Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898582
Status:
UNKNOWN
Last Update Posted:
2021-05-24
First Post:
2021-05-12
Brief Title:
Clinical Benefit of M89PB in Subjects With Rosacea Associated With Erythema and Sensitive Skin
Sponsor:
Institute of Skin and Product Evaluation Italy
Organization:
Institute of Skin and Product Evaluation Italy
Study Overview
Official Title:
A Split-face Study Assessing the Clinical Benefit Tolerability and Subject Satisfaction of M89PB in Subjects With Rosacea Associated With Erythema and Sensitive Skin
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
The test was carried out in a temperature and humidity-controlled room 24 2 C 50 10 rh
20 female subjects between 20 and 60 years old phototype I-IV according to Fitzpatrick skin type classification with sensitive skin positive reaction to stinging test and suffering from persistent centrofacial erythema of rosacea with no more than 3 papules and pustules were selected for the study
Volunteers were asked not to wash their face for at least 2 hours before performing the assessments and not to apply any products on the face for 12 hours before the basal visit
The subjects were recruited for the study if they showed a positive response to stinging test performed with the application of a solution at 15 lactic acid on the nasolabial folds
The volunteers rated the burningstingingitchingpainful sensations perceived on each nasolabial fold after 25 and 5 minutes from the application on the basis of the following scale 0no burningstingingitchingpainful sensation 1mild burningstingingitchingpainful sensation 2moderate burningstingingitchingpainful sensation 3severe burningstingingitchingpainful sensation
If the sum of the score of the two time points was 3 for each nasolabial fold the subject was considered a stinger a subject with sensitive skin and could be selected for the test
The selected subjects filled in a questionnaire on sensitive skin 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 The subjects were allowed to use their habitual foundation and makeup products on the whole face
The side of application of the product M89 Probiotic Fractions right or left side of the face was randomized among the subjects
The assignment of subject number and subsequent placement on the randomization chart were made in order of appearance at the study centre on the first day
The following evaluations were performed at the baseline after 15 days andor after 30 days of treatment
Instrumental Evaluations baseline after 15 days and after 30 days of treatment
skin hydration by Corneometer CM825
trans-epidermal water loss TEWL by Tewameter TM 300 MDD 4
skin erythema by Chromameter CR400
The measurements were performed on the cheeks on the same location at each control time
Digital images of the face of the subjects were also taken by means of Fotofinder Dermoscope Ver 20
Clinical Evaluation baseline after 15 days and after 30 days of treatment
A visual clinical evaluation of each side of the face was performed by the technician related to
erythema
desquamation
number of papules and pustules visual count
The subjects were asked to refer about skin tightness skin dryness burning itching stinging sensations perceived on each side of the face answering to the following questions
Skin tightness Do you feel skin tightness Skin dryness Does your skin feel dry Burning sensation Do you suffer from burning sensation of your skin Itching sensation Do you suffer from itching sensation of your skin Stinging sensation Do you suffer from stingingtingling sensation of your skin The parameters erythema desquamation skin tightness skin dryness burning itching and stinging were scored according to a 0-10 scale
Stinging Test baseline after 15 days and after 30 days of treatment
A solution at 15 lactic acid was applied on the nasolabial folds of each subject The volunteers rated the burningstingingitchingpain sensations perceived on each nasolabial fold after 25 and 5 minutes from the application on the basis of the following scale
0no burningstingingitchingpainful sensation
1 mild burningstingingitchingpainful sensation
2 moderate burningstingingitchingpainful sensation
3 severe burningstingingitchingpainful sensation
Standardized Skin Surface Biopsy technique SSSB after 30 days of treatment The face of the volunteers was cleaned with ether to remove traces of sebum Then a drop about 005 ml of cyanoacrylate glue was homogeneously applied to an area of 1 cm 2 at one end of a microscope slide Then the slide SSSB 1 was put against one cheek The slide was left in place until the cyanoacrylate changed in consistency and then gently removed A second SSSB SSSB 2 was performed at the same site immediately after the first The procedure was repeated on the other cheek in order to collect slides related to both the areas treated with M89 and with the habitual skin care product The SSSB 2 were analyzed with a microscope x40 and the Demodex density number of Demodex in 1 cm2 was determined for each slide
