Effects of Hypericum Perforatum Oil on Promoting Skin Recovery in Different Human Skin Damage Models
Condition: Skin Recovery in Different Human Skin Damage Models
Study type: Interventional

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.
    


Intervention name(s): Hypericum perforatum oil; Placebo; SLS induced irritation; Tape-stripping; UV radiation; Intact skin
Intervention type(s): Other; Other; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Ointment containing Hypericum perforatum oil; Ointment containing plant oils used in Hypericum perforatum oil production and dye; 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.; Skin barrier disruption will be induced by tape-stripping. Procedure will be performed to specified skin sites, according to randomization protocol.; UV radiation will be used to induce skin erythema and damage. Procedure will be performed to specified skin sites, according to randomization protocol.; Healthy, intact skin. Procedure will be performed to specified skin sites, according to randomization protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypericum perforatum; Saint John's Wort; St. John's Wort