into the inflammation and cutaneous
irritation following iontophoresis (e.g. new transdermal drug delivery systems)
gained within this and future studies. Volunteers need to visit the research
site (dermatology department of Radboud University Medical Center) two times.
On the first visit, histamine iontophoresis is performed on the volar forearm
and non-invasive evaluation is performed at two time points post stimulation.
The first visit lasts 1 hour and 40 minutes. The second visit takes place 24
hours or 72 hours after the first visit. During this 30 minutes-long visit the
skin on which histamine iontophoresis was performed is non-invasively
evaluated. The local skin inflammation elicited by histamine iontophoresis may
result in transient skin discomfort (itch, swelling and redness). From our
point of view, the short follow-up time, the minimally invasive stimulation
(histamine iontophoresis) and the non-invasive evaluation of the skin response
(cytokines and RCM) make participation to the study acceptable.
Rene Descartesdreef 1
Nijmegen 6500HB
NL
Rene Descartesdreef 1
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
Age between 18 and 65 years;
Must be willing to give a written informed consent;
Must have skin type I, II or III (Fitzpatrick scale).
Exclusion criteria
Diagnosis of histamine hypersensitivity;
Predisposition to respond allergic (including diagnosis of allergy to silver or to other device-related material);
Presence of cardiac pacemakers or other implanted electric devices;
Pregnancy or lactation;
Atopic predisposition (i.e. history of allergic rhinitis or allergic conjunctivitis, atopic or contact dermatitis, hay fever, asthma);
Any (skin) disease, including possible lesions found during screening;
Skin type IV, V, VI (Fitzpatrick scale);
Use of immunosuppressive drugs (NSAIDs; biologicals; topical or systemic corticosteroids);
Use of antihistamines drugs;
Use of medication for hypertension with airway constricting activity (e.g. beta blockers);
Excessive sun exposure or tanning at the moment of screening.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56943.091.16 |