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There was an important change in the product formulation
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Fortin, Ph.D | SCF Pharma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de recherche clinique du littoral (IRCL) | Rimouski | Quebec | G0K 1P0 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29229630 | Background | 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. | |
| 35523995 | 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. |
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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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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.
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| 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. |
|
| 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. |
|
| 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. |
|
| 2 weeks |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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