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

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ClinicalTrials.gov Identifier: NCT03783819
Recruitment Status : Completed
First Posted : December 21, 2018
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
University of Split, School of Medicine

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.


Condition or disease Intervention/treatment Phase
Skin Recovery in Different Human Skin Damage Models Other: Hypericum perforatum oil Other: Placebo Procedure: SLS induced irritation Procedure: Tape-stripping Procedure: UV radiation Procedure: Intact skin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Hypericum Perforatum Oil on Promoting Skin Recovery in Different Human Skin Damage Models, Randomized Controlled Trial
Actual Study Start Date : February 4, 2019
Actual Primary Completion Date : March 29, 2019
Actual Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine


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.
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.




Primary Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783819


Locations
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Croatia
School of Medicine
Split, Croatia, 21000
Sponsors and Collaborators
University of Split, School of Medicine
Investigators
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Principal Investigator: Dario Leskur, MPharm University of Split, School of Medicine
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Split, School of Medicine
ClinicalTrials.gov Identifier: NCT03783819    
Other Study ID Numbers: 2181-198-03-01-18-0058
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Split, School of Medicine:
Hypericum perforatum
Saint John's Wort
St. John's Wort