NCT06331390

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 19, 2024

Last Update Submit

March 19, 2024

Conditions

Contact Dermatitis

Outcome Measures

Primary Outcomes (1)

  • tewameter

    measurement of transepidermal water loss on skin, objective and non invasive

    day 1- day 7

Study Arms (2)

intervenition

EXPERIMENTAL

immortela cosmetic product

Other: niacinamide cosmetic product

placebo

PLACEBO COMPARATOR

nothing

Other: placebo

Interventions

niacinamide cosmetic productOTHER

immortella skincare product

intervenition
placeboOTHER

nothing

placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • young, healthy volunteers who gave written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Split School of Medicine

Split, Croatia

RECRUITING

MeSH Terms

Conditions

Dermatitis, Contact

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • JOSIPA BUKIĆ

    USSM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JOSIPA BUKIĆ

CONTACT

00385917933752jbukic@mefst.hr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 26, 2024

Study Start

April 1, 2024

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

March 26, 2024

Record last verified: 2024-03

Locations

CR(1)