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Effect of visible light on skin barrier recovery


- candidate number24665
- NTR NumberNTR5975
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jul-2016
- Secondary IDsNL56421.091.16 Philips Research
- Public TitleEffect of visible light on skin barrier recovery
- Scientific TitleEffects of visible light on inflammation and skin barrier recovery following acute perturbation. A pilot study
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedSkin barrier recovery
- Inclusion criteria- Age between 18 and 40 years;
- Subject must be willing to give a written informed consent;
- Subject 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 and conditions causing photosensitivity (e.g. porphyria, polymorphic light eruption, chronic actinic dermatitis, actinic prurigo and solar urticaria)
- 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);
- Use of medication with photosensitizing effects;
- Excessive sun exposure or tanning at the moment of screening.
In order to be compliant with the guidelines for the non-invasive biophysical skin measurements volunteers are also asked to:
- Avoid the application of creams, body lotions, other topicals on the skin sites to be assessed (volar forearms) on the days of the experiments and up to 24 hours before each visit.
- Avoid excessive sun exposure on the skin sites to be assessed on the days of the experiments.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 15-aug-2016
- planned closingdate
- Target number of participants40
- InterventionsVolunteers served as their own internal control.
Stimulation with tape stripping and histamine iontophoresis performed on the volar forearm, +/- followed by irradiation with visible light - then skin reactions are evaluated at different time points
- Primary outcomeMeasurement of Transepidermal Water Loss (TEWL) at baseline and at 1 hour, 24 hours and 72 hours after tape stripping.
- Secondary outcomeMeasurement of a* value at baseline and at 30 minues and 1h hour after histamine iontophoresis
- TimepointsDay 1, Day 2, Day 4, Day 8, Day 9, Day 11
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Celine Reverseau
- CONTACT for SCIENTIFIC QUERIES Celine Reverseau
- Sponsor/Initiator Philips Research Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Philips Research
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD20-jul-2016 - 31-aug-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl