Glyceryl Eicosapentaenoate Based Topic Products As an Irritant-free Cream and Serum for Hydration of Sensitive Skin (COS-PBP-01)

SCF Pharma

Status: Enrolling

Conditions: Skin Dryness

Treatments: Other: Glyceryl Eicosapentaenoate Cream A; Other: Glyceryl Eicosapentaenoate Cream C; Other: Glyceryl Eicosapentaenoate serum; Other: Glyceryl Eicosapentaenoate Cream B

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06219213

COS-PBP-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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33 participants in 3 patient groups

Group A: Cream of formulation A

Experimental group

Description:

Daily application of glyceryl Eicosapentaenoate serum and glyceryl Eicosapentaenoate cream of formulation A on both targeted skin area. The skin areas must be clean and dry. Subjects may proceed with additional product applications if needed. However, for each additional application, both targeted areas must be treated with the Serum and the cream. Subjects must proceed with at least one application of products each day for 14 consecutive days.

Treatment:

Other: Glyceryl Eicosapentaenoate serum

Other: Glyceryl Eicosapentaenoate Cream A

Group B: Cream of formulation B

Experimental group

Description:

Daily application of glyceryl Eicosapentaenoate serum and glyceryl Eicosapentaenoate cream of formulation B on both targeted skin area. The skin areas must be clean and dry. Subjects may proceed with additional product applications if needed. However, for each additional application, both targeted areas must be treated with the Serum and the cream. Subjects must proceed with at least one application of products each day for 14 consecutive days.

Treatment:

Other: Glyceryl Eicosapentaenoate Cream B

Other: Glyceryl Eicosapentaenoate serum

Group C: Cream of formulation C

Experimental group

Description:

Daily application of glyceryl Eicosapentaenoate serum and glyceryl Eicosapentaenoate cream of formulation C on both targeted skin area. The skin areas must be clean and dry. Subjects may proceed with additional product applications if needed. However, for each additional application, both targeted areas must be treated with the Serum and the cream. Subjects must proceed with at least one application of products each day for 14 consecutive days.

Treatment:

Other: Glyceryl Eicosapentaenoate serum

Other: Glyceryl Eicosapentaenoate Cream C