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

NCT06219213 | Terminated

• 1 other identifier: COS-PBP-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Dryness

Keywords

Skin hydration; Skin inflammation; Eczema

Outcome Measures

Primary Outcomes (2)

• Measure of Hydration

  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.

  2 weeks

• Measure of skin redness

  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.

  2 weeks

Secondary Outcomes (1)

• Control of skin appearance and adverse events

  2 weeks

Study Arms (3)

Group A: Cream of formulation A

EXPERIMENTAL

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.

Other: Glyceryl Eicosapentaenoate serum; Other: Glyceryl Eicosapentaenoate Cream A

Group B: Cream of formulation B

EXPERIMENTAL

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.

Other: Glyceryl Eicosapentaenoate serum; Other: Glyceryl Eicosapentaenoate Cream B

Group C: Cream of formulation C

EXPERIMENTAL

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.

Other: Glyceryl Eicosapentaenoate serum; Other: Glyceryl Eicosapentaenoate Cream C

Interventions

Glyceryl Eicosapentaenoate serum OTHER

Daily application of serum on both targeted skin areas for 14 consecutive days. Serum must be applied before the Cream on clean skin.

Group A: Cream of formulation A; Group B: Cream of formulation B; Group C: Cream of formulation C

Glyceryl Eicosapentaenoate Cream B OTHER

Daily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum.

Group B: Cream of formulation B

Glyceryl Eicosapentaenoate Cream C OTHER

Daily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum.

Group C: Cream of formulation C

Glyceryl Eicosapentaenoate Cream A OTHER

Daily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum.

Group A: Cream of formulation A

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• SCF Pharma: lead

Study Sites (1)

Institut de recherche clinique du littoral (IRCL)

Rimouski, Quebec, G0K 1P0, Canada

Location

Related Publications (2)

• 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.

  PMID: 29229630 BACKGROUND

• 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.

  PMID: 35523995 BACKGROUND

MeSH Terms

Conditions

Dermatitis; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Samuel Fortin, Ph.D

  SCF Pharma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: July 25, 2023
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)