M89PF in Rosacea Associated With Erythema and Sensitive Skin

Sponsor

Cosmetique Active International (Industry)

Overall Status

Completed

CT.gov ID

NCT05562661

Collaborator

(none)

Enrollment

Location

1.9

Actual Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 2, 2021

Actual Primary Completion Date :

Feb 28, 2021

Actual Study Completion Date :

Feb 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
M89PF/standard skin care use of M89PF on one side of the face standard skin care products on the other side of the face

Outcome Measures

Primary Outcome Measures

erythema [Day 0]
assessment using a chromameter
erythema [Day 15]
assessment using a chromameter
erythema [Day 30]
assessment using a chromameter
skin hydration [Day 0]
using a corneometer
skin hydration [Day 15]
using a corneometer
skin hydration [Day 30]
using a corneometer
transepidermal water loss [Day 0]
tewameter
transepidermal water loss [Day 15]
tewameter
transepidermal water loss [Day 30]
tewameter

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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)