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

NCT ID: NCT06037291

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2022-01-31

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Coriander Seed Oil

Dietary supplement - Coriander Seed Oil

Group Type: EXPERIMENTAL

Coriander Seed Oil

Intervention Type: DIETARY_SUPPLEMENT

The study foresees the intake of 1 capsule per day during 56 days

Placebo

Dietary supplement - Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The study foresees the intake of 1 capsule per day during 56 days

Interventions

Coriander Seed Oil

The study foresees the intake of 1 capsule per day during 56 days

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The study foresees the intake of 1 capsule per day during 56 days

Intervention Type: DIETARY_SUPPLEMENT

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seppic

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ileana De Ponti

Role: STUDY_DIRECTOR

Complife Italia S.r.l

Locations

Complife Italia srl

Milan, , Italy

Countries

Italy

Other Identifiers

IT0002762/21

Identifier Type: -

Identifier Source: org_study_id