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The study is aimed to assess the soothing effect of a food supplement composed of Coriander Seed Oil (CSO) in terms of reducing skin redness and skin discomfort (stinging feeling) on sensitive and reactive skin.
A double blind, parallel groups, placebo-controlled study is carried out on 80 female subjects aged between 18 and 65 years old with sensitive and reactive skin.
The study foresees 56 days of products intake. Evaluations of the parameters under study are performed at baseline, after 14, 28 and 56 days of products consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coriander Seed Oil | Experimental | Dietary supplement - Coriander Seed Oil |
|
| Placebo | Placebo Comparator | Dietary supplement - Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coriander Seed Oil | Dietary Supplement | The study foresees the intake of 1 capsule per day during 56 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin redness | Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter) | Baseline |
| Skin redness | Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter) | 14 days |
| Skin redness | Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter) | 28 days |
| Skin redness | Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter) | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Skin stinging | Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction). | Baseline |
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Inclusion criteria :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ileana De Ponti | Complife Italia Srl | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complife Italia srl | Milan | 20024 | Italy |
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| Placebo | Dietary Supplement | The study foresees the intake of 1 capsule per day during 56 days |
|
| Skin stinging | Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction). | 14 days |
| Skin stinging | Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction). | 28 days |
| Skin stinging | Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction). | 56 days |
| Erythema index | Induction of skin redness by UVA+UVB exposure followed by the evaluation of the erythema index (skin haemoglobin content) by Mexameter® 24h after UV exposure. | Baseline |
| Erythema index | Induction of skin redness by UVA+UVB exposure followed by the evaluation of the erythema index (skin haemoglobin content) by Mexameter® 24h after UV exposure. | 56 days |
| Skin TNF-alpha quantification (subgroup of 20 subjects) | Quantification of TNF-alpha concentration by Enzyme-Linked Immunosorbent Assay on skin stripping performed 24h after UV exposure (non-irradiated and irradiated area) | Baseline |
| Skin TNF-alpha quantification (subgroup of 20 subjects) | Quantification of TNF-alpha concentration by Enzyme-Linked Immunosorbent Assay on skin stripping performed 24h after UV exposure (non-irradiated and irradiated area) | 56 days |
| Self-assessment of product efficacy | Questionnaire (10 questions with 4 possible answers : completely agree / agree / disagree / completely disagree) | 56 days |