CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Hypericum perforatum oil +5 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03783819
NCT03783819N/ACompleted

Effects of Hypericum Perforatum Oil on Promoting Skin Recovery in Different Human Skin Damage Models, Randomized Controlled Trial

University of Split, School of Medicine·interventional·Posted Dec 21, 2018·Updated Feb 21, 2020

In Brief

A clinical study evaluating Hypericum perforatum oil, Placebo, and 4 other interventions for Skin Recovery in Different Human Skin Damage Models. Completed, enrolled 28 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCroatia
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 21, 2018
Enrollment StartFeb 4, 2019
Primary CompletionMar 29, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.5 years ago

Interventions

Hypericum perforatum oilother

Ointment containing Hypericum perforatum oil

Placeboother

Ointment containing plant oils used in Hypericum perforatum oil production and dye

SLS induced irritationprocedure

60 uL of 1% w/v sodium lauryl sulphate (SLS) will be applied to skin under occlusion by large Finn chamber for 24 hours as described in the guidelines by Standardization group of European Society of Contact Dermatitis. Procedure will be performed to specified skin sites, according to randomization protocol.

Tape-strippingprocedure

Skin barrier disruption will be induced by tape-stripping. Procedure will be performed to specified skin sites, according to randomization protocol.

UV radiationprocedure

UV radiation will be used to induce skin erythema and damage. Procedure will be performed to specified skin sites, according to randomization protocol.

Intact skinprocedure

Healthy, intact skin. Procedure will be performed to specified skin sites, according to randomization protocol.