A NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin Barrier
Status:
Unknown status
Trial end date:
2019-10-01
Target enrollment:
Participant gender:
Summary
Atopic dermatitis (AD) is among the most common chronic types of inflammatory skin disease
and it is characterised by exacerbations or relapses over years. The patients have a
genetically impaired skin barrier that can be evaluated by measuring the transepidermal water
loss (TEWL), which is increased in both dry skin and clinically normal skin in AD patients.
Moisturisers are first line treatment for AD patients and moisturisers are the most
prescribed products in dermatology. The use of moisturisers have been found to reduce the
need for steroids.
The newly developed moisturizing cream 1107.57 is intended for people with dry skin symptoms,
such as dryness, itching, and flaking. As most people with dry skin of different origin have
an impaired skin barrier function, it is important to investigate the possible influence on
the skin barrier after long-term (several weeks') treatment. It is of utmost importance to
evaluate different moisturisers head-to-head in order to facilitate an evidence-based choice
of moisturiser.
The primary objective of the trial is to determine whether applying the test cream 1107.57
for 4 weeks is superior in terms of skin barrier strengthening, when compared with (1) no
treatment and (2) two reference creams in adults with a predisposition to a skin barrier
defect. Secondary objectives are to determine whether there is a difference between 1107.57
and (1) no treatment and (2) the two reference creams in skin moisturization, tolerability,
cream consumption and safety.
Participants will treat their lower volar forearms for 28 days with three different creams
(test cream and two reference creams) and leave one area untreated as a control. Each forearm
will have two different treatment areas and treatment allocation will be randomized. One
Finger Tip Unit (FTU) of each cream will be applied twice daily on the designated study area
for 28 days. On day 1 and 29 the transepidermal water loss (TEWL) and skin capacitance is
measured on their forearms to evaluate the effect on skin barrier function and skin
hydration. Furthermore, on day 31, after challenge with 1 % sodium lauryl sulphate (SLS) on
day 29, the susceptibility to irritation caused by SLS will be evaluated visually and by
measuring TEWL on their forearms. Study participants will attend visits at the start of
randomised therapy and on day 5, 15, 29 and 31. During the study period the participants will
also grade and evaluate the tolerability of the different creams.