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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06331390
Other study ID # 2181-198-03-04-24-0008
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date July 2024

Study information

Verified date March 2024
Source University of Split, School of Medicine
Contact JOSIPA BUKIC
Phone 00385917933752
Email jbukic@mefst.hr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date July 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
niacinamide cosmetic product
immortella skincare product
placebo
nothing

Locations

Country Name City State
Croatia University of Split School of Medicine Split

Sponsors (1)

Lead Sponsor Collaborator
University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Primary tewameter measurement of transepidermal water loss on skin, objective and non invasive day 1- day 7
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