Skip to main content
OpenTrials
Completed

NCT Number: NCT05483205

Normaderm Phytosolution Global Observational Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Buenos Aires, Caba, Argentina

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Normaderm Phytosolution Double-Correction Daily Care Moisturizer

Drug

Normaderm Phytosolution (NP) was to be applied for up to 90 days once or twice daily, according to the investigator's prescription.

Other names: NP

Primary outcomes

  1. Benefit of NP alone or as adjunctive or maintenance care in mild acne, or as adjunctive care in subjects with moderate acne.

    Time frame: 90-day use

    Change in global acne severity

    using a scale from 0=none to 5 very severe (GEA scale)

Secondary outcomes

  1. Change in seborrhea level

    Time frame: 90-day use

    assessed on a visual analog scale from 0 (absent) to 10 (severe

  2. Change in skin hydration

    Time frame: 90-day use

    assessed on a visual analog scale from 0=no hydration to 10=perfectly hydrated

Sponsors and collaborators

Lead sponsor

Cosmetique Active International

Industry

Registry information

Official study title

Benefit of a Dermocosmetic in Mild to Moderate Adult Acne

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2022
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.