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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: Coriander Seed Oil; Dietary Supplement: Placebo

• Registration Number: NCT06037291
• Lead Sponsor: Seppic

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.

Study Timeline

• Study Start: 2021-10-15
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2023-09
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-07
• Last Update Submitted: 2023-09-07
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coriander Seed Oil	Coriander Seed Oil	Dietary supplement - Coriander Seed Oil
Placebo	Placebo	Dietary supplement - Placebo

Primary Outcome Measures

Name	Time	Method
Skin redness	56 days	Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a\* parameter)

Secondary Outcome Measures

Name	Time	Method
Self-assessment of product efficacy	56 days	Questionnaire (10 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)
Skin stinging	56 days	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	56 days	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)	56 days	Quantification of TNF-alpha concentration by Enzyme-Linked Immunosorbent Assay on skin stripping performed 24h after UV exposure (non-irradiated and irradiated area)

Trial Locations

Locations (1)

Complife Italia srl; 🇮🇹 Milano, Italy