Skin DrynessCOS-PBP-01NCT06219213
Glyceryl Eicosapentaenoate Based Topic Products as an Irritant-free Cream and Serum for Hydration of Sensitive Skin
A study testing Glyceryl Eicosapentaenoate serum, Glyceryl Eicosapentaenoate Cream A and Glyceryl Eicosapentaenoate Cream B in people with Skin Dryness, run by SCF Pharma at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Dryness
- What is being tested?
- Glyceryl Eicosapentaenoate serum, Glyceryl Eicosapentaenoate Cream A and Glyceryl Eicosapentaenoate Cream B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jul 2023to 5 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participant with a skin disease diagnosed by their treating physician and who requires drug treatment.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de recherche clinique du littoral (IRCL)
Rimouski, Quebec, G0K 1P0
About this study
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)
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.
Read the 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:
- 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).
- 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.
- Conditions
- Skin Dryness
- Being tested
- Glyceryl Eicosapentaenoate serum, Glyceryl Eicosapentaenoate Cream A, Glyceryl Eicosapentaenoate Cream B, Glyceryl Eicosapentaenoate Cream C
- Keywords
- Skin hydration, Skin inflammation, Eczema
- Medical subject headings
- Dermatitis, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glyceryl Eicosapentaenoate serumOther
Daily application of serum on both targeted skin areas for 14 consecutive days. Serum must be applied before the Cream on clean skin.
Glyceryl Eicosapentaenoate Cream AOther
Daily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum.
Glyceryl Eicosapentaenoate Cream BOther
Daily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum.
Glyceryl Eicosapentaenoate Cream COther
Daily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Glyceryl Eicosapentaenoate serum; Other: Glyceryl Eicosapentaenoate Cream C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks
Secondary outcomes (1)
Control of skin appearance and adverse events
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start25 Jul 2023
- Primary completion5 Nov 2025
- Study completion5 Nov 2025
Why it stopped: There was an important change in the product formulation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin DrynessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCF Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Fortin, Ph.D, Principal investigator, SCF Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219213
- Sponsor's protocol ID
- COS-PBP-01
- Acronym
- COS-PBP-01
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 29229630Hsu 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.
PubMed 35523995
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06219213
- Acronym / sponsor ID
- COS-PBP-01 / COS-PBP-01
- Conditions
- Skin Dryness
- Keywords
- Skin hydration, Skin inflammation, Eczema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There was an important change in the product formulation
- Enrolment
- 21 participants (actual)
- Lead sponsor
- SCF PharmaIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A: Cream of formulation A | Experimental | Other: Glyceryl Eicosapentaenoate serum, Other: Glyceryl Eicosapentaenoate Cream ADaily 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. |
| Group B: Cream of formulation B | Experimental | Other: Glyceryl Eicosapentaenoate serum, Other: Glyceryl Eicosapentaenoate Cream BDaily 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. |
| Group C: Cream of formulation C | Experimental | Other: Glyceryl Eicosapentaenoate serum, Other: Glyceryl Eicosapentaenoate Cream CDaily 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Participant with a skin disease diagnosed by their treating physician and who requires drug treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glyceryl Eicosapentaenoate serumDaily application of serum on both targeted skin areas for 14 consecutive days. Serum must be applied before the Cream on clean skin. | Other | Group A: Cream of formulation A, Group B: Cream of formulation B, Group C: Cream of formulation C |
| Glyceryl Eicosapentaenoate Cream ADaily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum. | Other | Group A: Cream of formulation A |
| Glyceryl Eicosapentaenoate Cream BDaily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum. | Other | Group B: Cream of formulation B |
| Glyceryl Eicosapentaenoate Cream CDaily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum. | Other | Group C: Cream of formulation C |
Primary outcome
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.
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.
1 secondary outcome
Control of skin appearance and adverse events
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: There was an important change in the product formulation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 29229630Purnamawati 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.
- Background: PubMed 35523995Hsu 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Fortin, Ph.D principal investigator
SCF Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glyceryl Eicosapentaenoate serum, Glyceryl Eicosapentaenoate Cream A and Glyceryl Eicosapentaenoate Cream B in people with Skin Dryness, run by SCF Pharma at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: There was an important change in the product formulation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Hydration (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06219213, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.