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NCT05562661 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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