RosaceaNCT05562661
M89PF in Rosacea Associated With Erythema and Sensitive Skin
An observational study of Rosacea, run by Cosmetique Active International at 1 site in Italy.
Trial summary
Rosacea is a common facial dermatosis, with flares induced by exposome factors. M89PF containing Vichy mineralizing water, probiotic fractions, hyaluronic acid, niacinamide and tocopherol repairs the skin barrier and reinforces skin defences against exposome factors. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2021to 28 Feb 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult subjects with rosacea associated with erythema and less than 3 papules or pustules and having sensitive skin (positive 15% lactic acid sting test)
Who may be able to join
- Adult subjects with rosacea associated with erythema and less than 3 papules or pustules and having sensitive skin (positive 15% lactic acid sting test)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Clinical Trial of M89PF in Rosacea Associated With Erythema and Sensitive Skin
Rosacea is a common facial dermatosis, with flares induced by exposome factors. M89PF containing Vichy mineralizing water, probiotic fractions, hyaluronic acid, niacinamide and tocopherol repairs the skin barrier and reinforces skin defences against exposome factors.
This study assessed the benefit of M89PF in patients with rosacea associated with erythema and sensitive skin during the Covid-19 pandemic with use of protective face masks.
Read the detailed description
M89PF was compared to usual skin care in a randomized, split-face study, for 30 days in subjects with rosacea associated with erythema and sensitive skin. Clinical evaluations included erythema, desquamation, skin tightness, dryness, burning sensation, itching, stinging, stinging test, and local tolerability. Instrument evaluations included erythema, skin hydration and TEWL. Subject satisfaction was also assessed.
- Conditions
- Rosacea
- Keywords
- rosacea, skin barrier, exposome, M89PF, splitface, sensitive skin
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| M89PF/standard skin care | use of M89PF on one side of the face standard skin care products on the other side of the face |
What is being measured
The primary outcome is the main question the study is designed to answer.
erythema
assessment using a chromameter
Measured: Day 0
erythema
assessment using a chromameter
Measured: Day 15
erythema
assessment using a chromameter
Measured: Day 30
skin hydration
using a corneometer
Measured: Day 0
skin hydration
using a corneometer
Measured: Day 15
skin hydration
using a corneometer
Measured: Day 30
transepidermal water loss
tewameter
Measured: Day 0
transepidermal water loss
tewameter
Measured: Day 15
transepidermal water loss
tewameter
Measured: Day 30
Secondary outcomes (12)
clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)
VAS 0=none to 10=very severe
Measured: Day 0
clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)
VAS 0=none to 10=very severe
Measured: Day 15
clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)
VAS 0=none to 10=very severe
Measured: Day 30
skin sensitivity
lactic acid skin stinging test
Measured: Day 0
skin sensitivity
lactic acid skin stinging test
Measured: Day 15
skin sensitivity
lactic acid skin stinging test
Measured: Day 30
Demodex density
SSSB method
Measured: Day 0
Demodex density
SSSB method
Measured: Day 30
local tolerability
AE questioning
Measured: Day 15
local tolerability
AE questioning
Measured: Day 30
subject satisfaction
questionnaire on a scale from 0= very unsatisfied to 5 very satisfied
Measured: Day 15
subject satisfaction
questionnaire on a scale from 0= very unsatisfied to 5 very satisfied
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start2 Jan 2021
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RosaceaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 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, Laboratoires Vichy, Levallois-Perret France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562661
- Sponsor's protocol ID
- M89PF splitface
- Status last verified
- Sep 2022
- First submitted
- 25 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berardesca E, Bonfigli A, Cartigliani C, Kerob D, Tan J. A Randomized, Controlled Clinical Trial of a Dermocosmetic Containing Vichy Volcanic Mineralizing Water and Probiotic Fractions in Subjects with Rosacea Associated with Erythema and Sensitive Skin and Wearing Protective Masks. Clin Cosmet Investig Dermatol. 2023 Jan 11;16:71-77. doi: 10.2147/CCID.S391893. eCollection 2023.
PubMed 36660190
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Trial of M89PF in Rosacea Associated With Erythema and Sensitive Skin
- ClinicalTrials.gov ID
- NCT05562661
- Acronym / sponsor ID
- M89PF splitface
- Conditions
- Rosacea
- Keywords
- rosacea, skin barrier, exposome, M89PF, splitface, sensitive skin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 3 Oct 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.
Rosacea is a common facial dermatosis, with flares induced by exposome factors. M89PF containing Vichy mineralizing water, probiotic fractions, hyaluronic acid, niacinamide and tocopherol repairs the skin barrier and reinforces skin defences against exposome factors.
This study assessed the benefit of M89PF in patients with rosacea associated with erythema and sensitive skin during the Covid-19 pandemic with use of protective face masks.
Detailed description
M89PF was compared to usual skin care in a randomized, split-face study, for 30 days in subjects with rosacea associated with erythema and sensitive skin. Clinical evaluations included erythema, desquamation, skin tightness, dryness, burning sensation, itching, stinging, stinging test, and local tolerability. Instrument evaluations included erythema, skin hydration and TEWL. Subject satisfaction was also assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M89PF/standard skin care | – | –use of M89PF on one side of the face standard skin care products on the other side of the face |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with rosacea associated with erythema and less than 3 papules or pustules and having sensitive skin (positive 15% lactic acid sting test)
Key inclusion criteria (1 listed)
- Adult subjects with rosacea associated with erythema and less than 3 papules or pustules and having sensitive skin (positive 15% lactic acid sting test)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
erythema
Time frame: Day 0
assessment using a chromameter
erythema
Time frame: Day 15
assessment using a chromameter
erythema
Time frame: Day 30
assessment using a chromameter
skin hydration
Time frame: Day 0
using a corneometer
skin hydration
Time frame: Day 15
using a corneometer
skin hydration
Time frame: Day 30
using a corneometer
transepidermal water loss
Time frame: Day 0
tewameter
transepidermal water loss
Time frame: Day 15
tewameter
transepidermal water loss
Time frame: Day 30
tewameter
12 secondary outcomes
clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)
Time frame: Day 0
clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)
Time frame: Day 15
clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)
Time frame: Day 30
skin sensitivity
Time frame: Day 0
skin sensitivity
Time frame: Day 15
skin sensitivity
Time frame: Day 30
Demodex density
Time frame: Day 0
Demodex density
Time frame: Day 30
local tolerability
Time frame: Day 15
local tolerability
Time frame: Day 30
subject satisfaction
Time frame: Day 15
subject satisfaction
Time frame: Day 30
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 3 Oct 2022.
- Derived from this study: PubMed 36660190Berardesca E, Bonfigli A, Cartigliani C, Kerob D, Tan J. A Randomized, Controlled Clinical Trial of a Dermocosmetic Containing Vichy Volcanic Mineralizing Water and Probiotic Fractions in Subjects with Rosacea Associated with Erythema and Sensitive Skin and Wearing Protective Masks. Clin Cosmet Investig Dermatol. 2023 Jan 11;16:71-77. doi: 10.2147/CCID.S391893. eCollection 2023.
- Individual participant dataSharing planned: No
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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
Laboratoires Vichy, Levallois-Perret France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rosacea, run by Cosmetique Active International at 1 site in Italy.
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 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
erythema (time frame: Day 0). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562661, which also lists 1 linked publication.
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 3 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.