M89PF in Rosacea Associated With Erythema and Sensitive Skin

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.

Study Overview

• Status: Completed
• Conditions: Rosacea

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • ISPE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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)

Description

Inclusion Criteria:

Adult subjects with rosacea associated with erythema and less than 3 papules or pustules and having sensitive skin (positive 15% lactic acid sting test)

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
erythema	assessment using a chromameter	Day 0
erythema	assessment using a chromameter	Day 15
erythema	assessment using a chromameter	Day 30
skin hydration	using a corneometer	Day 0
skin hydration	using a corneometer	Day 15
skin hydration	using a corneometer	Day 30
transepidermal water loss	tewameter	Day 0
transepidermal water loss	tewameter	Day 15
transepidermal water loss	tewameter	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)	VAS 0=none to 10=very severe	Day 0
clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)	VAS 0=none to 10=very severe	Day 15
clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)	VAS 0=none to 10=very severe	Day 30
skin sensitivity	lactic acid skin stinging test	Day 0
skin sensitivity	lactic acid skin stinging test	Day 15
skin sensitivity	lactic acid skin stinging test	Day 30
Demodex density	SSSB method	Day 0
Demodex density	SSSB method	Day 30
local tolerability	AE questioning	Day 15
local tolerability	AE questioning	Day 30
subject satisfaction	questionnaire on a scale from 0= very unsatisfied to 5 very satisfied	Day 15
subject satisfaction	questionnaire on a scale from 0= very unsatisfied to 5 very satisfied	Day 30

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Investigators: Study Director: Delphine Kerob, MD, Laboratoires Vichy, Levallois-Perret France

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2021
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: September 25, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: rosacea; sensitive skin; skin barrier; exposome; M89PF; splitface
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Skin Manifestations; Hypersensitivity; Rosacea; Erythema
• Other Study ID Numbers: M89PF splitface

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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