RosaceaNCT04898582
Clinical Benefit of M89PB in Subjects With Rosacea Associated With Erythema and Sensitive Skin
A study testing Mineral 89 Probiotic Fractions in people with Rosacea and Sensitive Skin, run by Institute of Skin and Product Evaluation, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rosacea, Sensitive Skin
- What is being tested?
- Mineral 89 Probiotic Fractions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 18 May 2021to 18 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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 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 burning/stinging/itching/painful sensations perceived on each nasolabial fold after 2.5 and 5 minutes from the application, on the basis of the following scale: 0=no burning/stinging/itching/painful sensation; 1=mild burning/stinging/itching/painful sensation; 2=moderate burning/stinging/itching/painful sensation; 3=severe burning/stinging/itching/painful 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 and/or 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. 2.0.
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 stinging/tingling 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 burning/stinging/itching/pain sensations perceived on each nasolabial fold after 2.5 and 5 minutes from the application, on the basis of the following scale:
0=no burning/stinging/itching/painful sensation;
- mild burning/stinging/itching/painful sensation;
- moderate burning/stinging/itching/painful sensation;
- severe burning/stinging/itching/painful 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 0.05 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.
- Conditions
- Rosacea, Sensitive Skin
- Being tested
- Mineral 89 Probiotic Fractions
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral 89 Probiotic FractionsOther
Also called Vichy
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
| Study group | Role | What they receive |
|---|---|---|
| 20 women 20-60 years old with sensitive skin and persistent centrofacial erythema of rosacea | Other | 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. Receives: Other: Mineral 89 Probiotic Fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin hydration (change of skin hydration from baseline is being assessed at 15 and 30 days)
Corneometer CM825
Corneometer CM 825 measures the skin hydration. The instrument is based on the physical principle of capacitance. The corneometric values increase with increasing hydration of the stratum corneum. The efficacy of the product in improving skin hydration is evidenced by an increase of the average corneometric values.
Measured: baseline, 15 days and 30 days of treatment
Trans-epidermal water loss - TEWL (change of TEWL from baseline is being assessed at 15 and 30 days)
Tewameter TM 300 MDD 4
Tewameter TM 300 measures the trans-epidermal water loss (TEWL) on the base of Fick's diffusion formula. TEWL values reflects the skin barrier function.
TEWL (Trans-epidermal Water Loss) expressed in g/h m2 increases with increasing impairment of skin barrier function.
Measured: baseline, 15 days and 30 days of treatment
skin erythema - a* parameter (change of skin erythema from baseline is being assessed at 15 and 30 days)
Chromameter CR400
Chromameter is a portable dual channel, reflecting colorimeter with incorporated microcomputer, liquid crystals display and Xenon light source in the measuring head. The measuring head surface is 8 mm in diameter.
The colour rating system is CIE system L*a*b*:
In the present study only the values related to the a* parameter were taken into consideration as index of skin redness/erythema.
a* value linearly increases with increasing of the intensity of the erythema.
Measured: baseline, 15 days and 30 days of treatment
Stinging test (change of stinging test clinical scores from baseline is being assessed at 15 and 30 days)
A solution at 15% lactic acid was applied on the nasolabial folds of each subject. The volunteers rated the burning/stinging/itching/pain sensations perceived on each nasolabial fold after 2.5 and 5 minutes from the application, on the basis of the following scale:
0=no burning/stinging/itching/painful sensation;
- mild burning/stinging/itching/painful sensation;
- moderate burning/stinging/itching/painful sensation;
- severe burning/stinging/itching/painful sensation.
Measured: baseline, 15 days and 30 days of treatment
Clinical evaluation (change of clinical scores from baseline is being assessed at 15 and 30 days)
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 stinging/tingling sensation of your skin?
The parameters erythema, desquamation, skin tightness, skin dryness, burning, itching and stinging were scored according to the following 0-10 scale:
0 1 2 3 4 5 6 7 8 9 10 Not at all Extremely
Measured: baseline, 15 days and 30 days of treatment
Standardized Skin Surface Biopsy (SSSB)
The face of the volunteers was cleaned with ether to remove traces of sebum. Then a drop (about 0.05 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.
Measured: 30 days of treatment
Digital Images (change is being assessed)
Digital images of the face of the subjects were also taken by means of Fotofinder Dermoscope Ver. 2.0.
Measured: baseline, 15 days and 30 days of treatment
Secondary outcomes (1)
Satisfaction Questionnaire
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.
