Normaderm Phytosolution Double-Correction Daily Care Moisturizer
DrugNormaderm Phytosolution (NP) was to be applied for up to 90 days once or twice daily, according to the investigator's prescription.
Other names: NP
NCT Number: NCT05483205
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.
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Notify Me18 year and older
All sexes
Observational
Buenos Aires, Caba, Argentina
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adult men or women (age >18 years old) with mild to moderate acne (GEA scale 1-3).
Exclusion criteria
Patients taking isotretinoin. Patients presenting with highly inflammatory acne, grade 4 or 5 on the GEA scale. Patients presenting with nodules.
Normaderm Phytosolution (NP) was to be applied for up to 90 days once or twice daily, according to the investigator's prescription.
Other names: NP
Time frame: 90-day use
Change in global acne severity
using a scale from 0=none to 5 very severe (GEA scale)
Time frame: 90-day use
assessed on a visual analog scale from 0 (absent) to 10 (severe
Time frame: 90-day use
assessed on a visual analog scale from 0=no hydration to 10=perfectly hydrated
Cosmetique Active International
Industry
Benefit of a Dermocosmetic in Mild to Moderate Adult Acne
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