Skin Recovery in Different Human Skin Damage ModelsNCT03783819

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

A study testing Hypericum perforatum oil, SLS induced irritation and Tape-stripping in people with Skin Recovery in Different Human Skin Damage Models, run by University of Split, School of Medicine at 1 site in Croatia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Skin Recovery in Different Human Skin Damage Models
What is being tested?: Hypericum perforatum oil, SLS induced irritation and Tape-stripping
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 1 siteCroatia
Study dates: 4 Feb 2019to 29 Mar 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

young, healthy volunteers who gave written informed consent

Who cannot join

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

Show all 11Show fewer

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)

Trial locations and contacts

1 site in 1 country.

Croatia1 site

School of Medicine
Split, 21000

Other trials in Croatia

About this study

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

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
Being tested: Hypericum perforatum oil, Placebo, SLS induced irritation, Tape-stripping, UV radiation
Keywords: Hypericum perforatum, Saint John's Wort, St. John's Wort

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hypericum perforatum oilOther
Ointment containing Hypericum perforatum oil
PlaceboOther
Ointment containing plant oils used in Hypericum perforatum oil production and dye
SLS induced irritationProcedure or surgery
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.
Tape-strippingProcedure or surgery
Skin barrier disruption will be induced by tape-stripping. Procedure will be performed to specified skin sites, according to randomization protocol.
UV radiationProcedure or surgery
UV radiation will be used to induce skin erythema and damage. Procedure will be performed to specified skin sites, according to randomization protocol.
Intact skinProcedure or surgery
Healthy, intact skin. Procedure will be performed to specified skin sites, according to randomization protocol.

Study groups in NCT03783819
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Placebo; Procedure: SLS induced irritation; Procedure: Tape-stripping; Procedure: UV radiation; Procedure: Intact skin

What is being measured

The primary outcome is the main question the study is designed to answer.

Transepidermal water loss change
Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/hm2).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Assessments will be performed on 1st, 2nd, 3rd, 4th, 5th, 8th and 11th day of the trial (baseline measurements and change from baseline assessment).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 201929 Mar 2019

First posted21 Dec 2018
Study start4 Feb 2019
Primary completion29 Mar 2019
Study completion29 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Skin Recovery in Different Human Skin Damage ModelsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03783819
Sponsor's protocol ID: 2181-198-03-01-18-0058
Status last verified: Feb 2020
First submitted: 17 Dec 2018
Last updated: 21 Feb 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 24214835
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.
PubMed 28942136
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.
PubMed 10809859
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.
PubMed 23022034
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.
PubMed 19833187
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.
PubMed 27373699
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.
PubMed 12807340
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.
PubMed 11482776
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.
PubMed 20064022
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.
PubMed 28027682
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.
PubMed 22584740
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.
PubMed 9285167
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.
PubMed 32686217

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Hypericum Perforatum Oil on Promoting Skin Recovery in Different Human Skin Damage Models, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03783819
Acronym / sponsor ID: 2181-198-03-01-18-0058
Conditions: Skin Recovery in Different Human Skin Damage Models
Keywords: Hypericum perforatum, Saint John's Wort, St. John's Wort
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: University of Split, School of MedicineUniversity, hospital or other
Study start: 4 Feb 2019 (actual)
Primary completion: 29 Mar 2019 (actual)
Study completion: 29 Mar 2019 (actual)
First posted: 21 Dec 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active treatment	Active comparator	Other: Hypericum perforatum oil, Procedure: SLS induced irritation, Procedure: Tape-stripping, Procedure: UV radiation, Procedure: Intact skinOne forearm will be treated with ointment containing Hypericum perforatum oil. Forearm (left or right) will be chosen according to randomization protocol.
Placebo treatment	Placebo comparator	Other: Placebo, Procedure: SLS induced irritation, Procedure: Tape-stripping, Procedure: UV radiation, Procedure: Intact skinOther forearm will be treated with placebo ointment. Forearm (left or right) will be chosen according to randomization protocol.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

young, healthy volunteers who gave written informed consent

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hypericum perforatum oilOintment containing Hypericum perforatum oil	Other	Active treatment
PlaceboOintment containing plant oils used in Hypericum perforatum oil production and dye	Other	Placebo treatment
SLS induced irritation60 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 or surgery	Active treatment, Placebo treatment
Tape-strippingSkin barrier disruption will be induced by tape-stripping. Procedure will be performed to specified skin sites, according to randomization protocol.	Procedure or surgery	Active treatment, Placebo treatment
UV radiationUV radiation will be used to induce skin erythema and damage. Procedure will be performed to specified skin sites, according to randomization protocol.	Procedure or surgery	Active treatment, Placebo treatment
Intact skinHealthy, intact skin. Procedure will be performed to specified skin sites, according to randomization protocol.	Procedure or surgery	Active treatment, Placebo treatment

Primary outcome

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).
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).
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).
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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
Background: PubMed 24214835Wolfle 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.
Background: PubMed 28942136Jaric 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.
Background: PubMed 10809859Schempp 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.
Background: PubMed 23022034Davis 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.
Background: PubMed 19833187Suntar 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.
Background: PubMed 27373699Thandar 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.
Background: PubMed 12807340Schempp 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.
Background: PubMed 11482776Lavagna 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.
Background: PubMed 20064022Samadi 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.
Background: PubMed 28027682Hajhashemi 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.
Background: PubMed 22584740Lauchli 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.
Background: PubMed 9285167Tupker 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.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dario Leskur, MPharm principal investigator

University of Split, School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03783819, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.