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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06037291
• Other study ID #: IT0002762/21
• Status: Completed
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: September 2023
• Source: Seppic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers
• Hypersensitivity

Intervention

Dietary Supplement:
• Coriander Seed Oil
The study foresees the intake of 1 capsule per day during 56 days
• Placebo
The study foresees the intake of 1 capsule per day during 56 days

Locations

Country	Name	City	State
Italy	Complife Italia srl	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Seppic

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin redness	Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)	Baseline
Primary	Skin redness	Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)	14 days
Primary	Skin redness	Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)	28 days
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Self-assessment of product efficacy	Questionnaire (10 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)	56 days