Normaderm Phytosolution Global Observational Study

Completed

• Conditions: Acne, Adult

• Registration Number: NCT05483205
• Lead Sponsor: Cosmetique Active International

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.

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 Timeline

• Study Start: 2019-07-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2022-07
• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-08-01
• Last Update Submitted: 2022-08-01
• Study First Posted: 2022-08-02
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2827

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (11)

EuroDerma Clinic; 🇧🇬 Sofia, Bulgaria

State Dermatological Clinic #10; 🇷🇺 Saint Petersburg, Russian Federation

Amdv s.r.o. kozna amb; 🇸🇰 Prešov, Slovakia

Gazi University Medical School; 🇹🇷 Ankara, Turkey

Buenos Aires; 🇦🇷 Caba, Argentina

Polimed; 🇵🇱 Wrocław, Poland

DClinic; 🇷🇴 Bucharest, Romania

Charite Universitatsklinikum; 🇩🇪 Berlin, Germany

DermaMedEst; 🇨🇿 Praha, Czechia

Eiffel Esthetics; 🇭🇺 Budapest, Hungary

Dermaarte Polanco; 🇲🇽 Polanco, Mexico