Satisfaction questionnaire after 15 days and after 30 days of treatment The subjects expressed their opinion on the efficacy and the pleasantness of the product by filling in a questionnaire referred to the side of the face treated with M89 Probiotic Fractions
20 female subjects between 20 and 60 years old phototype I-IV according to Fitzpatrick skin type classification with sensitive skin positive reaction to stinging test and suffering from persistent centrofacial erythema of rosacea with no more than 3 papules and pustules were selected for the study
Volunteers were asked not to wash their face for at least 2 hours before performing the assessments and not to apply any products on the face for 12 hours before the basal visit
The subjects were recruited for the study if they showed a positive response to stinging test performed with the application of a solution at 15 lactic acid on the nasolabial folds
The volunteers rated the burningstingingitchingpainful sensations perceived on each nasolabial fold after 25 and 5 minutes from the application on the basis of the following scale 0no burningstingingitchingpainful sensation 1mild burningstingingitchingpainful sensation 2moderate burningstingingitchingpainful sensation 3severe burningstingingitchingpainful sensation
If the sum of the score of the two time points was 3 for each nasolabial fold the subject was considered a stinger a subject with sensitive skin and could be selected for the test
The selected subjects filled in a questionnaire on sensitive skin 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 The subjects were allowed to use their habitual foundation and makeup products on the whole face
The side of application of the product M89 Probiotic Fractions right or left side of the face was randomized among the subjects
The assignment of subject number and subsequent placement on the randomization chart were made in order of appearance at the study centre on the first day
The following evaluations were performed at the baseline after 15 days andor after 30 days of treatment
Instrumental Evaluations baseline after 15 days and after 30 days of treatment
skin hydration by Corneometer CM825
trans-epidermal water loss TEWL by Tewameter TM 300 MDD 4
skin erythema by Chromameter CR400
The measurements were performed on the cheeks on the same location at each control time
Digital images of the face of the subjects were also taken by means of Fotofinder Dermoscope Ver 20
Clinical Evaluation baseline after 15 days and after 30 days of treatment
A visual clinical evaluation of each side of the face was performed by the technician related to
erythema
desquamation
number of papules and pustules visual count
The subjects were asked to refer about skin tightness skin dryness burning itching stinging sensations perceived on each side of the face answering to the following questions
Skin tightness Do you feel skin tightness Skin dryness Does your skin feel dry Burning sensation Do you suffer from burning sensation of your skin Itching sensation Do you suffer from itching sensation of your skin Stinging sensation Do you suffer from stingingtingling sensation of your skin The parameters erythema desquamation skin tightness skin dryness burning itching and stinging were scored according to a 0-10 scale
Stinging Test baseline after 15 days and after 30 days of treatment
A solution at 15 lactic acid was applied on the nasolabial folds of each subject The volunteers rated the burningstingingitchingpain sensations perceived on each nasolabial fold after 25 and 5 minutes from the application on the basis of the following scale
0no burningstingingitchingpainful sensation
1 mild burningstingingitchingpainful sensation
2 moderate burningstingingitchingpainful sensation
3 severe burningstingingitchingpainful sensation
Standardized Skin Surface Biopsy technique SSSB after 30 days of treatment The face of the volunteers was cleaned with ether to remove traces of sebum Then a drop about 005 ml of cyanoacrylate glue was homogeneously applied to an area of 1 cm 2 at one end of a microscope slide Then the slide SSSB 1 was put against one cheek The slide was left in place until the cyanoacrylate changed in consistency and then gently removed A second SSSB SSSB 2 was performed at the same site immediately after the first The procedure was repeated on the other cheek in order to collect slides related to both the areas treated with M89 and with the habitual skin care product The SSSB 2 were analyzed with a microscope x40 and the Demodex density number of Demodex in 1 cm2 was determined for each slide
Satisfaction questionnaire after 15 days and after 30 days of treatment The subjects expressed their opinion on the efficacy and the pleasantness of the product by filling in a questionnaire referred to the side of the face treated with M89 Probiotic Fractions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None