Normaderm Phytosolution Global Observational Study

Benefit of a Dermocosmetic in Mild to Moderate Adult Acne

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.

Study Overview

• Status: Completed
• Conditions: Acne, Adult
• Intervention / Treatment: Drug: Normaderm Phytosolution Double-Correction Daily Care Moisturizer

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 Type: Observational
• Enrollment (Actual): 2827

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina
    • Buenos Aires
• Bulgaria
  • Sofia, Bulgaria
    • EuroDerma Clinic
• Czechia
  • Praha, Czechia
    • DermaMedEst
• Germany
  • Berlin, Germany
    • Charité Universitätsklinikum
• Hungary
  • Budapest, Hungary
    • Eiffel Esthetics
• Mexico
  • Polanco, Mexico
    • Dermaarte Polanco
• Poland
  • Wrocław, Poland
    • POLIMED
• Romania
  • Bucharest, Romania
    • DClinic
• Russian Federation
  • Saint Petersburg, Russian Federation
    • State Dermatological Clinic #10
• Slovakia
  • Prešov, Slovakia
    • Amdv s.r.o. kozna amb
• Turkey
  • Ankara, Turkey
    • Gazi University Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Investigators: Study Director: Delphine Kerob, MD, Cosmetique Active International

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: observational study; acne; dermocosmetic
• Other Study ID Numbers: NP06072021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No