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

February 20, 2020 updated by: University of Split, School of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Split, Croatia, 21000
        • School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- young, healthy volunteers who gave written informed consent

Exclusion Criteria:

  • skin disease, skin damage on measurement sites
  • use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
  • use of drugs that may cause photosensitivity
  • use of emollients three days prior the inclusion in the trial
  • non-adherence to the trial protocol
  • exposure to artificial and excessive natural UV radiation
  • pregnancy and lactation
  • skin cancer
  • history of vitiligo, melasma and other pigmentation and photosensitivity disorders
  • immunosuppression
  • allergic or irritant reactions to the constituents of the two ointments (active and placebo) and similar chemicals (e.g. salicylic and benzoic acid)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active treatment
One forearm will be treated with ointment containing Hypericum perforatum oil. Forearm (left or right) will be chosen according to randomization protocol.
Other: Hypericum perforatum oil
Ointment containing Hypericum perforatum oil
Procedure: SLS induced irritation
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.
Procedure: Tape-stripping
Skin barrier disruption will be induced by tape-stripping. Procedure will be performed to specified skin sites, according to randomization protocol.
Procedure: UV radiation
UV radiation will be used to induce skin erythema and damage. Procedure will be performed to specified skin sites, according to randomization protocol.
Procedure: Intact skin
Healthy, intact skin. Procedure will be performed to specified skin sites, according to randomization protocol.
Placebo Comparator: Placebo treatment
Other forearm will be treated with placebo ointment. Forearm (left or right) will be chosen according to randomization protocol.
Procedure: SLS induced irritation
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.
Procedure: Tape-stripping
Skin barrier disruption will be induced by tape-stripping. Procedure will be performed to specified skin sites, according to randomization protocol.
Procedure: UV radiation
UV radiation will be used to induce skin erythema and damage. Procedure will be performed to specified skin sites, according to randomization protocol.
Procedure: Intact skin
Healthy, intact skin. Procedure will be performed to specified skin sites, according to randomization protocol.
Other: Placebo
Ointment containing plant oils used in Hypericum perforatum oil production and dye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transepidermal water loss change
Time Frame: Assessments will be performed on 1st, 2nd, 3rd, 4th, 5th, 8th and 11th day of the trial (baseline measurements and change from baseline assessment).
Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/hm2).
Assessments will be performed on 1st, 2nd, 3rd, 4th, 5th, 8th and 11th day of the trial (baseline measurements and change from baseline assessment).
Stratum corneum hydration change
Time Frame: Assessments will be performed on 1st, 2nd, 3rd, 4th, 5th, 8th and 11th day of the trial (baseline measurements and change from baseline assessment).
Corneometer will be used to estimate skin dryness. It is a relative measurement and uses arbitrary units (AU).
Assessments will be performed on 1st, 2nd, 3rd, 4th, 5th, 8th and 11th day of the trial (baseline measurements and change from baseline assessment).
Erythema change
Time Frame: Assessments will be performed on 1st, 2nd, 3rd, 4th, 5th, 8th and 11th day of the trial (baseline measurements and change from baseline assessment).
Mexameter will be used to assess erythema. It is a relative measurement and uses arbitrary units (AU).
Assessments will be performed on 1st, 2nd, 3rd, 4th, 5th, 8th and 11th day of the trial (baseline measurements and change from baseline assessment).
Melanin content change
Time Frame: Assessments will be performed on 1st, 2nd, 3rd, 4th, 5th, 8th and 11th day of the trial (baseline measurements and change from baseline assessment).
Mexameter will be used to assess skin melanin content. It is a relative measurement and uses arbitrary units (AU).
Assessments will be performed on 1st, 2nd, 3rd, 4th, 5th, 8th and 11th day of the trial (baseline measurements and change from baseline assessment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Split, School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2019

Primary Completion (Actual)

March 29, 2019

Study Completion (Actual)

March 29, 2019

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

December 18, 2018

First Posted (Actual)

December 21, 2018

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2181-198-03-01-18-0058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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