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

January 22, 2024 updated by: SCF Pharma

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Rimouski, Quebec, Canada, G0K 1P0
        • Recruiting
        • Institut de recherche clinique du littoral (IRCL)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Cream of formulation A
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
Daily application of serum on both targeted skin areas for 14 consecutive days. Serum must be applied before the Cream on clean skin.
Other: Glyceryl Eicosapentaenoate Cream A
Daily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum.
Experimental: Group B: Cream of formulation B
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
Daily application of serum on both targeted skin areas for 14 consecutive days. Serum must be applied before the Cream on clean skin.
Other: Glyceryl Eicosapentaenoate Cream B
Daily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum.
Experimental: Group C: Cream of formulation C
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
Daily application of serum on both targeted skin areas for 14 consecutive days. Serum must be applied before the Cream on clean skin.
Other: Glyceryl Eicosapentaenoate Cream C
Daily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of Hydration
Time Frame: 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.
2 weeks
Measure of skin redness
Time Frame: 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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Control of skin appearance and adverse events
Time Frame: 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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCF Pharma

Collaborators

Institut de recherche clinique du littoral (IRCL)

Investigators

  • Principal Investigator: Samuel Fortin, Ph.D, SCF Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2023

Primary Completion (Estimated)

July 24, 2024

Study Completion (Estimated)

August 7, 2024

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • COS-PBP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The results of this research are the private property of SCF Pharma. If you are interested in the results of this study, you can contact Dr Samuel Fortin for a summary starting in summer 2025.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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