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Completed

NCT Number: NCT05562661

M89PF in Rosacea Associated With Erythema and Sensitive Skin

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.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ISPE

Milan, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. erythema

    Time frame: Day 0

    assessment using a chromameter

  2. erythema

    Time frame: Day 15

    assessment using a chromameter

  3. erythema

    Time frame: Day 30

    assessment using a chromameter

  4. skin hydration

    Time frame: Day 0

    using a corneometer

  5. skin hydration

    Time frame: Day 15

    using a corneometer

  6. skin hydration

    Time frame: Day 30

    using a corneometer

  7. transepidermal water loss

    Time frame: Day 0

    tewameter

  8. transepidermal water loss

    Time frame: Day 15

    tewameter

  9. transepidermal water loss

    Time frame: Day 30

    tewameter

Secondary outcomes

  1. clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)

    Time frame: Day 0

    VAS 0=none to 10=very severe

  2. clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)

    Time frame: Day 15

    VAS 0=none to 10=very severe

  3. clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)

    Time frame: Day 30

    VAS 0=none to 10=very severe

  4. skin sensitivity

    Time frame: Day 0

    lactic acid skin stinging test

  5. skin sensitivity

    Time frame: Day 15

    lactic acid skin stinging test

  6. skin sensitivity

    Time frame: Day 30

    lactic acid skin stinging test

  7. Demodex density

    Time frame: Day 0

    SSSB method

  8. Demodex density

    Time frame: Day 30

    SSSB method

  9. local tolerability

    Time frame: Day 15

    AE questioning

  10. local tolerability

    Time frame: Day 30

    AE questioning

  11. subject satisfaction

    Time frame: Day 15

    questionnaire on a scale from 0= very unsatisfied to 5 very satisfied

  12. subject satisfaction

    Time frame: Day 30

    questionnaire on a scale from 0= very unsatisfied to 5 very satisfied

Sponsors and collaborators

Lead sponsor

Cosmetique Active International

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2022
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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