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

Study Overview
=================
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.

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

Conditions
-----------------
Skin Recovery in Different Human Skin Damage Models

Intervention / Treatment
-----------------
* Other: Hypericum perforatum oil
* Other: Placebo
* Procedure: SLS induced irritation
* Procedure: Tape-stripping
* Procedure: UV radiation
* Procedure: Intact skin


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypericum perforatum, Saint John's Wort, St. John's Wort