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

NCT ID: NCT06189105

Last Updated: 2024-01-03

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-03

Study Completion Date

2024-06-01

Brief Summary

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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

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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.

Conditions

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Skin Hyperpigmentation Dry Skin; Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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experimental arm

Use of facial serum with

niacinamide, plant-based collagen and

peptides on randomized site on forehead

Group Type EXPERIMENTAL

miss alice face it you love me serum

Intervention Type OTHER

Facial serum with niacinamide, plant-based collagen and peptides will be applied by each participant to the treatment site according to randomization protocol every evening

placebo comparator

No treatment (usual

skincare rutine)

Group Type PLACEBO_COMPARATOR

No treatment (usual skincare rutine)

Intervention Type OTHER

No treatment (usual skincare rutine)

Interventions

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miss alice face it you love me serum

Facial serum with niacinamide, plant-based collagen and peptides will be applied by each participant to the treatment site according to randomization protocol every evening

Intervention Type OTHER

No treatment (usual skincare rutine)

No treatment (usual skincare rutine)

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Split, School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Dario Leskur

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dario Leskur

Role: STUDY_DIRECTOR

USSM

Locations

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University of Split School of Medicine

Split, , Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Josipa Bukic

Role: CONTACT

00385917933752

Facility Contacts

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Josipa Bukic

Role: primary

00385917933752

References

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Rusic D, Ivic M, Slugan A, Leskur D, Modun D, Durdov T, Vukovic D, Bukic J, Bozic J, Seselja Perisin A. Pilot Study on the Effects of a Cosmetic Serum Containing Niacinamide, Postbiotics and Peptides on Facial Skin in Healthy Participants: A Randomized Controlled Trial. Life (Basel). 2024 Dec 18;14(12):1677. doi: 10.3390/life14121677.

Reference Type DERIVED
PMID: 39768384 (View on PubMed)

Other Identifiers

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2181-198-03-04-23-032

Identifier Type: -

Identifier Source: org_study_id

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