Skin HyperpigmentationNCT06189105
Efficacy and Safety Assessment of Niacinamide Cosmetic Preparation: a Randomized Controlled Trial
A study testing miss alice face it you love me serum and No treatment (usual skincare rutine) in people with Skin Hyperpigmentation and Dry Skin; Eczema, run by University of Split, School of Medicine at 1 site in Croatia.
Trial 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 more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Skin Hyperpigmentation, Dry Skin; Eczema
- What is being tested?
- miss alice face it you love me serum and No treatment (usual skincare rutine)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCroatia
- Study dates
- 3 Jun 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy volunteers who gave written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University of Split School of Medicine
Split
Josipa Bukic, 00385917933752, jbukic@mefst.hr
About this study
Official title: Testing the Efficacy and Safety of Niacinamide Cosmetic Preparation: A Randomised, Controlled Trial
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.
- Conditions
- Skin Hyperpigmentation, Dry Skin; Eczema
- Being tested
- miss alice face it you love me serum, No treatment (usual skincare rutine)
- Medical subject headings
- Hyperpigmentation, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miss alice face it you love me serumOther
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
No treatment (usual skincare rutine)Other
No treatment (usual skincare rutine)
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | Use of facial serum with
niacinamide, plant-based collagen and
peptides on randomized site on forehead Receives: Other: miss alice face it you love me serum |
| placebo comparator | Placebo comparator | No treatment (usual
skincare rutine) Receives: Other: No treatment (usual skincare rutine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEWL assessment with Courage Khazaka probe
Transepidermal water loss
Measured: through study completion, an average of 1 year
Hydration assessment with corneometer probe
stratum corneum hydration
Measured: through study completion, an average of 1 year
pigmentation assessment with mexameter probe
erythema and melanin
Measured: through study completion, an average of 1 year
skin oiliness assessment with sebumeter probe
sebum level
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
subjective opinion of participants
participants notes on skin rection
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start3 Jun 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dario Leskur, University of Split, School of Medicine
- Investigators
- Dario Leskur, Study director, USSM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189105
- Sponsor's protocol ID
- 2181-198-03-04-23-032
- Status last verified
- Dec 2023
- First submitted
- 13 Sep 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon request
Publications
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.
PubMed 39768384
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy and Safety of Niacinamide Cosmetic Preparation: A Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT06189105
- Acronym / sponsor ID
- 2181-198-03-04-23-032
- Conditions
- Skin Hyperpigmentation, Dry Skin; Eczema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Other: miss alice face it you love me serumUse of facial serum with niacinamide, plant-based collagen and peptides on randomized site on forehead |
| placebo comparator | Placebo comparator | Other: No treatment (usual skincare rutine)No treatment (usual skincare rutine) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers who gave written informed consent
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miss alice face it you love me serumFacial serum with niacinamide, plant-based collagen and peptides will be applied by each participant to the treatment site according to randomization protocol every evening | Other | experimental arm |
| No treatment (usual skincare rutine)No treatment (usual skincare rutine) | Other | placebo comparator |
Primary outcome
TEWL assessment with Courage Khazaka probe
Time frame: through study completion, an average of 1 year
Transepidermal water loss
Hydration assessment with corneometer probe
Time frame: through study completion, an average of 1 year
stratum corneum hydration
pigmentation assessment with mexameter probe
Time frame: through study completion, an average of 1 year
erythema and melanin
skin oiliness assessment with sebumeter probe
Time frame: through study completion, an average of 1 year
sebum level
1 secondary outcome
subjective opinion of participants
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 39768384Rusic 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.
- Individual participant dataSharing planned: Yes. upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dario Leskur study director
USSM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing miss alice face it you love me serum and No treatment (usual skincare rutine) in people with Skin Hyperpigmentation and Dry Skin; Eczema, run by University of Split, School of Medicine at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josipa Bukic (00385917933752, jbukic@mefst.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEWL assessment with Courage Khazaka probe (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06189105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.