Irritation/IrritantNCT05276102

The Effects of Repeated Exposure to Antiseptics During COVID-19 Pandemic on Skin Parameters

A study testing Emollient cream in people with Irritation/Irritant and ICD - Irritant Contact Dermatitis, run by University of Split, School of Medicine at 1 site in Croatia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Irritation/Irritant, ICD - Irritant Contact Dermatitis, Antiseptic
What is being tested?: Emollient cream
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteCroatia
Study dates: 7 Mar 2022to 30 May 2022
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older 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 emollients three days prior the inclusion in the trial
non-adherence to the trial protocol
pregnancy and lactation
skin cancer
immunosuppression
exposure to artificial UV radiation

Trial locations and contacts

1 site in 1 country.

Croatia1 site, 1 recruiting

University of Split School of Medicine
Split, 21000
Dario Leskur, PhD, MPharm, +38521557851, dario.leskur@mefst.hr
Recruiting

Other trials in Croatia

About this study

The global coronavirus disease pandemic (COVID-19) has led to an increased need to wear protective equipment such as wearing face masks and practicing hygiene measures such as more frequent use of antiseptics. These measures can lead to changes in the skin, the development of new inflammatory skin diseases or exacerbation of existing ones, with health professionals especially under the risk of developing these changes. Changes in the skin of the hands due to the use of antiseptics have been observed in a number of studies, however, part of the study was based solely on subjects' self-assessment or clinical assessment of researchers, and only a small part on objective measurements of skin parameters. Also, the impact of prolonged use of antiseptics and the impact of measures to prevent and protect against irritation such as topical application of emollient preparations have not been investigated.

The impact of repeated use of antiseptics in the repeated exposure model on the forearms will be investigated. This model is a modification of the existing model of irritative dermatitis induced by sodium lauryl sulfate where the original irritant was replaced by an antiseptic solution.

Conditions: Irritation/Irritant, ICD - Irritant Contact Dermatitis, Antiseptic
Being tested: Emollient cream
Medical subject headings: Dermatitis, Irritant

What participants receive

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

Emollient creamOther
Commercially available emollient cream

Study groups in NCT05276102
Study group	Role	What they receive
Repated exposure to antiseptic and treatment	Active comparator	Repeated exposure of forearm skin to antiseptic (once daily for 2 hours under occlusion, during three weeks) Emollient cream treatment 3 times a day Receives: Other: Emollient cream
Sham irritation and treatment	Active comparator	Repeated exposure of forearm skin to deionized water (once daily for 2 hours under occlusion, during three weeks) Emollient cream treatment 3 times a day Receives: Other: Emollient cream
No irritation and treatment	Active comparator	Intact skin on forearms Emollient cream treatment 3 times a day Receives: Other: Emollient cream
Repated exposure to antiseptic and no treatment	No intervention	Repeated exposure of forearm skin to antiseptic (once daily for 2 hours under occlusion, during three weeks) No emollient cream treatment
Sham irritation and no treatment	No intervention	Repeated exposure of forearm skin to deionized water (once daily for 2 hours under occlusion, during three weeks) No emollient cream treatment
No irritation and no treatment	No intervention	Intact skin on forearms No emollient cream treatment

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: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
Stratum corneum hydration change
Corneometer will be used to estimate skin dryness. It is a relative measurement and uses arbitrary units (AU).
Measured: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
Erythema change
Mexameter will be used to assess erythema. It is a relative measurement and uses arbitrary units (AU).
Measured: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
Melanin content change
Mexameter will be used to assess skin melanin content. It is a relative measurement and uses arbitrary units (AU).
Measured: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
Clinical score
Skin response to irritation and treatment will be assessed using a five-point scale (0, 1/2, 1, 2 and 3) to describe changes in skin erythema, roughness, scaling, oedema, and fissures, with higher score signifying a worse outcome.
Measured: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks

Timeline

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

7 Mar 202230 May 2022

First posted11 Mar 2022
Study start7 Mar 2022
Primary completion30 May 2022 (estimated)
Study completion30 May 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Irritation/IrritantStudies 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
Model description: Each volar forearm of the participants will be divided in three sites, with each site randomly assigned to repeated exposure to antiseptic, repeated exposure to deionized water (sham irritation) or will be left intact. One forearm will be treated with the commercially available emollient three times a day while the other will be left untreated. Treated forearm (left or right) will be chosen according to randomization protocol (double randomization).
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05276102
Sponsor's protocol ID: 2181-198-03-04-22-0009
Status last verified: Mar 2022
First submitted: 10 Mar 2022
Last updated: 28 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Montero-Vilchez T, Cuenca-Barrales C, Martinez-Lopez A, Molina-Leyva A, Arias-Santiago S. Skin adverse events related to personal protective equipment: a systematic review and meta-analysis. J Eur Acad Dermatol Venereol. 2021 Oct;35(10):1994-2006. doi: 10.1111/jdv.17436. Epub 2021 Jun 29.
PubMed 34077565
Akl J, El-Kehdy J, Salloum A, Benedetto A, Karam P. Skin disorders associated with the COVID-19 pandemic: A review. J Cosmet Dermatol. 2021 Oct;20(10):3105-3115. doi: 10.1111/jocd.14266. Epub 2021 Jul 1.
PubMed 34077629
Elston DM. Occupational skin disease among health care workers during the coronavirus (COVID-19) epidemic. J Am Acad Dermatol. 2020 May;82(5):1085-1086. doi: 10.1016/j.jaad.2020.03.012. Epub 2020 Mar 18. No abstract available.
PubMed 32171807
Park SR, Han J, Yeon YM, Kang NY, Kim E. Effect of face mask on skin characteristics changes during the COVID-19 pandemic. Skin Res Technol. 2021 Jul;27(4):554-559. doi: 10.1111/srt.12983. Epub 2020 Nov 20.
PubMed 33217053
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

