Glyceryl Eicosapentaenoate Based Topic Products As an Irritant-free Cream and Serum for Hydration of Sensitive Skin
NCT ID: NCT06219213
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
33 participants
INTERVENTIONAL
2023-07-25
2025-08-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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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.
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.
Glyceryl Eicosapentaenoate Cream A
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
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.
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.
Glyceryl Eicosapentaenoate Cream B
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
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.
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.
Glyceryl Eicosapentaenoate Cream C
Daily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum.
Interventions
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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.
Glyceryl Eicosapentaenoate Cream A
Daily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum.
Glyceryl Eicosapentaenoate Cream B
Daily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum.
Glyceryl Eicosapentaenoate Cream C
Daily application of cream on both targeted skin areas for 14 consecutive days. Cream must be applied after the serum.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Institut de recherche clinique du littoral (IRCL)
UNKNOWN
SCF Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Samuel Fortin, Ph.D
Role: PRINCIPAL_INVESTIGATOR
SCF Pharma
Locations
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Institut de recherche clinique du littoral (IRCL)
Rimouski, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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COS-PBP-01
Identifier Type: -
Identifier Source: org_study_id