Acne, AdultNCT05483205
Normaderm Phytosolution Global Observational Study
An observational study of Acne, Adult, run by Cosmetique Active International at 11 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne, Adult
- What is being tested?
- Normaderm Phytosolution Double-Correction Daily Care Moisturizer
- How many people
- 2,827 participants
- Where
- 11 sitesin 11 countries
- Study dates
- 1 Jul 2019to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult men or women (age >18 years old) with mild to moderate acne (GEA scale 1-3).
Who cannot join
- Patients taking isotretinoin. Patients presenting with highly inflammatory acne, grade 4 or 5 on the GEA scale. Patients presenting with nodules.
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
About this study
Official title: 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.
Read the 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
- Being tested
- Normaderm Phytosolution Double-Correction Daily Care Moisturizer
- Keywords
- acne, observational study, dermocosmetic
- Medical subject headings
- Acne, Adult, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normaderm Phytosolution Double-Correction Daily Care MoisturizerDrug
Also called NP
Normaderm Phytosolution (NP) was to be applied for up to 90 days once or twice daily, according to the investigator's prescription.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 90-day use
Secondary outcomes (2)
Change in seborrhea level
assessed on a visual analog scale from 0 (absent) to 10 (severe
Measured: 90-day use
Change in skin hydration
assessed on a visual analog scale from 0=no hydration to 10=perfectly hydrated
Measured: 90-day use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Jul 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,827 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Delphine Kerob, MD, Study director, Cosmetique Active International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483205
- Sponsor's protocol ID
- NP06072021
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of a Dermocosmetic in Mild to Moderate Adult Acne
- ClinicalTrials.gov ID
- NCT05483205
- Acronym / sponsor ID
- NP06072021
- Conditions
- Acne, Adult
- Keywords
- acne, observational study, dermocosmetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,827 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult men or women (age >18 years old) with mild to moderate acne (GEA scale 1-3).
Key exclusion criteria (1 listed)
- Patients taking isotretinoin. Patients presenting with highly inflammatory acne, grade 4 or 5 on the GEA scale. Patients presenting with nodules.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normaderm Phytosolution Double-Correction Daily Care MoisturizerAlso: NPNormaderm Phytosolution (NP) was to be applied for up to 90 days once or twice daily, according to the investigator's prescription. | Drug | – |
Primary outcome
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)
2 secondary outcomes
Change in seborrhea level
Time frame: 90-day use
Change in skin hydration
Time frame: 90-day use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
Related trials for Acne, Adult
Active, not recruitingPhase 2
Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)
Hidradenitis Suppurativa
Active, not recruitingPhase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa
Not yet recruitingPhase 2
Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity
Hidradenitis Suppurativa
RecruitingObservational study
The Impact of Baseline Hormonal Profiles (DHEAS, FSH, LH) on Treatment Response to Systemic Isotretinoin in Adult Female Patients With Acne Vulgaris
Acne Vulgaris
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delphine Kerob, MD study director
Cosmetique Active International
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne, Adult, run by Cosmetique Active International at 11 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Argentina, Bulgaria, Czechia, Germany, Hungary and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.