M89PF in Rosacea Associated With Erythema and Sensitive Skin

Completed

• Conditions: Rosacea

• Registration Number: NCT05562661
• Lead Sponsor: Cosmetique Active International

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.

Study Timeline

• Study Start: 2021-01-02
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2022-09
• Study First Submitted: 2022-09-25
• Study First Submitted QC: 2022-09-28
• Last Update Submitted: 2022-09-28
• Study First Posted: 2022-10-03
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
transepidermal water loss	Day 30	tewameter
erythema	Day 30	assessment using a chromameter
skin hydration	Day 30	using a corneometer

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ISPE; 🇮🇹 Milan, Italy