Skin Barrier Disruption and RecoveryNCT07676253
Helichrysum Italicum Extract in Irritant Contact Dermatitis
A study testing Helichrysum italicum Extract Cream in people with Skin Barrier Disruption and Recovery, run by University of Split, School of Medicine at 1 site in Croatia.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of a topical cream containing Immortelle (Helichrysum italicum) extract in promoting skin barrier recovery and reducing signs of irritant contact dermatitis in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Barrier Disruption and Recovery
- What is being tested?
- Helichrysum italicum Extract Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jun 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- pregnancy or breastfeeding
- immunosuppression
- allergic or irritant reactions to the constituents of the cream
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
University of Split School of Medicine
Split, 21000
Josipa Bukić, +385917933753, jbukic@mefst.hr
About this study
Official title: Assessment of the Effect of Helichrysum Italicum Extract in Irritant Contact Dermatitis: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to evaluate the efficacy and safety of a topical cream containing Immortelle (Helichrysum italicum) extract in promoting skin barrier recovery and reducing signs of irritant contact dermatitis in healthy adult participants.
The main questions it aims to answer are:
Read more
- Does topical application of Helichrysum italicum extract improve skin barrier recovery following experimentally induced irritant contact dermatitis?
- Does the cream containing Helichrysum italicum extract reduce transepidermal water loss and erythema, and improve skin hydration compared to a standard moisturizing cream?
- Is the topical application of Helichrysum italicum extract safe and well tolerated?
Researchers will compare skin sites treated with a cream containing Helichrysum italicum extract, placebo-treated skin sites, and untreated skin sites to determine whether the addition of the extract provides additional benefits in skin barrier recovery.
Participants will:
- Undergo induction of irritant contact dermatitis using sodium lauryl sulfate (SLS) under occlusion.
- Apply a cream containing Helichrysum italicum extract to one designated skin site and a placebo cream to another designated skin site twice daily throughout the study period.
- Have an additional SLS-treated skin site left untreated to assess natural skin barrier recovery.
- Apply the cream containing Helichrysum italicum extract to a separate area of healthy, intact skin.
- Attend daily study visits for non-invasive assessments of skin barrier function, including transepidermal water loss, skin hydration, and erythema measurements.
- Conditions
- Skin Barrier Disruption and Recovery
- Being tested
- Helichrysum italicum Extract Cream, Placebo Cream
- Keywords
- Helichrysum italicum, Immortelle, Irritant contact dermatitis, Skin barrier recovery
- Medical subject headings
- Dermatitis, Irritant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helichrysum italicum Extract CreamOther
Topical emollient cream containing Helichrysum italicum extract
Placebo CreamOther
A moisturizing cream without Helichrysum italicum extract applied to the designated skin site.
| Study group | Role | What they receive |
|---|---|---|
| Helichrysum italicum Extract Cream | Experimental | Participants will receive a topical emollient cream containing Helichrysum italicum extract applied to an SLS-treated skin site. Receives: Other: Helichrysum italicum Extract Cream |
| Placebo Cream | Placebo comparator | Participants will receive the same emollient cream base without Helichrysum italicum extract applied to an SLS-treated skin site. Receives: Other: Placebo Cream |
| Untreated Control Site | No intervention | An SLS-treated skin site that will not receive any topical treatment and will serve as a control for natural skin barrier recovery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Transepidermal Water Loss (TEWL)
Skin barrier function will be assessed by measuring transepidermal water loss using a Tewameter TM 300 probe. Values will be expressed in g/m²/h
Measured: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
Change in Skin Hydration
Hydration of the stratum corneum will be assessed using a Corneometer CM 825 probe.
Measured: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
Change in Skin Erythema
Skin erythema will be assessed using a Mexameter MX 18 probe.
Measured: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jun 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Barrier Disruption and RecoveryStudies 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
- This is a randomized, placebo-controlled, intra-individual study in which each participant will receive all study conditions simultaneously on the forearms. Irritant contact dermatitis will be induced at designated skin sites using sodium lauryl sulfate (SLS) under occlusion. One SLS-treated site will be treated with a cream containing Helichrysum italicum extract, a second SLS-treated site will be treated with a placebo cream, and a third SLS-treated site will remain untreated to assess natural skin barrier recovery. In addition, the cream containing Helichrysum italicum extract will be applied to a separate area of healthy, intact skin to evaluate its effects and tolerability on non-irritated skin. The allocation of treatment sites will be determined according to the randomization protocol.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676253
- Sponsor's protocol ID
- 2181-198-03-04-26-0036
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Helichrysum Italicum Extract in Irritant Contact Dermatitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07676253
- Acronym / sponsor ID
- 2181-198-03-04-26-0036
- Conditions
- Skin Barrier Disruption and Recovery
- Keywords
- Helichrysum italicum, Immortelle, Irritant contact dermatitis, Skin barrier recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 30 Jun 2026 (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.
