Status:
UNKNOWN
Clinical Benefit of M89PB in Subjects With Rosacea Associated With Erythema and Sensitive Skin
Lead Sponsor:
Institute of Skin and Product Evaluation, Italy
Conditions:
Rosacea
Sensitive Skin
Eligibility:
FEMALE
20-60 years
Phase:
NA
Brief 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 a...
Detailed Description
The test was carried out in a temperature and humidity-controlled room (24 ± 2 °C; 50 ± 10 % r.h.). 20 female subjects, between 20 and 60 years old, phototype I-IV according to Fitzpatrick skin type ...
Eligibility Criteria
Inclusion
- Caucasian subjects of female sex, 20-60 years old, phototype I-IV according to Fitzpatrick skin type classification and in good general health.
- Subjects with sensitive skin (positive reaction to stinging test, score ≥ 3).
- Subjects suffering from persistent centrofacial erythema of rosacea with no more than 3 papules and pustules.
- Subjects able to follow all study directions and willing to commit to all follow-up visits for the duration of the study.
- Subjects who have completed the written informed consent process.
- Subjects who avoid the exposure to UV radiation and the use of tanning beds for the duration of the study.
Exclusion
- Pregnant or nursing females.
- Subjects with Rosacea and more than 3 papules or pustules.
- Subjects who are taking topical or systemic drugs that could affect the results of the test (immunosuppressants, anti-inflammatory agents, corticosteroids, etc.).
- Subjects with a change in contraception.
- Subjects showing systemic diseases or skin disorders (such as eczema, psoriasis, severe acne, etc.) that may affect the evaluation of the test articles or increase risk to the subject.
- Subjects who have used treatments for rosacea (either topical and/or systemic) within a period of 30 days prior to admission in this study.
- Subjects who have been involved in another clinical investigation with comparable purposes within a period of 30 days prior to admission in this study.
Key Trial Info
Start Date :
May 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04898582
Start Date
May 18 2021
End Date
May 18 2021
Last Update
May 24 2021
Active Locations (1)
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1
ISPE srl
Milan, MI, Italy, 20125