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| Name | Class |
|---|---|
| Eurofins | INDUSTRY |
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The goal of this interventional, confirmatory and post market study is to evaluate the efficacy and clinical performance of Crystal Peel in adults suffering mild facial acne vulgaris. The principal and secondary aims are:
The primary endpoint of the study will be an objective counting of the acne lesions performed on every visit.
Total lesions will be defined as the sum of inflammatory lesions (papules and pustules), non-inflammatory lesions (whiteheads and blackheads) and other acne lesions (nodules).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crystal Peel | Other | 2.5 ml of Crystal peel applied up to 3 coats and performed 3 times in the study (i.e: at Day 15, Day 36 and Day 57. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crystal Peel | Device | 3 applications performed by a dermatologist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the Change From Baseline of Count Lesions on Each Visit to Evaluate the Efficacy and Clinical Performance of Crystal Peel for the Treatment of Acne. | Lesion counting using both visual observation and palpation. Total lesions (front, 2 cheeks, the chin above the jaw line (excluding the nose)) will be defined as the sum of inflammatory lesions (papules, pustules), non-inflammatory lesions (whiteheads and blackheads) and other acne lesions (nodules). | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
| Measure | Description | Time Frame |
|---|---|---|
| Acne Investigator Global Assessment (IGA) Score | Investigator's global assessment of acne condition improvement at Day 78 (last protocol visit). The score range is -1 to 3, with higher scores denoting better outcomes, better acne condition improvement from baseline. Score ranges details: -1 (worse), 0 (no improvement), 1 (good improvement), 2 (very good improvement) on Day 78 (last protocol visit). |
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Inclusion Criteria:
Female subject not in childbearing status (tubal ligation, hysterectomy, bilateral oophorectomy), or Female subjects of childbearing potential who, in the opinion of the investigator, are using a reliable method of contraception (pill or contraceptive patch, IUD, implant or vaginal ring,condoms) for at least one month prior to the screening visit. Subject willing to continue using contraception during the study and one month after the end of the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beata IMKO-WALCZUK, Dr | Eurofins Dermscan Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Dermscan Poland | Gdansk | Poland |
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Of 42 enrolled patients, 33 met study eligibility criteria and were included to Crystal Peel treatment and 9 did not met inclusion criteria number 6 (i.e: low number of acne lesions).
Patients were recruited based on dermatologist referral in a single-site between January 2023 and March 2023.
The first patient was enrolled on January 23, 2023 and the last patient was enrolled on March 3, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Crystal Peel | Patients received 2.5 ml of Crystal peel topically applied up to 3 coats and performed 3 times in the study (i.e: at Day 15, Day 36 and Day 57). Crystal Peel: 3 applications performed by a dermatologist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Crystal Peel | Patients received 2.5 ml of Crystal peel topically applied up to 3 coats and performed 3 times in the study (i.e: at Day 15, Day 36 and Day 57). Crystal Peel: 3 applications performed by a dermatologist. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparison of the Change From Baseline of Count Lesions on Each Visit to Evaluate the Efficacy and Clinical Performance of Crystal Peel for the Treatment of Acne. | Lesion counting using both visual observation and palpation. Total lesions (front, 2 cheeks, the chin above the jaw line (excluding the nose)) will be defined as the sum of inflammatory lesions (papules, pustules), non-inflammatory lesions (whiteheads and blackheads) and other acne lesions (nodules). | Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigation plan. | Posted | Count of Units | Lesions count at each protocol visit | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). | Lesions count at each protocol visit | Lesions count at each protocol visit |
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78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Crystal Peel | 2.5 ml of Crystal peel applied up to 3 coats and performed 3 times in the study (i.e: at Day 15, Day 36 and Day 57). Crystal Peel: 3 applications performed by a dermatologist. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Bayo Rodriguez | Dermosciences France | 638966321 | 0033 | clinicaltrials@dermaceutic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2022 | Oct 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D019066 | Facies |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| At Visit 5/Day 78. |
| Acne Patient Global Assessment (PGA) Scale | Patient's global assessment of acne condition improvement at Day 78 (last protocol visit). The score range is -1 to 3, with higher scores denoting better outcomes, better acne condition improvement from baseline. Score ranges details: -1 (worse), 0 (no improvement), 1 (good improvement), 2 (very good improvement) on Day 78 (last protocol visit). | At Visit 5/Day 78. |
| Local and Overall Tolerance of the Crystal Peel. | At the end of the study, the local tolerance on the skin of the product has been assessed during the clinical examination by the investigator by the "Local tolerance scale" (from 0 to 3, where higher scores mean better outcome) according to the following scores: 0= bad tolerance; 1= moderate tolerance; 2= good tolerance and 3= very good tolerance. | At Visit 5/Day 78). |
| Subject's Satisfaction Questionnaire | Count and percentage of subjects who answered satisfactorily to the 17-item questionnaire that measured patients' satisfaction after use of Crystal Peel in treating acne at Day 78 (final protocol visit). | At Visit 5/Day 78. |
| Number of Adverse Events | Collection of adverse events by the investigator. Please refer to Adverse Events tables for more details. | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
| Comparison of Change From Baseline of Conspicuous Number of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous number is defined as the number of distinct elements in the segmentation. A decrease of the conspicuous number of pores results in a decrease of the number of pores that are detected by the algorithm. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores. | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
