M89PF in Rosacea Associated With Erythema and Sensitive Skin

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Controlled Clinical Trial of M89PF in Rosacea Associated With Erythema and Sensitive Skin

Conditions
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Rosacea

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| M89PF/standard skin care<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rosacea, skin barrier, exposome, M89PF, splitface, sensitive skin