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

NCT06037291 | Completed

• 1 other identifier: IT0002762/21
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• Skin redness

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

  Baseline

• Skin redness

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

  14 days

• Skin redness

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

  28 days

• 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 Outcomes (9)

• Skin stinging

  Baseline

• Skin stinging

  14 days

• Skin stinging

  28 days

• Skin stinging

  56 days

• Erythema index

  Baseline

Study Arms (2)

Coriander Seed Oil

EXPERIMENTAL

Dietary supplement - Coriander Seed Oil

Dietary Supplement: Coriander Seed Oil

Placebo

PLACEBO COMPARATOR

Dietary supplement - Placebo

Dietary Supplement: Placebo

Interventions

Coriander Seed Oil DIETARY_SUPPLEMENT

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

Coriander Seed Oil

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seppic: lead

Study Sites (1)

Complife Italia srl

Milan, 20024, Italy

Location

Study Officials

• Ileana De Ponti

  Complife Italia S.r.l

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: October 15, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

IT (1)