Normaderm Phytosolution Global Observational Study
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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).
Study Design
Outcome Measures
Primary Outcome Measures
- Benefit of NP alone or as adjunctive or maintenance care in mild acne, or as adjunctive care in subjects with moderate acne. [90-day use]
Change in global acne severity using a scale from 0=none to 5 very severe (GEA scale)
Secondary Outcome Measures
- Change in seborrhea level [90-day use]
assessed on a visual analog scale from 0 (absent) to 10 (severe
- Change in skin hydration [90-day use]
assessed on a visual analog scale from 0=no hydration to 10=perfectly hydrated
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Buenos Aires | Caba | Argentina | ||
| 2 | EuroDerma Clinic | Sofia | Bulgaria | ||
| 3 | DermaMedEst | Praha | Czechia | ||
| 4 | Charite Universitatsklinikum | Berlin | Germany | ||
| 5 | Eiffel Esthetics | Budapest | Hungary | ||
| 6 | Dermaarte Polanco | Polanco | Mexico | ||
| 7 | Polimed | Wrocław | Poland | ||
| 8 | DClinic | Bucharest | Romania | ||
| 9 | State Dermatological Clinic #10 | Saint Petersburg | Russian Federation | ||
| 10 | Amdv s.r.o. kozna amb | Prešov | Slovakia | ||
| 11 | Gazi University Medical School | Ankara | Turkey |
Sponsors and Collaborators
- Cosmetique Active International
Investigators
- Study Director: Delphine Kerob, MD, Cosmetique Active International
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NP06072021