| Comparison of Change From Baseline of Conspicuous Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous area is defined as the total number of pixels in the segmentation (total surface of detected pores). A decrease of the conspicuous area results in a decrease of the total surface occupied by detected pores. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores. | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
| Comparison of Change From Baseline of Conspicuous Relative Area (Density) of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm.The relative area is defined as the area of segmentation divided by total area of the region of interest. A decrease of conspicuous relative area results in a decrease of the detected pores conspicuous density. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores. | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
| Comparison of Change From Baseline of Conspicuous Depth of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous depth is defined as the difference of intensity between detected pores segmentation and surrounding segmentation. It is an average value over the whole region of interest. A decrease of conspicuous depth results in a decrease of detected pores visibility. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores. | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
| Comparison of Change From Baseline of Average Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The average area is defined as the area of segmentation divided by the number of distinct elements in the segmentation. It represents the average area of one detected pore. A decrease of the average area results in a decrease of the average size of detected pores or remaining detected pores if number decreases. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores. | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
| Comparison of Change From Baseline of Conspicuous Volume of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous volume is defined as the multiplication of conspicuous area and conspicuous depth. A decrease of conspicuous volume results in a decrease of detected pores visibility. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores. | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
| Comparison of Change From Baseline of Conspicuous Area of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device. | Profiles images with parallel polarization will be analyzed by colorface device. A region of interest is delimited on the cheek of each subject at baseline and it is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous total area is defined as the number of pixels in segmentation of detected line marks. A decrease of conspicuous area results in a decrease of the total size of cheek line marks. There is an improvement of line marks if and only if one of the following parameters is decreasing and others ones are stable (no statistically significance) or decreasing: conspicuous area (unit=number of pixels), conspicuous length (unit=number of pixels), conspicuous depth (unit=arbitrary unit) and conspicuous volume of line marks (unit=arbitrary unit). | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
| Comparison of Change From Baseline of Conspicuous Depth of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device. | Profiles images with parallel polarization will be analyzed by Colorface device. A region of interest is delimited on the cheek of each subject at baseline and it is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The average conspicuous depth is defined as the difference of intensity between segmentation and surrounding segmentation. A decrease of conspicuous depth results in a decrease of cheek line marks visibility. There is an improvement of line marks if and only if one of the following parameters is decreasing and others ones are stable (no statistically significance) or decreasing: conspicuous area (unit=number of pixels), conspicuous length (unit=number of pixels), conspicuous depth (unit=arbitrary unit) and conspicuous volume of line marks (unit=arbitrary unit). | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
| Comparison of Change From Baseline of Conspicuous Length of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device. | Profiles images with parallel polarization will be analyzed by colorface device. A region of interest is delimited on the cheek of each subject at baseline and it is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous length is defined as the total number of pixels in the morphological skeleton of segmentation. The morphological skeleton is defined as the central element of unit width of segmentation of detected line marks. A decrease of conspicuous length results in a decrease of the cumulated length of detected cheek line marks. There is an improvement of line marks if and only if one of the following parameters is decreasing and others ones are stable (no statistically significance) or decreasing: conspicuous area (unit=number of pixels), conspicuous length (unit=number of pixels), conspicuous depth (unit=arbitrary unit) and conspicuous volume of line marks (unit=arbitrary unit). | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
| Comparison of Change From Baseline of Conspicuous Volume of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device. | Profiles images with parallel polarization will be analyzed by colorface device. A region of interest is delimited on the cheek of each subject at baseline and it is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous volume is defined as the multiplication of conspicuous area and conspicuous depth. A decrease of conspicuous volume results in a decrease of cheek line marks visibility. There is an improvement of line marks if and only if one of the following parameters is decreasing and others ones are stable (no statistically significance) or decreasing: conspicuous area (unit=number of pixels), conspicuous length (unit=number of pixels), conspicuous depth (unit=arbitrary unit) and conspicuous volume of line marks (unit=arbitrary unit). | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fitzpatrick skin phototype | Fitzpatrick skin phototypes (from I to IV) used to characterize studied population. For guidance on Fitzpatrick skin phototypes, (Rünger 2019). I: always burns, never tans. Pale white color of unexposed skin. II: always burns, then tans. White color of unexposed skin. III: sometimes burns, can tan without prior burn. White color of unexposed skin. IV: usually does not burn, tans easily and deeply. White to light brown color of unexposed skin. | Number | participants |
|
Patients received 2.5 ml of Crystal peel topically applied up to 3 coats and performed 3 times in the study (i.e: at Day 15, Day 36 and Day 57).
