Assessment of Niacinamide Cosmetic Product Efficacy in Model of Irritant Contact Dermatitis

March 19, 2024 updated by: Dario Leskur, University of Split, School of Medicine

Randomized Controlled Trial of Niacinamide Cosmetic Product Efficacy in Model of Irritant Contact Dermatitis

Testing the effectiveness and safety of cosmetics with niacinamide in irritant contact dermatitis: A Randomised, Controlled Trial will be conducted at USSM. Healthy volunteers will be included (at least 25) and test sites are forearms. Sodium lauryl sulphate will be used to induce contact dermatitis and participants will be measured for 7 days

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The efficacy of niacinamide cosmetic product on contact dermatitis will be evaluated using Courage Khazaka device and probes for hydration, redness and transepidermal water loss

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • young, 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervenition
immortela cosmetic product
Other: niacinamide cosmetic product
immortella skincare product
Placebo Comparator: placebo
nothing
Other: placebo
nothing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tewameter
Time Frame: day 1- day 7
measurement of transepidermal water loss on skin, objective and non invasive
day 1- day 7

Collaborators and Investigators

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

Sponsor

University of Split, School of Medicine

Investigators

  • Principal Investigator: JOSIPA BUKIĆ, 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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2181-198-03-04-24-0008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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