Glyceryl Eicosapentaenoate Based Topic Products As an Irritant-free Cream and Serum for Hydration of Sensitive Skin

Not Applicable

Recruiting

• Conditions: Skin Dryness

• Registration Number: NCT06219213
• Lead Sponsor: SCF Pharma

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.

Study Timeline

• Study Start: 2023-07-25
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-07-24
• Study Completion: 2025-08-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Measure of Hydration	2 weeks	For each subject in every group, skin hydration will be measured by corneometry at baseline (visit 1/ pre-treatment) and after one (1) week of treatment (visit 2) and two (2) weeks of treatment (visit 3). Only the targeted treated areas will be used for the measure of hydration.
Measure of skin redness	2 weeks	For each subject in every group, skin redness will be measured by mexametry at baseline (visit 1/ pre-treatment) and after one (1) week of treatment (visit 2) and two (2) weeks of treatment (visit 3). Only the targeted treated areas will be used for the measure of redness.

Secondary Outcome Measures

Name	Time	Method
Control of skin appearance and adverse events	2 weeks	At each study visit, every subjet will be questioned for any adverse effect observed on targeted (treated) areas. Photos of both targeted areas will also be taken for every subject at each study visit. No measure or quantification are planned for these photos. They will remain in the files as documentation and will only be used if an adverse event need investigation.

Trial Locations

Locations (1)

Institut de recherche clinique du littoral (IRCL); 🇨🇦 Rimouski, Quebec, Canada