Skin Recovery in Different Human Skin Damage Models Clinical Trial
Official title:
Effects of Hypericum Perforatum Oil on Promoting Skin Recovery in Different Human Skin Damage Models, Randomized Controlled Trial
| Verified date | February 2020 |
| Source | University of Split, School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | March 29, 2019 |
| Est. primary completion date | March 29, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Croatia | School of Medicine | Split |
| Lead Sponsor | Collaborator |
|---|---|
| University of Split, School of Medicine |
Croatia,
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. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
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* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | |
| Primary | 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). | |
| Primary | 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). | |
| Primary | 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). |