The goal of this clinical trial is to evaluate the efficacy and safety of a topical cream containing Immortelle (Helichrysum italicum) extract in promoting skin barrier recovery and reducing signs of irritant contact dermatitis in healthy adult participants.
The main questions it aims to answer are:
- Does topical application of Helichrysum italicum extract improve skin barrier recovery following experimentally induced irritant contact dermatitis?
- Does the cream containing Helichrysum italicum extract reduce transepidermal water loss and erythema, and improve skin hydration compared to a standard moisturizing cream?
- Is the topical application of Helichrysum italicum extract safe and well tolerated?
Researchers will compare skin sites treated with a cream containing Helichrysum italicum extract, placebo-treated skin sites, and untreated skin sites to determine whether the addition of the extract provides additional benefits in skin barrier recovery.
Participants will:
- Undergo induction of irritant contact dermatitis using sodium lauryl sulfate (SLS) under occlusion.
- Apply a cream containing Helichrysum italicum extract to one designated skin site and a placebo cream to another designated skin site twice daily throughout the study period.
- Have an additional SLS-treated skin site left untreated to assess natural skin barrier recovery.
- Apply the cream containing Helichrysum italicum extract to a separate area of healthy, intact skin.
- Attend daily study visits for non-invasive assessments of skin barrier function, including transepidermal water loss, skin hydration, and erythema measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a randomized, placebo-controlled, intra-individual study in which each participant will receive all study conditions simultaneously on the forearms. Irritant contact dermatitis will be induced at designated skin sites using sodium lauryl sulfate (SLS) under occlusion. One SLS-treated site will be treated with a cream containing Helichrysum italicum extract, a second SLS-treated site will be treated with a placebo cream, and a third SLS-treated site will remain untreated to assess natural skin barrier recovery. In addition, the cream containing Helichrysum italicum extract will be applied to a separate area of healthy, intact skin to evaluate its effects and tolerability on non-irritated skin. The allocation of treatment sites will be determined according to the randomization protocol.
| Arm | Type | Receives |
|---|---|---|
| Helichrysum italicum Extract Cream | Experimental | Other: Helichrysum italicum Extract CreamParticipants will receive a topical emollient cream containing Helichrysum italicum extract applied to an SLS-treated skin site. |
| Placebo Cream | Placebo comparator | Other: Placebo CreamParticipants will receive the same emollient cream base without Helichrysum italicum extract applied to an SLS-treated skin site. |
| Untreated Control Site | No intervention | –An SLS-treated skin site that will not receive any topical treatment and will serve as a control for natural skin barrier recovery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers who gave written informed consent
Key exclusion criteria (6 listed)
- skin disease
- skin damage on measurement sites
- use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
- pregnancy or breastfeeding
- immunosuppression
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 |
|---|---|---|
| Helichrysum italicum Extract CreamTopical emollient cream containing Helichrysum italicum extract | Other | Helichrysum italicum Extract Cream |
| Placebo CreamA moisturizing cream without Helichrysum italicum extract applied to the designated skin site. | Other | Placebo Cream |
Primary outcome
Change in Transepidermal Water Loss (TEWL)
Time frame: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
Skin barrier function will be assessed by measuring transepidermal water loss using a Tewameter TM 300 probe. Values will be expressed in g/m²/h
Change in Skin Hydration
Time frame: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
Hydration of the stratum corneum will be assessed using a Corneometer CM 825 probe.
Change in Skin Erythema
Time frame: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
Skin erythema will be assessed using a Mexameter MX 18 probe.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Skin Barrier Disruption and Recovery
Recruiting
Evaluation of a Peptide Cream on the Forearm Skin Recovery of Healthy Volunteers
Skin Barrier Disruption and Recovery
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helichrysum italicum Extract Cream in people with Skin Barrier Disruption and Recovery, 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 6 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josipa Bukić (+385917933753, jbukic@mefst.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Transepidermal Water Loss (TEWL) (time frame: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).). 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 17 Jul 2026.