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

Primary Purpose

Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Coriander Seed Oil
Placebo
Sponsored by
Seppic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Complife Italia srl

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Coriander Seed Oil

Placebo

Arm Description

Dietary supplement - Coriander Seed Oil

Dietary supplement - Placebo

Outcomes

Primary Outcome Measures

Skin redness
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
Skin redness
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
Skin redness
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
Skin redness
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)

Secondary Outcome Measures

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).
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).
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).
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).
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.
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.
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)
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)
Self-assessment of product efficacy
Questionnaire (10 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)

Full Information

First Posted
September 7, 2023
Last Updated
September 7, 2023
Sponsor
Seppic
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1. Study Identification

Unique Protocol Identification Number
NCT06037291
Brief Title
Assessement of the Soothing Effect of a Food Supplement on Sensitive and Reactive Skin
Official Title
Assessment of the Soothing Effect of a Food Supplement on Sensitive and Reactive Skin. Double Blind Randomized Placebo-controlled Clinical Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seppic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coriander Seed Oil
Arm Type
Experimental
Arm Description
Dietary supplement - Coriander Seed Oil
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dietary supplement - Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Coriander Seed Oil
Intervention Description
The study foresees the intake of 1 capsule per day during 56 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The study foresees the intake of 1 capsule per day during 56 days
Primary Outcome Measure Information:
Title
Skin redness
Description
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
Time Frame
Baseline
Title
Skin redness
Description
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
Time Frame
14 days
Title
Skin redness
Description
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
Time Frame
28 days
Title
Skin redness
Description
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Skin stinging
Description
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).
Time Frame
Baseline
Title
Skin stinging
Description
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).
Time Frame
14 days
Title
Skin stinging
Description
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).
Time Frame
28 days
Title
Skin stinging
Description
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).
Time Frame
56 days
Title
Erythema index
Description
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.
Time Frame
Baseline
Title
Erythema index
Description
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.
Time Frame
56 days
Title
Skin TNF-alpha quantification (subgroup of 20 subjects)
Description
Quantification of TNF-alpha concentration by Enzyme-Linked Immunosorbent Assay on skin stripping performed 24h after UV exposure (non-irradiated and irradiated area)
Time Frame
Baseline
Title
Skin TNF-alpha quantification (subgroup of 20 subjects)
Description
Quantification of TNF-alpha concentration by Enzyme-Linked Immunosorbent Assay on skin stripping performed 24h after UV exposure (non-irradiated and irradiated area)
Time Frame
56 days
Title
Self-assessment of product efficacy
Description
Questionnaire (10 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)
Time Frame
56 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ileana De Ponti
Organizational Affiliation
Complife Italia S.r.l
Official's Role
Study Director
Facility Information:
Facility Name
Complife Italia srl
City
Milano
ZIP/Postal Code
20024
Country
Italy

12. IPD Sharing Statement

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

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