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

December 18, 2023 updated by: Dario Leskur, University of Split, School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Croatia
      • Split, Croatia
        • Recruiting
        • University of Split School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental arm

Use of facial serum with

niacinamide, plant-based collagen and

peptides on randomized site on forehead
Other: 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
Placebo Comparator: placebo comparator

No treatment (usual

skincare rutine)
Other: No treatment (usual skincare rutine)
No treatment (usual skincare rutine)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective opinion of participants
Time Frame: through study completion, an average of 1 year
participants notes on skin rection
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Split, School of Medicine

Investigators

  • Study Director: Dario Leskur, USSM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

December 18, 2023

First Posted (Estimated)

January 3, 2024

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2181-198-03-04-23-032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

upon request

IPD Sharing Time Frame

upon request

IPD Sharing Access Criteria

upon request

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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