Skin Recovery in Different Human Skin Damage Models Clinical Trial
Official title:
Effects of Hypericum Perforatum Oil on Promoting Skin Recovery in Different Human Skin Damage Models, Randomized Controlled Trial
Saint John's wort (Hypericum perforatum) was recognised as a traditional, folk medicine used
topically for the treatment of wounds, abrasions, burns, sunburns and inflammatory skin
disorders.
Its use in wound healing could be justified with its anti-inflammatory, antimicrobial and
astringent effects. It also stimulated tissue growth and cell differentiation, as one of
Hypericum perforatum's main ingredients, hyperforin, was shown to activate TRPC6 channel
which had been recognised as an activator of keratinocyte differentiation. Another
potentially useful activities could be its inhibitory effects on epidermal Langerhans cells.
Furthermore, in vivo research showed its potential with improved wound healing in different
rat models. Finally, several clinical studies were performed testing its effects in atopic
dermatitis treatment, wound healing after caesarean section and episiotomy, as well as
healing of post-surgical scalp wounds, bed sores and venous ulcers.
The aim of the study will be to determine the effectiveness of ointment containing Hypericum
perforatum oil on promoting skin recovery in different human skin damage models on healthy
volunteers, in comparison to placebo.
Chosen test sites will be the forearms. One forearm will be treated will the formulation
containing Hypericum perforatum oil while the other will be treated with the placebo
formulation. Four test sites will be marked on each forearm with skin barrier damage induced
on three areas while the fourth will be left intact. Treated forearm and test sites sequence
on forearms will be prospectively randomized (double randomization).
First skin damage model used in the trial will be sodium lauryl sulphate (SLS) induced
irritation. The SLS solution will be placed on the skin of participants under the occlusion
for 24 hours. Second model will be the tape-stripping procedure with defined TEWL value set
as an endpoint. The final model will be damage by the UV radiation. UV irradiation will be
performed under strict conditions with use of the necessary safety equipment. Only the
defined test areas will be irradiated with the defined dose of radiation.
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