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

NCT03783819 | Completed

• 1 other identifier: 2181-198-03-01-18-0058
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Recovery in Different Human Skin Damage Models

Keywords

Hypericum perforatum; Saint John's Wort; St. John's Wort

Outcome Measures

Primary Outcomes (4)

• Transepidermal water loss change

  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

  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

  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

  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).

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

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; Procedure: SLS induced irritation; Procedure: Tape-stripping; Procedure: UV radiation; Procedure: Intact skin

Placebo treatment

PLACEBO COMPARATOR

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

Other: Placebo; Procedure: SLS induced irritation; Procedure: Tape-stripping; Procedure: UV radiation; Procedure: Intact skin

Interventions

Hypericum perforatum oil OTHER

Ointment containing Hypericum perforatum oil

Active treatment

Placebo OTHER

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

Placebo treatment

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.

Active treatment; Placebo treatment

Tape-stripping PROCEDURE

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

Active treatment; Placebo treatment

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.

Active treatment; Placebo treatment

Intact skin PROCEDURE

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

Active treatment; Placebo treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- young, healthy volunteers who gave written informed consent

You may not qualify if:

• skin disease, skin damage on measurement sites
• use of drugs that may cause photosensitivity
• 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)

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Study Sites (1)

School of Medicine

Split, 21000, Croatia

Location

Related Publications (13)

• Wolfle 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.

  PMID: 24214835 BACKGROUND

• Jaric S, Kostic O, Mataruga Z, Pavlovic D, Pavlovic M, Mitrovic M, Pavlovic 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.

  PMID: 28942136 BACKGROUND

• Schempp CM, Winghofer B, Ludtke R, Simon-Haarhaus B, Schopf 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. doi: 10.1046/j.1365-2133.2000.03482.x.

  PMID: 10809859 BACKGROUND

• 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.

  PMID: 23022034 BACKGROUND

• Suntar IP, Akkol EK, Yilmazer D, Baykal T, Kirmizibekmez H, Alper M, Yesilada 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.

  PMID: 19833187 BACKGROUND

• 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.

  PMID: 27373699 BACKGROUND

• 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. doi: 10.1078/1433-187x-00306.

  PMID: 12807340 BACKGROUND

• 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. doi: 10.1016/s0014-827x(01)01060-6.

  PMID: 11482776 BACKGROUND

• 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.

  PMID: 20064022 BACKGROUND

• 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.

  PMID: 28027682 BACKGROUND

• Lauchli 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. doi: 10.12968/jowc.2012.21.5.228.

  PMID: 22584740 BACKGROUND

• 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. doi: 10.1111/j.1600-0536.1997.tb00041.x.

  PMID: 9285167 BACKGROUND

• Leskur D, Perisic I, Romac K, Susak H, Seselja Perisin A, Bukic J, Rusic D, Kladar N, Bozin B, Modun D. Comparison of mechanical, chemical and physical human models of in vivo skin damage: Randomized controlled trial. Skin Res Technol. 2021 Mar;27(2):208-216. doi: 10.1111/srt.12932. Epub 2020 Jul 20.

  PMID: 32686217 DERIVED

MeSH Terms

Interventions

Hypericum extract LI 160; Ultraviolet Rays

Intervention Hierarchy (Ancestors)

Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Ionizing; Radiation, Nonionizing; Sunlight; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Dario Leskur, MPharm

  University of Split, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 21, 2018
• Study Start: February 4, 2019
• Primary Completion: March 29, 2019
• Study Completion: March 29, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

CR (1)