Crystal Peel: 3 applications performed by a dermatologist.
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| Secondary | Acne Investigator Global Assessment (IGA) Score | Investigator's global assessment of acne condition improvement at Day 78 (last protocol visit). The score range is -1 to 3, with higher scores denoting better outcomes, better acne condition improvement from baseline. Score ranges details: -1 (worse), 0 (no improvement), 1 (good improvement), 2 (very good improvement) on Day 78 (last protocol visit). | Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan). | Posted | Mean | Standard Deviation | score on a scale | At Visit 5/Day 78. |
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| Secondary | Acne Patient Global Assessment (PGA) Scale | Patient's global assessment of acne condition improvement at Day 78 (last protocol visit). The score range is -1 to 3, with higher scores denoting better outcomes, better acne condition improvement from baseline. Score ranges details: -1 (worse), 0 (no improvement), 1 (good improvement), 2 (very good improvement) on Day 78 (last protocol visit). | Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan). | Posted | Mean | Standard Deviation | score on a scale | At Visit 5/Day 78. |
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| Secondary | Local and Overall Tolerance of the Crystal Peel. | At the end of the study, the local tolerance on the skin of the product has been assessed during the clinical examination by the investigator by the "Local tolerance scale" (from 0 to 3, where higher scores mean better outcome) according to the following scores: 0= bad tolerance; 1= moderate tolerance; 2= good tolerance and 3= very good tolerance. | Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan). | Posted | Count of Participants | Participants | At Visit 5/Day 78). |
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| Secondary | Subject's Satisfaction Questionnaire | Count and percentage of subjects who answered satisfactorily to the 17-item questionnaire that measured patients' satisfaction after use of Crystal Peel in treating acne at Day 78 (final protocol visit). | Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigation plan. | Posted | Count of Participants | Participants | At Visit 5/Day 78. |
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| Secondary | Number of Adverse Events | Collection of adverse events by the investigator. Please refer to Adverse Events tables for more details. | Safety population: any subject having used the investigational device. 33 patients have been analyzed. | Posted | Number | adverse events | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). | adverse events | adverse events |
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| Secondary | Comparison of Change From Baseline of Conspicuous Number of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous number is defined as the number of distinct elements in the segmentation. A decrease of the conspicuous number of pores results in a decrease of the number of pores that are detected by the algorithm. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores. | Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan). | Posted | Mean | Standard Deviation | number of detected pores | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
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| Secondary | Comparison of Change From Baseline of Conspicuous Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous area is defined as the total number of pixels in the segmentation (total surface of detected pores). A decrease of the conspicuous area results in a decrease of the total surface occupied by detected pores. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores. | Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan). | Posted | Mean | Standard Deviation | total number of pixels | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
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| Secondary | Comparison of Change From Baseline of Conspicuous Relative Area (Density) of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm.The relative area is defined as the area of segmentation divided by total area of the region of interest. A decrease of conspicuous relative area results in a decrease of the detected pores conspicuous density. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores. | Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan). | Posted | Mean | Standard Deviation | percentage | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
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| Secondary | Comparison of Change From Baseline of Conspicuous Depth of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous depth is defined as the difference of intensity between detected pores segmentation and surrounding segmentation. It is an average value over the whole region of interest. A decrease of conspicuous depth results in a decrease of detected pores visibility. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores. | Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan). | Posted | Mean | Standard Deviation | arbitrary unit | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
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| Secondary | Comparison of Change From Baseline of Average Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The average area is defined as the area of segmentation divided by the number of distinct elements in the segmentation. It represents the average area of one detected pore. A decrease of the average area results in a decrease of the average size of detected pores or remaining detected pores if number decreases. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores. | Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan). | Posted | Mean | Standard Deviation | number of pixels | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
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| Secondary | Comparison of Change From Baseline of Conspicuous Volume of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous volume is defined as the multiplication of conspicuous area and conspicuous depth. A decrease of conspicuous volume results in a decrease of detected pores visibility. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores. | Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan). | Posted | Mean | Standard Deviation | arbitrary unit | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
