Efficacy and Safety Assessment of Niacinamide Cosmetic Preparation: a Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: Skin Hyperpigmentation; Dry Skin; Eczema

• Registration Number: NCT06189105
• Lead Sponsor: University of Split, School of Medicine

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 Timeline

• Study Start: 2023-06-03
• Study First Submitted: 2023-09-13
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-18
• Last Update Submitted: 2023-12-18
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
skin oiliness assessment with sebumeter probe	through study completion, an average of 1 year	sebum level
Hydration assessment with corneometer probe	through study completion, an average of 1 year	stratum corneum hydration
TEWL assessment with Courage Khazaka probe	through study completion, an average of 1 year	Transepidermal water loss
pigmentation assessment with mexameter probe	through study completion, an average of 1 year	erythema and melanin

Secondary Outcome Measures

Name	Time	Method
subjective opinion of participants	through study completion, an average of 1 year	participants notes on skin rection

Trial Locations

Locations (1)

University of Split School of Medicine; 🇭🇷 Split, Croatia