Assessment of Niacinamide Cosmetic Product Efficacy in Mo... | NCT06331390

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

NCT06331390

Sponsor

University of Split, School of Medicine

Status

Unknown status

Last Update Posted

Mar 26, 2024Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Contact Dermatitis

Interventions

niacinamide cosmetic product
placebo

Countries

Croatia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2024Estimated

Primary Completion Date

Jun 2024Estimated

Completion Date

Jul 2024Estimated

First Submitted Date

Mar 19, 2024

First Submission Date that Met QC Criteria

Mar 19, 2024

First Posted Date

Mar 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2024

Last Update Posted Date

Mar 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dario Leskur, assistant professor, University of Split, School of MedicinePrincipal Investigator

Lead Sponsor

University of Split, School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervenition	Experimental	immortela cosmetic product	Other: niacinamide cosmetic product
placebo	Placebo Comparator	nothing	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
niacinamide cosmetic product	Other	immortella skincare product	intervenition

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
JOSIPA BUKIĆ	Contact	00385917933752		jbukic@mefst.hr

Overall Officials

Name	Affiliation	Role
JOSIPA BUKIĆ	USSM	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Split School of Medicine	Recruiting	Split			Croatia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003877	Dermatitis, Contact

Ancestor Terms

ID	Term
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous

Browse Leaves

Not provided

Browse Branches

Not provided