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Clinical Trials/NCT06189105
NCT06189105RecruitingNot Applicable

Testing the Efficacy and Safety of Niacinamide Cosmetic Preparation: A Randomised, Controlled Trial

University of Split, School of Medicine1 site in 1 country25 target enrollmentStarted: June 3, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
25
Locations
1
Primary Endpoint
skin oiliness assessment with sebumeter probe

Study Overview

Brief Summary

Niacinamide in lower concentrations has been recognized as a cosmetic ingredient with hydrating properties. Therefore, aim was to test the efficacy and safety of niacinamide cosmetic preparation in A Randomized, Controlled Trial.

Detailed Description

Skin hydration (as use of hydrating cosmetic ingredients) is one of the most interventions for healthy skin and skin barrier function. Therefore, cosmetic ingredients used for this purpose should be examined for their efficacy.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • healthy volunteers who gave written informed consent

Exclusion Criteria

  • skin disease, skin damage on measurement sites, use of corticosteroids and immunomodulators a month prior to the inclusion and during the trial, non-adherence to the trial protocol, exposure to artificial UV radiation, pregnancy and lactation

Outcomes

Primary Outcomes

skin oiliness assessment with sebumeter probe

Time Frame: through study completion, an average of 1 year

sebum level

Hydration assessment with corneometer probe

Time Frame: through study completion, an average of 1 year

stratum corneum hydration

TEWL assessment with Courage Khazaka probe

Time Frame: through study completion, an average of 1 year

Transepidermal water loss

pigmentation assessment with mexameter probe

Time Frame: through study completion, an average of 1 year

erythema and melanin

Secondary Outcomes

  • subjective opinion of participants(through study completion, an average of 1 year)

Investigators

Sponsor
University of Split, School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dario Leskur

assistant professor

University of Split, School of Medicine

Study Sites (1)

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