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

Dry Skin; Eczema Clinical Trial

Official title:

Testing the Efficacy and Safety of Niacinamide Cosmetic Preparation: A Randomised, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06189105
• Other study ID #: 2181-198-03-04-23-032
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: December 2023
• Source: University of Split, School of Medicine
• Contact: Josipa Bukic
• Phone: 00385917933752
• Email: jbukic[@]mefst.hr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dry Skin; Eczema
• Hyperpigmentation
• Skin Hyperpigmentation

Intervention

Other:
• miss 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
• No treatment (usual skincare rutine)
No treatment (usual skincare rutine)

Locations

Country	Name	City	State
Croatia	University of Split School of Medicine	Split

Sponsors (1)

Lead Sponsor	Collaborator
University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TEWL assessment with Courage Khazaka probe	Transepidermal water loss	through study completion, an average of 1 year
Primary	Hydration assessment with corneometer probe	stratum corneum hydration	through study completion, an average of 1 year
Primary	pigmentation assessment with mexameter probe	erythema and melanin	through study completion, an average of 1 year
Primary	skin oiliness assessment with sebumeter probe	sebum level	through study completion, an average of 1 year
Secondary	subjective opinion of participants	participants notes on skin rection	through study completion, an average of 1 year