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Clinical Benefit of M89PB in Subjects With Rosacea Associated With Erythema and Sensitive Skin

NCT04898582 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-05-24

No results posted yet for this study

Summary

The aim of the study is to assess the efficacy of the product M89 probiotic fractions in improving the symptoms of rosacea patients with sensitive skin after 30 days of treatment, in comparison with an area treated with the habitual skin care product.

20 women with sensitive skin (positive reaction to stinging test), suffering from persistent centrofacial erythema of rosacea with no more than 3 papules and pustules apply the product on half a face, twice a day, for 30 days. The subjects use their habitual skin care product on the other side of the face.

The product efficacy is supported by significant improvements in the mean basal values of the following instrumental parameters: skin hydration (increase), trans-epidermal water loss (decrease), skin erythema (a\* parameter decrease).

The efficacy and the tolerability of the product is also showed by a visual clinical assessment of the face skin conditions and by stinging test. Digital images of the face of the subjects were also taken at each control time.

Furthermore, the volunteers express their judgement on the efficacy and the pleasantness of the product by means of a self-assessment questionnaire.

Conditions

  • Rosacea
  • Sensitive Skin

Interventions

OTHER

Mineral 89 Probiotic Fractions

The subjects applied the product M89 Probiotic Fractions on half a face, twice a day, in the morning and in the evening, for 30 days. They put two drops of the product in the palm of their hand and gently massage with their fingertips on half face. The face skin had to be cleaned and dried before the application of the product. The subjects used their standard skin care product on the side of the face not treated with M89 Probiotic Fractions

Sponsors & Collaborators

  • Institute of Skin and Product Evaluation, Italy

    lead OTHER

Principal Investigators

  • Claudia Cartigliani · ISPE srl

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2021-05-18
Completion
2021-05-18

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04898582 on ClinicalTrials.gov