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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Helichrysum italicum Extract Cream | Experimental | Participants will receive a topical emollient cream containing Helichrysum italicum extract applied to an SLS-treated skin site. |
|
| Placebo Cream | Placebo Comparator | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helichrysum italicum Extract Cream | Other | Topical emollient cream containing Helichrysum italicum extract |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josipa Bukić | Contact | +385917933753 | jbukic@mefst.hr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Split School of Medicine | Recruiting | Split | 21000 | Croatia |
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| ID | Term |
|---|---|
| D017453 | Dermatitis, Irritant |
| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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.
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| Placebo Cream | Other | A moisturizing cream without Helichrysum italicum extract applied to the designated skin site. |
|
| D017443 |
| Skin Diseases, Eczematous |