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RecruitingNCT06189105Updated Jan 3, 2024

Efficacy and Safety Assessment of Niacinamide Cosmetic Preparation: a Randomized Controlled Trial

An interventional study of miss alice face it you love me serum and No treatment (usual skincare rutine) in Skin Hyperpigmentation and Dry Skin; Eczema, sponsored by University of Split, School of Medicine. Recruiting at 1 site in Croatia. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by University of Split, School of Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Jun 2023, registered Sep 2023).
  • Started Jun 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Sex
All
01

Study 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.

Read the detailed description

Skin hydration (as use of hydrating cosmetic ingredients) is one of the most interventions for healthy skin and skin barrier function. Therefore, cosmetic ingredients used for this purpose should be examined for their efficacy.

02

Conditions studied

  • Skin Hyperpigmentation
  • Dry Skin; Eczema
03

In context

Hyperpigmentation

127 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.

This study's planned enrollment of 25 is below the median of 32 across 113 interventional studies indexed under Hyperpigmentation.

Browse Hyperpigmentation studies →

Lead sponsor

University of Split, School of Medicine is the lead sponsor of 51 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy volunteers who gave written

Exclusion criteria

Exclusion Criteria:

  • skin disease, skin damage on measurement sites, use of 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    experimental arm

    Use of facial serum with niacinamide, plant-based collagen and peptides on randomized site on forehead

    Other: miss alice face it you love me serum

  • Placebo comparator
    placebo comparator

    No treatment (usual skincare rutine)

    Other: No treatment (usual skincare rutine)

Interventions

  • Othermiss alice face it you love me serum

    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

  • OtherNo treatment (usual skincare rutine)

    No treatment (usual skincare rutine)

06

What researchers measure

Primary outcomes

  1. TEWL assessment with Courage Khazaka probe

    Transepidermal water loss

    Time frame: through study completion, an average of 1 year

  2. Hydration assessment with corneometer probe

    stratum corneum hydration

    Time frame: through study completion, an average of 1 year

  3. pigmentation assessment with mexameter probe

    erythema and melanin

    Time frame: through study completion, an average of 1 year

  4. skin oiliness assessment with sebumeter probe

    sebum level

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. subjective opinion of participants

    participants notes on skin rection

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — upon request

Supporting information: Clinical study report

Time frame: upon request

Access criteria: upon request

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2023 (actual). Primary completion is estimated for Jun 2024, 11 months after the start.

Of 37 non-industry interventional studies with no phase under Hyperpigmentation, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 11 months is close to that.

Counting every sponsor, half of 64 studies reached it within 7 months; a quarter within 3 and three quarters within 25.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2023
First posted
Jan 3, 2024
StartActual
Jun 3, 2023
Primary completionEst.
Jun 1, 2024
CompletionEst.
Jun 1, 2024
Last update
Jan 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06189105
Lead sponsor
University of Split, School of Medicine
Responsible party
Dario Leskur (assistant professor, University of Split, School of Medicine) — Principal investigator
First posted
Jan 3, 2024
Start date
Jun 3, 2023
Primary completion
Jun 1, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Jan 3, 2024

Study contacts

Josipa Bukic
Contact
jbukic@mefst.hr
00385917933752
Dario Leskur
study director · USSM

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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