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Completed

NCT Number: NCT03783819

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

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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Key information

Conditions

Skin Recovery in Different Human Skin Damage Models

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medicine

Split, 21000, Croatia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hypericum perforatum oil

Other

Ointment containing Hypericum perforatum oil

Placebo

Other

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

SLS induced irritation

Procedure

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-stripping

Procedure

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

UV radiation

Procedure

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

Intact skin

Procedure

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

University of Split, School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2018
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.