M89PF in Rosacea Associated With Erythema and Sensitive Skin

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05562661

Enrollment

Registered

2022-10-03

Start date

2021-01-02

Completion date

2021-02-28

Last updated

2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rosacea

Keywords

rosacea, skin barrier, exposome, M89PF, splitface, sensitive skin

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
erythema	Day 0	assessment using a chromameter
skin hydration	Day 0	using a corneometer
transepidermal water loss	Day 0	tewameter

Secondary

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

Countries

Italy

Outcome results