Clinical trial NCT06219213: Glyceryl Eicosapentaenoate Based Topic Products As an Irritant-free Cream and Serum for Hydration of Sensitive Skin
Official title: Impact of a Daily Application of Serum and Cream Containing Glyceryl Eicosapentaenoate and Short-chain Fatty Acids on Skin Hydration: Exploratory Study (COS-PBP-01)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Dryness
Keywords: Skin hydration
Skin inflammation
Eczema
Lead sponsor: SCF Pharma
Sponsor class: INDUSTRY
Collaborators: name: Institut de recherche clinique du littoral (IRCL)
First posted: 2024-01-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The first eleven (11) subjects enrolled will be assigned to group A. Group B will follow with the eleven next subjets (subjects 12 to 22) and group C will complete the study with subjects 23 to 33. The pre-treatment state of subjects will serve as control for the effects observed following treatment.
Primary purpose: BASIC_SCIENCE

Brief summary: This exploratory study aims to verify the hydrating potential as well as the possible irritant effects of a 14-day hydrating treatment consisting of daily application of serum and cream to the skin of two dry targeted areas. Thirty-three (33) subjects will be enrolled in this study and will be divided into three different treatment groups of 11 subjects each. Apart from the formulation of the cream which varies between the three groups, the subjects will receive the same serum and adhere to the same study plan for fourteen days. Each subject's baseline condition before treatment will serve as a control for effects observed after treatment on targeted areas.

Detailed description: The aim of this study is to verify the moisturizing potential of three different creams containing glyceryl eicosapentaenoates when used as a moisturizing treatment combined with a glyceryl eicosapentaenoate serum. Thirty-three (33) subjects will be enrolled in this study and will be divided into three different treatment groups of 11 subjects each. Before the first treatment, research staff must identify two areas of skin for each subject, ideally with different appearances. The assigned treatment will be applied to the targeted areas which will be used to measure hydration and redness. Apart from the formulation of the cream which varies between the three groups, subjects will receive the same serum and adhere to the same study plan. Subjects will be asked to apply the serum and cream to the targeted clean areas at least once a day, every day, for a period of fourteen (14) days. The baseline state before treatment will serve as a control for the effects observed after treatment on the targeted areas. The targeted areas will be used to measure hydration and redness:

1. Measure the skin hydration rate in the two selected areas by corneometry at the start of the study (pre-treatment), as well as after one (1) and two (2) weeks of treatment (at visits 2 and 3).
2. Measure the redness of the skin in the two selected areas by mexametry at the start of the study (pre-treatment), as well as after one (1) and two (2) weeks of treatment (at visits 2 and 3).

This study will help to evaluate and refine the treatment plan (frequency of application, duration of treatment, etc.) for future research projects with the same products. It will also assess the safety of the different formulations of the treatment.

Eligibility criteria: Inclusion Criteria:

* Participant aged between 18 and 65 years old.
* Participant who reports having dry skin.
* Available for the entire duration of the study and willing to participate based on the information provided in the informed consent form duly read and signed by the latter.
* Participant not presenting intellectual problems likely to limit the validity of consent to participate in the study and compliance with protocol requirements, having the ability to cooperate adequately, understand and observe the instructions of research staff.

Exclusion Criteria:

* Participant with a skin disease diagnosed by their treating physician and who requires drug treatment.

Primary outcomes:
measure: Measure of Hydration
timeFrame: 2 weeks
measure: Measure of skin redness
timeFrame: 2 weeks
Secondary outcomes:
measure: Control of skin appearance and adverse events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Rimouski
country: Canada
facility: Institut de recherche clinique du littoral (IRCL)
state: Quebec
Study officials:
affiliation: SCF Pharma
name: Samuel Fortin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Purnamawati S, Indrastuti N, Danarti R, Saefudin T. The Role of Moisturizers in Addressing Various Kinds of Dermatitis: A Review. Clin Med Res. 2017 Dec;15(3-4):75-87. doi: 10.3121/cmr.2017.1363. Epub 2017 Dec 11.
citation: Hsu CK, Cheng NY, Yang CC, Yen YY, Tseng SH. Investigating the clinical implication of corneometer and mexameter readings towards objective, efficient evaluation of psoriasis vulgaris severity. Sci Rep. 2022 May 6;12(1):7469. doi: 10.1038/s41598-022-11573-2.