Contact DermatitisNCT06189144
Testing an Intervention in Irritative Contact Dermatitis
A study testing Emollient cream treatment and no treatment in people with Contact Dermatitis and Contact Dermatitis Irritant, run by University of Split, School of Medicine at 1 site in Croatia.
Trial summary
An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Contact Dermatitis, Contact Dermatitis Irritant
- What is being tested?
- Emollient cream treatment and no treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jun 2023to 1 Jun 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy volunteers who gave written informed consent
Who cannot join
- · skin cancer
- 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
Show all 12Show fewer
- non-adherence to the trial protocol
- exposure to artificial and excessive natural ultraviolet (UV) radiation
- pregnancy and lactation
- history of vitiligo, melasma and other pigmentation and photosensitivity disorders
- immunosuppression
- allergic or irritant reactions to the constituents of the cream
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
School of Medicine
Split, 21000
Dario Leskur, MPharm, +38521557868, dario.leskur@mefst.hr
Darko Modun, MD, PhD, +38521557851, darko.modun@mefst.hr
About this study
Official title: Testing the Effectiveness of an Intervention in Irritative Contact Dermatitis:Randomized Controlled Trial
An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system.
Read the detailed description
An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system. Therefore, the aim of this study was to see if omega cream, as proposed by its mechanism of action, could improve SLS induced contact dermatitis.
- Conditions
- Contact Dermatitis, Contact Dermatitis Irritant
- Being tested
- Emollient cream treatment, no treatment
- Medical subject headings
- Dermatitis, Contact, Dermatitis, Irritant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emollient cream treatmentOther
Rilastil Difesa Sterile cream
no treatmentOther
no treatment
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | SLS irritation model and Treatment Receives: Other: Emollient cream treatment |
| placebo comparator | Placebo comparator | SLS irritation model and No Treatment Receives: Other: no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEWL measurement with Khazaka probe
Transepidermal water loss
Measured: through study completion, an average of 1 year
hydration measurement with corneometer probe
corneometer assessed stratum corneum hydration level
Measured: through study completion, an average of 1 year
erythema measured with mexameter
mexameter assessed redness
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
clinical score according to dermatologist scale
Skin response to irritation and treatment will be assessed using a five-point scale to describe changes in skin erythema, roughness, scaling, oedema, and fissure
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Jun 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact DermatitisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dario Leskur, University of Split, School of Medicine
- Investigators
- josipa bukic, Study chair, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189144
- Sponsor's protocol ID
- 2181-L98-03-04-23-0030
- Status last verified
- Dec 2023
- First submitted
- 13 Sep 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of an Intervention in Irritative Contact Dermatitis:Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06189144
- Acronym / sponsor ID
- 2181-L98-03-04-23-0030
- Conditions
- Contact Dermatitis, Contact Dermatitis Irritant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 3 Jan 2024 (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.
An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system.
Detailed description
An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system. Therefore, the aim of this study was to see if omega cream, as proposed by its mechanism of action, could improve SLS induced contact dermatitis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Other: Emollient cream treatmentSLS irritation model and Treatment |
| placebo comparator | Placebo comparator | Other: no treatmentSLS irritation model and No Treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers who gave written informed consent
Key exclusion criteria (12 listed)
- · skin cancer
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 cream treatmentRilastil Difesa Sterile cream | Other | experimental arm |
| no treatmentno treatment | Other | placebo comparator |
Primary outcome
TEWL measurement with Khazaka probe
Time frame: through study completion, an average of 1 year
Transepidermal water loss
hydration measurement with corneometer probe
Time frame: through study completion, an average of 1 year
corneometer assessed stratum corneum hydration level
erythema measured with mexameter
Time frame: through study completion, an average of 1 year
mexameter assessed redness
1 secondary outcome
clinical score according to dermatologist scale
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: Yes. On request
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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.
josipa bukic study chair
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?
A study testing Emollient cream treatment and no treatment in people with Contact Dermatitis and Contact Dermatitis Irritant, 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 12 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 3 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josipa Bukic (00385917933752, jbukic@mefst.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEWL measurement with Khazaka probe (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2024.