Normaderm Phytosolution Global Observational Study

NCT ID: NCT05483205

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2827 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-06-30

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).

Conditions

Acne, Adult

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

NP

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cosmetique Active International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Delphine Kerob, MD

Role: STUDY_DIRECTOR

Cosmetique Active International

Locations

Buenos Aires

Caba, , Argentina

EuroDerma Clinic

Sofia, , Bulgaria

DermaMedEst

Prague, , Czechia

Charite Universitatsklinikum

Berlin, , Germany

Eiffel Esthetics

Budapest, , Hungary

Dermaarte Polanco

Polanco, , Mexico

Polimed

Wroclaw, , Poland

DClinic

Bucharest, , Romania

State Dermatological Clinic #10

Saint Petersburg, , Russia

Amdv s.r.o. kozna amb

Prešov, , Slovakia

Gazi University Medical School

Ankara, , Turkey (Türkiye)

Countries

Argentina; Bulgaria; Czechia; Germany; Hungary; Mexico; Poland; Romania; Russia; Slovakia; Turkey (Türkiye)

Other Identifiers

NP06072021

Identifier Type: -

Identifier Source: org_study_id