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

September 7, 2023 updated by: Seppic

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20024
        • Complife Italia Srl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Dietary supplement - Placebo
Dietary supplement: Placebo
The study foresees the intake of 1 capsule per day during 56 days
Experimental: Coriander Seed Oil
Dietary supplement - Coriander Seed Oil
Dietary supplement: Coriander Seed Oil
The study foresees the intake of 1 capsule per day during 56 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Skin redness
Time Frame: Baseline
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
Baseline
Skin redness
Time Frame: 14 days
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
14 days
Skin redness
Time Frame: 28 days
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
28 days
Skin redness
Time Frame: 56 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Skin stinging
Time Frame: Baseline
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
Time Frame: 14 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).
14 days
Skin stinging
Time Frame: 28 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).
28 days
Skin stinging
Time Frame: 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).
56 days
Erythema index
Time Frame: Baseline
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
Time Frame: 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.
56 days
Skin TNF-alpha quantification (subgroup of 20 subjects)
Time Frame: Baseline
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)
Time Frame: 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)
56 days
Self-assessment of product efficacy
Time Frame: 56 days
Questionnaire (10 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seppic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ileana De Ponti, Complife Italia S.r.l

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IT0002762/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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