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

Overview

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.

Full Title of Study: “Effects of Hypericum Perforatum Oil on Promoting Skin Recovery in Different Human Skin Damage Models, Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 29, 2019

Interventions

  • Other: Hypericum perforatum oil
    • Ointment containing Hypericum perforatum oil
  • Other: Placebo
    • Ointment containing plant oils used in Hypericum perforatum oil production and dye
  • 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.

Arms, Groups and Cohorts

  • 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.
  • Placebo Comparator: Placebo treatment
    • Other forearm will be treated with placebo ointment. Forearm (left or right) will be chosen according to randomization protocol.

Clinical Trial Outcome Measures

Primary Measures

  • 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).
  • 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).
  • 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).
  • 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).

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Split, School of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dario Leskur, MPharm, Principal Investigator, University of Split, School of Medicine

References

Wölfle U, Seelinger G, Schempp CM. Topical application of St. John's wort (Hypericum perforatum). Planta Med. 2014 Feb;80(2-3):109-20. doi: 10.1055/s-0033-1351019. Epub 2013 Nov 8. Review.

Jarić S, Kostić O, Mataruga Z, Pavlović D, Pavlović M, Mitrović M, Pavlović P. Traditional wound-healing plants used in the Balkan region (Southeast Europe). J Ethnopharmacol. 2018 Jan 30;211:311-328. doi: 10.1016/j.jep.2017.09.018. Epub 2017 Sep 21. Review.

Schempp CM, Winghofer B, Lüdtke R, Simon-Haarhaus B, Schöpf E, Simon JC. Topical application of St John's wort (Hypericum perforatum L.) and of its metabolite hyperforin inhibits the allostimulatory capacity of epidermal cells. Br J Dermatol. 2000 May;142(5):979-84.

Davis J, Burr AR, Davis GF, Birnbaumer L, Molkentin JD. A TRPC6-dependent pathway for myofibroblast transdifferentiation and wound healing in vivo. Dev Cell. 2012 Oct 16;23(4):705-15. doi: 10.1016/j.devcel.2012.08.017. Epub 2012 Sep 27.

Süntar IP, Akkol EK, Yilmazer D, Baykal T, Kirmizibekmez H, Alper M, Yeşilada E. Investigations on the in vivo wound healing potential of Hypericum perforatum L. J Ethnopharmacol. 2010 Feb 3;127(2):468-77. doi: 10.1016/j.jep.2009.10.011. Epub 2009 Oct 13.

Thandar Y, Gray A, Botha J, Mosam A. Topical herbal medicines for atopic eczema: a systematic review of randomized controlled trials. Br J Dermatol. 2017 Feb;176(2):330-343. doi: 10.1111/bjd.14840. Epub 2016 Nov 30. Review.

Schempp CM, Windeck T, Hezel S, Simon JC. Topical treatment of atopic dermatitis with St. John's wort cream–a randomized, placebo controlled, double blind half-side comparison. Phytomedicine. 2003;10 Suppl 4:31-7.

Lavagna SM, Secci D, Chimenti P, Bonsignore L, Ottaviani A, Bizzarri B. Efficacy of Hypericum and Calendula oils in the epithelial reconstruction of surgical wounds in childbirth with caesarean section. Farmaco. 2001 May-Jul;56(5-7):451-3.

Samadi S, Khadivzadeh T, Emami A, Moosavi NS, Tafaghodi M, Behnam HR. The effect of Hypericum perforatum on the wound healing and scar of cesarean. J Altern Complement Med. 2010 Jan;16(1):113-7. doi: 10.1089/acm.2009.0317.

Hajhashemi M, Ghanbari Z, Movahedi M, Rafieian M, Keivani A, Haghollahi F. The effect of Achillea millefolium and Hypericum perforatum ointments on episiotomy wound healing in primiparous women. J Matern Fetal Neonatal Med. 2018 Jan;31(1):63-69. doi: 10.1080/14767058.2016.1275549. Epub 2017 Feb 23.

Läuchli S, Hafner J, Wehrmann C, French LE, Hunziker T. Post-surgical scalp wounds with exposed bone treated with a plant-derived wound therapeutic. J Wound Care. 2012 May;21(5):228, 230, 232-3.

Tupker RA, Willis C, Berardesca E, Lee CH, Fartasch M, Agner T, Serup J. Guidelines on sodium lauryl sulfate (SLS) exposure tests. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1997 Aug;37(2):53-69.

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