Measured: 15 days and 30 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start18 May 2021
- Primary completion18 May 2021
- Study completion18 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Skin and Product Evaluation, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Cartigliani, Principal investigator, ISPE srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898582
- Sponsor's protocol ID
- E11UE14UE16UT17CS14CSSSB
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04898582
- Acronym / sponsor ID
- E11UE14UE16UT17CS14CSSSB
- Conditions
- Rosacea, Sensitive Skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institute of Skin and Product Evaluation, ItalyUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 18 May 2021 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 burning/stinging/itching/painful sensations perceived on each nasolabial fold after 2.5 and 5 minutes from the application, on the basis of the following scale: 0=no burning/stinging/itching/painful sensation; 1=mild burning/stinging/itching/painful sensation; 2=moderate burning/stinging/itching/painful sensation; 3=severe burning/stinging/itching/painful 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 and/or 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. 2.0.
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 stinging/tingling 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 burning/stinging/itching/pain sensations perceived on each nasolabial fold after 2.5 and 5 minutes from the application, on the basis of the following scale:
0=no burning/stinging/itching/painful sensation;
- mild burning/stinging/itching/painful sensation;
- moderate burning/stinging/itching/painful sensation;
- severe burning/stinging/itching/painful 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 0.05 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 women 20-60 years old with sensitive skin and persistent centrofacial erythema of rosacea | Other | Other: Mineral 89 Probiotic FractionsThe 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mineral 89 Probiotic FractionsAlso: VichyThe 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 | Other | 20 women 20-60 years old with sensitive skin and persistent centrofacial erythema of rosacea |
Primary outcome
skin hydration (change of skin hydration from baseline is being assessed at 15 and 30 days)
Time frame: baseline, 15 days and 30 days of treatment
Corneometer CM825 Corneometer CM 825 measures the skin hydration. The instrument is based on the physical principle of capacitance. The corneometric values increase with increasing hydration of the stratum corneum. The efficacy of the product in improving skin hydration is evidenced by an increase of the average corneometric values.
Trans-epidermal water loss - TEWL (change of TEWL from baseline is being assessed at 15 and 30 days)
Time frame: baseline, 15 days and 30 days of treatment
Tewameter TM 300 MDD 4 Tewameter TM 300 measures the trans-epidermal water loss (TEWL) on the base of Fick's diffusion formula. TEWL values reflects the skin barrier function. TEWL (Trans-epidermal Water Loss) expressed in g/h m2 increases with increasing impairment of skin barrier function.
skin erythema - a* parameter (change of skin erythema from baseline is being assessed at 15 and 30 days)
Time frame: baseline, 15 days and 30 days of treatment
Chromameter CR400 Chromameter is a portable dual channel, reflecting colorimeter with incorporated microcomputer, liquid crystals display and Xenon light source in the measuring head. The measuring head surface is 8 mm in diameter. The colour rating system is CIE system L*a*b*: In the present study only the values related to the a* parameter were taken into consideration as index of skin redness/erythema. a* value linearly increases with increasing of the intensity of the erythema.
Stinging test (change of stinging test clinical scores from baseline is being assessed at 15 and 30 days)
Time frame: baseline, 15 days and 30 days of treatment
A solution at 15% lactic acid was applied on the nasolabial folds of each subject. The volunteers rated the burning/stinging/itching/pain sensations perceived on each nasolabial fold after 2.5 and 5 minutes from the application, on the basis of the following scale: 0=no burning/stinging/itching/painful sensation; 1. mild burning/stinging/itching/painful sensation; 2. moderate burning/stinging/itching/painful sensation; 3. severe burning/stinging/itching/painful sensation.
Clinical evaluation (change of clinical scores from baseline is being assessed at 15 and 30 days)
Time frame: baseline, 15 days and 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 stinging/tingling sensation of your skin? The parameters erythema, desquamation, skin tightness, skin dryness, burning, itching and stinging were scored according to the following 0-10 scale: 0 1 2 3 4 5 6 7 8 9 10 Not at all Extremely
Standardized Skin Surface Biopsy (SSSB)
Time frame: 30 days of treatment
The face of the volunteers was cleaned with ether to remove traces of sebum. Then a drop (about 0.05 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.
Digital Images (change is being assessed)
Time frame: baseline, 15 days and 30 days of treatment
Digital images of the face of the subjects were also taken by means of Fotofinder Dermoscope Ver. 2.0.
1 secondary outcome
Satisfaction Questionnaire
Time frame: 15 days and 30 days of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Cartigliani principal investigator
ISPE srl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mineral 89 Probiotic Fractions in people with Rosacea and Sensitive Skin, run by Institute of Skin and Product Evaluation, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin hydration (change of skin hydration from baseline is being assessed at 15 and 30 days) (time frame: baseline, 15 days and 30 days of treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.