Assessement of the Soothing Effect of a Food Supplement on Sensitive and Reactive Skin

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of the Soothing Effect of a Food Supplement on Sensitive and Reactive Skin. Double Blind Randomized Placebo-controlled Clinical Study.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Coriander Seed Oil
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Good general health Caucasian ethnicity Female sex Phototype I to IV Sensitive and reactive skin (showing positive answer from 3-moderate to 4-strong to stinging test performed with a 10% lactic acid solution) Age between 18 and 65 years old (subject with 18 and 65 years old can be included) Subjects who have not been recently involved in any other similar study (evaluation is performed case by case by the experimenter but at least 1 month must be elapsed between a previous study on food supplement) Willingness to use during all the study period only the products to be tested Willingness not to use similar products that could interfere with the product to be tested Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, diet etc.) Subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial Subject aware of the study procedures and having signed an informed consent form Subjects who accept not to expose in intensive way to UV rays during the whole study duration Subjects who have not involved in any sun test (for SPF evaluation) or tests that provide skin irradiation since less than two months Exclusion Criteria: Subject does not meet the inclusion criteria, Pregnant/breastfeeding female or who have planned a pregnancy during the study period Subjects under systemically pharmacological treatment Subjects under locally pharmacological treatment on the skin area monitored during the test Subjects with congenital or acquired immunodeficiency Subjects under treatment with food supplements which could interfere with the functionality of the product under study Subjects which show skin alterations on the monitored area which could interfere with the functionality of the product under study Subjects considered as not adequate to participate to the study by the investigator Subjects with known or suspected sensitization to one or more test formulation ingredients Adult protected by law (under control or hospitalized in public or private institutions for reasons other than research, or incarcerated) Subjects not able to communicate or cooperate with the investigator for problems related to language, mental retardation or impaired brain function

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coriander Seed Oil<br>Dietary supplement - Coriander Seed Oil | Dietary Supplement: Coriander Seed Oil<br>* The study foresees the intake of 1 capsule per day during 56 days<br>|
| Placebo Comparator: Placebo<br>Dietary supplement - Placebo | Dietary Supplement: Placebo<br>* The study foresees the intake of 1 capsule per day during 56 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |