Clinical trial NCT05483205: Normaderm Phytosolution Global Observational Study
Official title: Benefit of a Dermocosmetic in Mild to Moderate Adult Acne
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne, Adult
Keywords: acne
observational study
dermocosmetic
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2022-08-02
Enrollment: 2827
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study took place at 337 sites in 11 countries worlwide. The study population consisted of 2827 patients. Overall, 75.3% were females; mean age was 26.7±8.0 years; 48% of subjects were aged between 18 and 25 years.

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).

Eligibility 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.

Primary outcomes:
measure: Benefit of NP alone or as adjunctive or maintenance care in mild acne, or as adjunctive care in subjects with moderate acne.
timeFrame: 90-day use
Secondary outcomes:
measure: Change in seborrhea level
timeFrame: 90-day use
measure: Change in skin hydration
timeFrame: 90-day use
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Buenos Aires
city: Sofia
country: Bulgaria
facility: EuroDerma Clinic
city: Praha
country: Czechia
facility: DermaMedEst
city: Berlin
country: Germany
facility: Charite Universitatsklinikum
city: Budapest
country: Hungary
facility: Eiffel Esthetics
city: Polanco
country: Mexico
facility: Dermaarte Polanco
city: Wrocław
country: Poland
facility: Polimed
city: Bucharest
country: Romania
facility: DClinic
city: Saint Petersburg
country: Russian Federation
facility: State Dermatological Clinic #10
city: Prešov
country: Slovakia
facility: Amdv s.r.o. kozna amb
city: Ankara
country: Turkey
facility: Gazi University Medical School
Study officials:
affiliation: Cosmetique Active International
name: Delphine Kerob, MD
role: STUDY_DIRECTOR
References: