A single arm clinical study to evaluate the efficacy of Niacinamide Serum for skin pigmentation and gloss

UAS Pharmaceuticals Pty Ltd1 个研究点分布在 1 个国家目标入组 32 人开始时间: 2025年10月6日

试验速览

An open label one arm study.

Each participant entering the trial will be assigned to a regimen of investigational product with the below assessments.

Product to be applied at face and neck both.

Skin Gloss by Glossymeter (T0, day 14 and day 28 )
Skin Pigmentation by Mexameter Face (Melanin Index) (Day 0, 14, 28)
Skin Hydration by Corneometer (T0, day14 and day 28)
Dark Spots by Visioface (Day 0, 14, 28)
Sebum by Sebumeter ( Day 0,14,28)
Wrinkles by Visioface ( Day 0,14,28)
Skin Barrier by TEWAMETER (Day 0,14,28)
Dermat evaluation on a 5-point ordinal scale would be used for the Even Skin Tone (Day 0, 14,28)
Dermat evaluation on a 5-point ordinal scale would be used for the Skin Texture (Day 0, 14,28)
Dermat evaluation on a 5-point ordinal scale would be used for the Smooth skin (Day 0, 14,28)
Visioscan Images Day 0, and Day 28
HD Imaging with DSLR (Day 0 and Day 28 )
Subject’s Self Assessments. (day 28 )

Test Product: Niacinamide Serum Dose: Gently use the Niacinamide serum on the face twice a day for 4 weeks. Route of Administration: Topical

Subjects will be on study for up to 28 days. Screening & Assigning: Day 1 Follow-ups: on Day 1-30min, and Day 14 EOT: Day 28

•Gender: Male or Female with age 18-45 2) Subjects with oily skin , have hyperpigmentation .
•Subjects willing to give written informed consent 4) Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
•Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
•Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.

•Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
•Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
•Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
•Have participated in any interventional clinical trial in the previous 90 days.
•Have a known sensitivity to any of the constituents of the test product
•Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
•Have not skin related issues.