NCT03783819

Effects of Hypericum Perforatum Oil on Promoting Skin Recovery in Different Human Skin Damage Models

Completed NA Last updated 21 February 2020

What this trial tests

NA trial testing Hypericum perforatum oil in Skin Recovery in Different Human Skin Damage Models in 28 participants. Completed in 29 March 2019.

Timeline

4 February 2019

Primary endpoint
29 March 2019

29 March 2019

Quick facts

Lead sponsor	University of Split, School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	28
Start date	4 February 2019
Primary completion	29 March 2019
Estimated completion	29 March 2019
Sites	1 location across Croatia

Drugs / interventions tested

• Hypericum perforatum oil
• Placebo
• SLS induced irritation
• Tape-stripping
• UV radiation
• Intact skin

Conditions studied

• Skin Recovery in Different Human Skin Damage Models — all drugs for Skin Recovery in Different Human Skin Damage Models →

Sponsor

University of Split, School of Medicine

Who can join

Adults 18 to 60, any sex, with Skin Recovery in Different Human Skin Damage Models. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Measurement of Transepidermal Water Loss.
   Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148
2. Comparison of mechanical, chemical and physical human models of in vivo skin damage: Randomized controlled trial.
   Leskur D, Perišić I, Romac K, Šušak H, et al · · 2021 · cited 3× · PMID 32686217 · DOI 10.1111/srt.12932