M89PF in Rosacea Associated With Erythema and Sensitive Skin

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05562661
• Other study ID #: M89PF splitface
• Status: Completed
• Start date: January 2, 2021
• Est. completion date: February 28, 2021

Study information

• Verified date: September 2022
• Source: Cosmetique Active International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Erythema
• Hypersensitivity
• Rosacea

Locations

Country	Name	City	State
Italy	ISPE	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Cosmetique Active International

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	erythema	assessment using a chromameter	Day 0
Primary	erythema	assessment using a chromameter	Day 15
Primary	erythema	assessment using a chromameter	Day 30
Primary	skin hydration	using a corneometer	Day 0
Primary	skin hydration	using a corneometer	Day 15
Primary	skin hydration	using a corneometer	Day 30
Primary	transepidermal water loss	tewameter	Day 0
Primary	transepidermal water loss	tewameter	Day 15
Primary	transepidermal water loss	tewameter	Day 30
Secondary	clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)	VAS 0=none to 10=very severe	Day 0
Secondary	clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)	VAS 0=none to 10=very severe	Day 15
Secondary	clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)	VAS 0=none to 10=very severe	Day 30
Secondary	skin sensitivity	lactic acid skin stinging test	Day 0
Secondary	skin sensitivity	lactic acid skin stinging test	Day 15
Secondary	skin sensitivity	lactic acid skin stinging test	Day 30
Secondary	Demodex density	SSSB method	Day 0
Secondary	Demodex density	SSSB method	Day 30
Secondary	local tolerability	AE questioning	Day 15
Secondary	local tolerability	AE questioning	Day 30
Secondary	subject satisfaction	questionnaire on a scale from 0= very unsatisfied to 5 very satisfied	Day 15
Secondary	subject satisfaction	questionnaire on a scale from 0= very unsatisfied to 5 very satisfied	Day 30