crisaborole (2%) ointment on the other forearm, twice daily application for 4 weeks (randomised site allocation)
betamethasone valerate (0.1%) cream on one forearm, twice daily application for 4 weeks (randomised site allocation)

Atopic Eczema/Dermatitis (Non-Specific)

twice daily application on one forearm for 4 weeks (randomised site allocation)

crisaborole (2%) ointment

betamethasone valerate 0.1% cream

Atopic eczema in children - Guideline consultation: National Institute for Clinical Excellence, Department of Health, UK

Danby SG, Wan H, Chittock J et al. Characterisation of the skin barrier defect in atopic dermatitis using in vivo ATR-FTIR molecular spectroscopy. J Invest Dermatol 2016; 136: S182.

Lu Z, et al. Optical coherence tomography demonstrates differential epidermal thinning of human forearm volar skin after 2 weeks application of a topical corticosteroid vs a non-steroidal anti-inflammatory alternative. Proc. SPIE 2013; 85

Takada S, Naito S, Sonoda J et al. Noninvasive In Vivo Measurement of Natural Moisturizing Factor Content in Stratum Corneum of Human Skin by Attenuated Total Reflection Infrared Spectroscopy. Applied Spectroscopy 2012; 66: 26-32.

Sheffield Dermatology Research, University of Sheffield Medical School, The Royal Hallamshire Hospital

Skin bioMARkers for Atopic Eczema Therapy Evaluation

Validation of a Novel Composite of Skin Biomarkers as a Primary Outcome Measure for Evaluating the Safety of Treatments for Atopic Dermatitis: a Randomized Controlled Trial (Phase 2) Comparing the Effects of Crisaborole 2% Ointment to Betamethasone Valerate 0.1% Cream on Skin Structure and Function in Participants With Atopic Dermatitis.

The difference in the change in epidermal thickness (day 29 - day 1), measured by structural OCT, between the sites treated with crisaborole (2%) ointment and betamethasone valerate (0.1%) cream.

The difference in the change in epidermal thickness measured by structural OCT during and after 28 days treatment. OCT images of epidermal thickness taken on day 1, day 15, day 29 and day 57.

The difference in the change in skin redness/erythema (relating to tolerability) during and after 28 days treatment determined by:
Visual redness/erythema score determined on day 1, day 15, day 29 and day 57 Objective redness assessed with the Mexameter measured on day 1, day 15, day 29 and day 57

The difference in the change in Trans-Epidermal Water Loss (TEWL, relates to skin barrier function) during and after treatment.17,18 TEWL measurements on day 1, day 15, day 29 and day 57.

The difference in skin barrier integrity (TEWLts20) after 28 days treatment. TEWL measurements after tape-stripping (TEWLts20) on day 29

The difference in the change in visual skin dryness during and after treatment. Visual skin dryness scored on day 1, day 15, day 29 and day 57

The difference in Natural Moisturising Factor (NMF, filaggrin breakdown products) levels at the end of treatment19 NMF will be quantified from superficial stratum corneum samples collected on day 29 using HPLC

The difference in the change in superficial plexus depth (µm) measured by angiographic OCT

The difference in the change in mean blood vessel diameter (µm) measured by angiographic OCT

The difference in the change in blood vessel density (segments/mm2) measured by angiographic OCT

The difference in the change in collagen matrix index (an index derived from birefringence images of collagen density and arrangement) measured by polarisation sensitive (PS)-OCT

The difference in the change in carboxylate levels (indirect measure of NMF levels, not to be confused with direct quantification from stratum corneum samples by HPLC) in the stratum corneum measured by FTIR spectroscopy

The difference in stratum corneum lipid structure measured by FTIR spectroscopy in conjunction with tape-stripping

Number of FLG loss-of-function mutation carriers

Descriptive tabulations of TEWL by mutation status, if sufficient participants with mutation are detected.
All the above

Descriptive tabulations of epidermal thickness (structural OCT derived) by mutation status , if sufficient participants with mutation are detected.
All the above

Sheffield Teaching Hospitals NHS Foundation Trust

University of Sheffield

An observer-blind forearm-controlled clinical trial in 37 AD patients, wherein each participant will undergo 4 weeks treatment with crisaborole (2%) ointment on one forearm and betamethasone valerate (0.1%) cream on the other (twice daily application in each case and randomised site allocation). At the start of the study the skin of the test sites (forearms) will be clear of the signs of AD so that the investigation focuses on local adverse effects on the skin as opposed to anti-inflammatory effects (focus on local adverse effects and not clinical efficacy). The condition of the skin will be assessed before, during and after treatment.

Allocation of the treatments to the test sites (right/left forearm) will be randomised (to avoid site position-dependent artefacts) Observer-blind - The collection of study data will be conducted in a separate area (dedicated skin barrier research suite) by a separate team (comprising skilled dermatology researchers) who will be blind.

striae distensae/ατροφία

Skin bioMARkers for Atopic Eczema Therapy Evaluation

Η πληρέστερη βάση δεδομένων φαρμακευτικών βοτάνων που υποστηρίζεται από την επιστήμη