Clinical trial NCT05562661: M89PF in Rosacea Associated With Erythema and Sensitive Skin
Official title: A Randomized, Controlled Clinical Trial of M89PF in Rosacea Associated With Erythema and Sensitive Skin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rosacea
Keywords: rosacea
skin barrier
exposome
M89PF
splitface
sensitive skin
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2022-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: erythema
timeFrame: Day 0
measure: erythema
timeFrame: Day 15
measure: erythema
timeFrame: Day 30
measure: skin hydration
timeFrame: Day 0
measure: skin hydration
timeFrame: Day 15
measure: skin hydration
timeFrame: Day 30
measure: transepidermal water loss
timeFrame: Day 0
measure: transepidermal water loss
timeFrame: Day 15
measure: transepidermal water loss
timeFrame: Day 30
Secondary outcomes:
measure: clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)
timeFrame: Day 0
measure: clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)
timeFrame: Day 15
measure: clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)
timeFrame: Day 30
measure: skin sensitivity
timeFrame: Day 0
measure: skin sensitivity
timeFrame: Day 15
measure: skin sensitivity
timeFrame: Day 30
measure: Demodex density
timeFrame: Day 0
measure: Demodex density
timeFrame: Day 30
measure: local tolerability
timeFrame: Day 15
measure: local tolerability
timeFrame: Day 30
measure: subject satisfaction
timeFrame: Day 15
measure: subject satisfaction
timeFrame: Day 30
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ISPE
Study officials:
affiliation: Laboratoires Vichy, Levallois-Perret France
name: Delphine Kerob, MD
role: STUDY_DIRECTOR
References: