Efficacy and Safety Assessment of Niacinamide Cosmetic Preparation: a Randomized Controlled Trial
Testing the Efficacy and Safety of Niacinamide Cosmetic Preparation: A Randomised, Controlled Trial
1 other identifier
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2023
CompletedFirst Submitted
Initial submission to the registry
September 13, 2023
CompletedFirst Posted
Study publicly available on registry
January 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedJanuary 3, 2024
December 1, 2023
12 months
September 13, 2023
December 18, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
TEWL assessment with Courage Khazaka probe
Transepidermal water loss
through study completion, an average of 1 year
Hydration assessment with corneometer probe
stratum corneum hydration
through study completion, an average of 1 year
pigmentation assessment with mexameter probe
erythema and melanin
through study completion, an average of 1 year
skin oiliness assessment with sebumeter probe
sebum level
through study completion, an average of 1 year
Secondary Outcomes (1)
subjective opinion of participants
through study completion, an average of 1 year
Study Arms (2)
experimental arm
EXPERIMENTALUse of facial serum with niacinamide, plant-based collagen and peptides on randomized site on forehead
placebo comparator
PLACEBO COMPARATORNo treatment (usual skincare rutine)
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
Related Publications (1)
Rusic D, Ivic M, Slugan A, Leskur D, Modun D, Durdov T, Vukovic D, Bukic J, Bozic J, Seselja Perisin A. Pilot Study on the Effects of a Cosmetic Serum Containing Niacinamide, Postbiotics and Peptides on Facial Skin in Healthy Participants: A Randomized Controlled Trial. Life (Basel). 2024 Dec 18;14(12):1677. doi: 10.3390/life14121677.
PMID: 39768384DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dario Leskur
USSM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
September 13, 2023
First Posted
January 3, 2024
Study Start
June 3, 2023
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
January 3, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- upon request
- Access Criteria
- upon request
upon request