NCT05483205

Normaderm Phytosolution Global Observational Study

Benefit of a Dermocosmetic in Mild to Moderate Adult Acne

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,827 (actual)
• Sponsor: Cosmetique Active International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this 3-month observational study was to assess, in 2827 adults, the benefit of NP alone or as adjunctive or maintenance care in mild acne, or as adjunctive care in subjects with moderate acne.

Detailed description

Acne is a chronic inflammatory condition, impacted by exposome factors. A dermocosmetic, Normaderm Phytosolution (NP), was developed to target hyperkeratosis, inflammation, and sebum, while protecting the skin barrier, and to be used either alone or in addition to acne medications. NP is a dermocosmetic specifically developed for acne-prone skin. The lightweight cream is easily absorbed and targets acne pathogenesis thanks to salicylic acid 2% for skin exfoliation, phyco-saccharide 2% for sebum reduction, and vitamin CG as anti-inflammatory ingredient, as well as ingredients that enable regeneration of the disrupted skin barrier, such as Vichy mineralizing water 60%, Bifida ferment lysate 1%, and hyaluronic acid 0.2%. The study was conducted in accordance with the protocol and the legislative and regulatory provisions in force (after obtaining authorization of the French health authorities and the favorable opinion of the ethics committee). Qualitative variables were described as numbers and percentages. 95% confidence intervals (CI) were calculated, where required. Quantitative variables were described as number, mean, standard deviation, median, minimum, maximum and number of missing data. All statistical analyses were performed at a 5% significance using 2-sided tests, except normality, tested at the threshold of 1% (Shapiro-Wilk test).

Conditions

• Acne, Adult

Interventions

Type	Name	Description
DRUG	Normaderm Phytosolution Double-Correction Daily Care Moisturizer	Normaderm Phytosolution (NP) was to be applied for up to 90 days once or twice daily, according to the investigator's prescription.

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2022-08-02
• Last updated: 2022-08-02

Locations

11 sites across 11 countries: Argentina, Bulgaria, Czechia, Germany, Hungary, Mexico, Poland, Romania, Russia, Slovakia, Turkey (Türkiye)