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Repeated Exposure to Antiseptics During COVID-19 Pandemic on Skin Parameters
ClinicalTrials.gov ID: NCT05276102
Acronym / sponsor ID: 2181-198-03-04-22-0009
Conditions: Irritation/Irritant, ICD - Irritant Contact Dermatitis, Antiseptic
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 20 participants (estimated)
Lead sponsor: University of Split, School of MedicineUniversity, hospital or other
Study start: 7 Mar 2022 (actual)
Primary completion: 30 May 2022 (estimated)
Study completion: 30 May 2022 (estimated)
First posted: 11 Mar 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 6
Model description: Each volar forearm of the participants will be divided in three sites, with each site randomly assigned to repeated exposure to antiseptic, repeated exposure to deionized water (sham irritation) or will be left intact. One forearm will be treated with the commercially available emollient three times a day while the other will be left untreated. Treated forearm (left or right) will be chosen according to randomization protocol (double randomization).

Arm	Type	Receives
Repated exposure to antiseptic and treatment	Active comparator	Other: Emollient creamRepeated exposure of forearm skin to antiseptic (once daily for 2 hours under occlusion, during three weeks) Emollient cream treatment 3 times a day
Sham irritation and treatment	Active comparator	Other: Emollient creamRepeated exposure of forearm skin to deionized water (once daily for 2 hours under occlusion, during three weeks) Emollient cream treatment 3 times a day
No irritation and treatment	Active comparator	Other: Emollient creamIntact skin on forearms Emollient cream treatment 3 times a day
Repated exposure to antiseptic and no treatment	No intervention	–Repeated exposure of forearm skin to antiseptic (once daily for 2 hours under occlusion, during three weeks) No emollient cream treatment
Sham irritation and no treatment	No intervention	–Repeated exposure of forearm skin to deionized water (once daily for 2 hours under occlusion, during three weeks) No emollient cream treatment
No irritation and no treatment	No intervention	–Intact skin on forearms No emollient cream treatment

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

young, healthy volunteers who gave written informed consent

Key exclusion criteria (8 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 emollients three days prior the inclusion in the trial
non-adherence to the trial protocol
pregnancy and lactation

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
Emollient creamCommercially available emollient cream	Other	No irritation and treatment, Repated exposure to antiseptic and treatment, Sham irritation and treatment

Primary outcome

Transepidermal water loss change
Time frame: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/hm2).
Stratum corneum hydration change
Time frame: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
Corneometer will be used to estimate skin dryness. It is a relative measurement and uses arbitrary units (AU).
Erythema change
Time frame: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
Mexameter will be used to assess erythema. It is a relative measurement and uses arbitrary units (AU).
Melanin content change
Time frame: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
Mexameter will be used to assess skin melanin content. It is a relative measurement and uses arbitrary units (AU).
Clinical score
Time frame: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
Skin response to irritation and treatment will be assessed using a five-point scale (0, 1/2, 1, 2 and 3) to describe changes in skin erythema, roughness, scaling, oedema, and fissures, with higher score signifying a worse outcome.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
Background: PubMed 34077565Montero-Vilchez T, Cuenca-Barrales C, Martinez-Lopez A, Molina-Leyva A, Arias-Santiago S. Skin adverse events related to personal protective equipment: a systematic review and meta-analysis. J Eur Acad Dermatol Venereol. 2021 Oct;35(10):1994-2006. doi: 10.1111/jdv.17436. Epub 2021 Jun 29.
Background: PubMed 34077629Akl J, El-Kehdy J, Salloum A, Benedetto A, Karam P. Skin disorders associated with the COVID-19 pandemic: A review. J Cosmet Dermatol. 2021 Oct;20(10):3105-3115. doi: 10.1111/jocd.14266. Epub 2021 Jul 1.
Background: PubMed 32171807Elston DM. Occupational skin disease among health care workers during the coronavirus (COVID-19) epidemic. J Am Acad Dermatol. 2020 May;82(5):1085-1086. doi: 10.1016/j.jaad.2020.03.012. Epub 2020 Mar 18. No abstract available.
Background: PubMed 33217053Park SR, Han J, Yeon YM, Kang NY, Kim E. Effect of face mask on skin characteristics changes during the COVID-19 pandemic. Skin Res Technol. 2021 Jul;27(4):554-559. doi: 10.1111/srt.12983. Epub 2020 Nov 20.
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.

University of Split School of Medicine

Split, Croatia

+38521557851

dario.leskur@mefst.hr

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

Questions about this trial

What is this clinical trial studying?

A study testing Emollient cream in people with Irritation/Irritant and ICD - Irritant Contact Dermatitis, run by University of Split, School of Medicine at 1 site in Croatia.

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 8 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: status not confirmed, as of the sponsor's last update on 28 Mar 2022. 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. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transepidermal water loss change (time frame: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks). The study lists 5 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 NCT05276102, which also lists 5 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 28 Mar 2022.