Clinical trial NCT06037291: Assessement of the Soothing Effect of a Food Supplement on Sensitive and Reactive Skin
Official title: Assessment of the Soothing Effect of a Food Supplement on Sensitive and Reactive Skin. Double Blind Randomized Placebo-controlled Clinical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Seppic
Sponsor class: INDUSTRY
First posted: 2023-09-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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

Primary outcomes:
measure: Skin redness
timeFrame: Baseline
measure: Skin redness
timeFrame: 14 days
measure: Skin redness
timeFrame: 28 days
measure: Skin redness
timeFrame: 56 days
Secondary outcomes:
measure: Skin stinging
timeFrame: Baseline
measure: Skin stinging
timeFrame: 14 days
measure: Skin stinging
timeFrame: 28 days
measure: Skin stinging
timeFrame: 56 days
measure: Erythema index
timeFrame: Baseline
measure: Erythema index
timeFrame: 56 days
measure: Skin TNF-alpha quantification (subgroup of 20 subjects)
timeFrame: Baseline
measure: Skin TNF-alpha quantification (subgroup of 20 subjects)
timeFrame: 56 days
measure: Self-assessment of product efficacy
timeFrame: 56 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Complife Italia srl
Study officials:
affiliation: Complife Italia S.r.l
name: Ileana De Ponti
role: STUDY_DIRECTOR
References: