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van CCT (UK)

van CCT (UK)

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- ISRCTNISRCTN no longer applicable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
- 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
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-aug-2016
- planned closingdate9-okt-2017
- Target number of participants44
- 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
- statusinclusion stopped: follow-up
- Sponsor/Initiator Philips Research Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Philips Research
- Publications
- Brief summaryRationale: Recent studies have demonstrated the presence of photoreceptors in the skin and suggest that visible (blue and red) light has biological effects in the skin, including decrease of inflammation, decrease of epidermal proliferation and enhancement of skin barrier repair. In this study we address the potential of red and blue light in fastening the recovery of skin homeostasis after experimentally-induced skin barrier disruption and inflammation. Light-based treatments/products could be developed starting from the outcomes of this study to diminish adverse skin reactions of people with sensitive skin.
Objective: The primary objective of this study is to evaluate whether the recovery of the skin barrier after acute perturbation by repetitive application of adhesive tape (“tape stripping”) is accelerated following irradiation with visible light. The secondary objective of this study is to evaluate whether the clearance of inflammation following application of histamine via iontophoresis is accelerated following irradiation with visible light. Four different irradiation settings will be employed and the primary and secondary objectives will be evaluated within each irradiation setting.
Study design: This is an observational case-control pilot study, where volunteers serve as their own internal control, performed at the dermatology department of Radboud University Medical Center.
Study population: 44 healthy human volunteers are included (divided in four groups of 11 people each, one group per irradiation setting), based on power analysis. Subjects must have skin type I, II or III (Fitzpatrick scale) and be 18 - 40 years old. Exclusion criteria include: 1. diagnosis of histamine hypersensitivity, 2. presence of cardiac pacemakers or other implanted electric devices, 3. pregnancy or lactation, 4. atopic predisposition (i.e. allergy, atopic/contact dermatitis, hay fever, asthma), 5. any current (skin) disease including conditions causing photosensitivity, 6. predisposition to respond allergic, 7. use of immunosuppressive drugs, 8. use of antihistamines drugs, 9. use of medication for hypertension with airway constricting activity, 10. use of medication with photosensitizing effects, 11. Skin type IV, V, VI (Fitzpatrick scale), 12. Excessive sun exposure or tanning less than 2 weeks before the beginning of the study.
Main study parameters/endpoints: The main study parameters are the recovery of the skin barrier after tape stripping, measured with transepidermal water loss (marker of skin barrier status), and the clearance of inflammation after histamine iontophoresis, measured with a* value (marker of skin redness). Both measurements are non-invasive. Tape stripping and histamine iontophoresis will be performed twice on the same volunteer, on two consecutive weeks. On one occasion stimulation is followed by irradiation, in the other no irradiation is performed serving as control.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study does not lead to any short term benefit for the volunteers, as clearly expressed in the information provided. On the long term, volunteers may benefit of better products/treatments created starting from the insights into the effects of visible light on skin homeostasis gained within this study. The study is performed on six visits spanned over two consecutive weeks. The study procedures are the same for each week: on the first visit, stimulation with tape stripping and histamine iontophoresis is performed on the volar forearm and skin reactions are evaluated up to 1 hour after stimulation. These are also evaluated later in the week, at 24 hours and 72 hours. The only difference is that, in one of the two weeks, stimulation is followed by irradiation with visible light. Total study duration for each volunteer is five hours. Stimulation may result in transient skin discomfort, itch and redness and last up to a few hours (histamine) and days (tape stripping). From our point of view, the short follow-up time, the minimally invasive stimulations and the non-invasive readouts make participation to the study acceptable.
- Main changes (audit trail)
- RECORD20-jul-2016 - 25-nov-2017

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