The primary objective of this study is to detect significant difference in the average response to histamine, topically and iontophoretically applied to the skin, between sensitive and non-sensitive skin volunteers. Skin reactions are assessed with…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint consists in gaining insights into the differences in
the average responses to histamine, both topically and iontophoretically
applied, in sensitive and non-sensitive skin.
Secondary outcome
Not applicable.
Background summary
Sensitive skin has been defined as a subjective cutaneous hyper-reactivity to
stimuli, with or without objective signs of skin irritation. Subjective
sensations commonly present are itching, burning, stinging and tightness.
Despite the prevalence proves to be high across industrialized countries, no
consensus on the mechanisms involved has yet emerged. Gaining insights in the
mechanism(s) of sensitive skin has relevant importance from both a medical and
cosmetic perspective.
This study belongs to a wider project whose aim is to obtain an understanding
of sensitive skin in terms of key mechanism(s) involved. This task is carried
out through the use of different provocations to elicit skin reactions.
Provocations target mechanisms suggested to be involved in sensitive skin and
skin reactions are evaluated with different tools. This study focuses on
histamine iontophoretically and topically applied as provocations to be
included in the project.
Study objective
The primary objective of this study is to detect significant difference in the
average response to histamine, topically and iontophoretically applied to the
skin, between sensitive and non-sensitive skin volunteers. Skin reactions are
assessed with non-invasive methods like Visual Analogue Scale (VAS) scores,
skin photographs, clinical assessments and non-invasive biophysical skin
measurements, and with skin biopsies. Volunteers are included in the sensitive
or non-sensitive skin group according to a questionnaire.
Study design
This is a descriptive explorative pilot study.
Study burden and risks
Participation in the study does not lead to 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 and treatments created or
optimized starting from the insights into the mechanism(s) of sensitive skin
gained within this project.
Volunteers are asked to fill in a questionnaire about their skin sensitivity
and to visit the clinical site two or three times. The first visit (1.5 hours)
includes stimulation with histamine, which will be applied iontophoretically
and topically on the lower back and topically on the volar forearm. Evaluation
is performed at several time points and consists in measuring biophysical
parameters non-invasively, clinically assessing edema and erythema, taking skin
photographs, assessing the VAS score and taking one skin biopsy from a
non-stimulated skin spot on the lower back. Two other skin biopsies will be
taken at four different time points (1h, 8h, 24h and 72h) from the skin spot
stimulated with iontophoresis, according to a randomization process. Therefore,
the volunteers will need to visit the clinical site one or two other times and
each of these visits will take approximately 40 minutes. The stimulation with
histamine and the biopsies may result in skin discomfort. The risk of visible
scar formation is low, since the lesion is small. Considering this, we are of
the opinion that a study with short follow-up time and only minimally invasive
techniques is legitimate.
High Tech Campus 34
Eindhoven 5656AE
NL
High Tech Campus 34
Eindhoven 5656AE
NL
Listed location countries
Age
Inclusion criteria
Age between 18 and 65 years
Willing to give a written informed consent
Skin type II or III (Fitzpatrick scale)
Exclusion criteria
Diagnosis of histamine hypersensitivity
Diagnosis of silver allergy
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
Any bleeding disorder
Use of immunosuppressive drugs (NSAIDs; biologicals; topical or systemic corticosteroids)
Use of antihistamines drugs
Increased risk to develop hypertrophic scars
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 | NL49756.091.14 |