Normaderm Phytosolution Global Observational Study

Study Overview
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Brief Summary
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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
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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).

Official Title
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Benefit of a Dermocosmetic in Mild to Moderate Adult Acne

Conditions
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Acne, Adult

Intervention / Treatment
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* Drug: Normaderm Phytosolution Double-Correction Daily Care Moisturizer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benefit of NP alone or as adjunctive or maintenance care in mild acne, or as adjunctive care in subjects with moderate acne. | Change in global acne severity using a scale from 0=none to 5 very severe (GEA scale) | 90-day use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in seborrhea level | assessed on a visual analog scale from 0 (absent) to 10 (severe | 90-day use | 
| Change in skin hydration | assessed on a visual analog scale from 0=no hydration to 10=perfectly hydrated | 90-day use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne, observational study, dermocosmetic