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| Secondary | Comparison of Change From Baseline of Conspicuous Area of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device. | Profiles images with parallel polarization will be analyzed by colorface device. A region of interest is delimited on the cheek of each subject at baseline and it is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous total area is defined as the number of pixels in segmentation of detected line marks. A decrease of conspicuous area results in a decrease of the total size of cheek line marks. There is an improvement of line marks if and only if one of the following parameters is decreasing and others ones are stable (no statistically significance) or decreasing: conspicuous area (unit=number of pixels), conspicuous length (unit=number of pixels), conspicuous depth (unit=arbitrary unit) and conspicuous volume of line marks (unit=arbitrary unit). | Intent-to-treat (ITT) population: any subject included in the study with at least a post-basal value. | Posted | Mean | Standard Deviation | number of pixels | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
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| Secondary | Comparison of Change From Baseline of Conspicuous Depth of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device. | Profiles images with parallel polarization will be analyzed by Colorface device. A region of interest is delimited on the cheek of each subject at baseline and it is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The average conspicuous depth is defined as the difference of intensity between segmentation and surrounding segmentation. A decrease of conspicuous depth results in a decrease of cheek line marks visibility. There is an improvement of line marks if and only if one of the following parameters is decreasing and others ones are stable (no statistically significance) or decreasing: conspicuous area (unit=number of pixels), conspicuous length (unit=number of pixels), conspicuous depth (unit=arbitrary unit) and conspicuous volume of line marks (unit=arbitrary unit). | Intent-to-treat (ITT) population: any subject included in the study with at least a post-basal value. | Posted | Mean | Standard Deviation | arbitrary unit | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
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| Secondary | Comparison of Change From Baseline of Conspicuous Length of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device. | Profiles images with parallel polarization will be analyzed by colorface device. A region of interest is delimited on the cheek of each subject at baseline and it is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous length is defined as the total number of pixels in the morphological skeleton of segmentation. The morphological skeleton is defined as the central element of unit width of segmentation of detected line marks. A decrease of conspicuous length results in a decrease of the cumulated length of detected cheek line marks. There is an improvement of line marks if and only if one of the following parameters is decreasing and others ones are stable (no statistically significance) or decreasing: conspicuous area (unit=number of pixels), conspicuous length (unit=number of pixels), conspicuous depth (unit=arbitrary unit) and conspicuous volume of line marks (unit=arbitrary unit). | Intent-to-treat (ITT) population: any subject included in the study with at least a post-basal value. | Posted | Mean | Standard Deviation | number of pixels | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
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| Secondary | Comparison of Change From Baseline of Conspicuous Volume of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device. | Profiles images with parallel polarization will be analyzed by colorface device. A region of interest is delimited on the cheek of each subject at baseline and it is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous volume is defined as the multiplication of conspicuous area and conspicuous depth. A decrease of conspicuous volume results in a decrease of cheek line marks visibility. There is an improvement of line marks if and only if one of the following parameters is decreasing and others ones are stable (no statistically significance) or decreasing: conspicuous area (unit=number of pixels), conspicuous length (unit=number of pixels), conspicuous depth (unit=arbitrary unit) and conspicuous volume of line marks (unit=arbitrary unit). | Intent-to-treat (ITT) population: any subject included in the study with at least a post-basal value. | Posted | Mean | Standard Deviation | arbitrary unit | At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). |
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| 0 |
| 33 |
| 0 |
| 33 |
| 33 |
| 33 |
| Desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dryness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sensation of coolness after peel application | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin tightness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Stinging | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Superficial skin whitening after peel application | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Tingling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Warm sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Earache | Ear and labyrinth disorders | Systematic Assessment |
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| Flu | Infections and infestations | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Menstrual pain | Endocrine disorders | Systematic Assessment |
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| Oedema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sinus pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sore thorat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Stomachache | Gastrointestinal disorders | Systematic Assessment |
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| Toothache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Increase in acne lesions | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Inflammatory lump on right cheek after insect bite | Skin and subcutaneous tissue disorders | Systematic Assessment |
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There is an agreement between Dermosciences France and the Clinical Research Organization who contracted the PI. Clinical Research Organization expressly agreed that any results communication must be submitted in advanced to Dermosciences France for approval.
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Bad tolerance |
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| Pores are tightened and less visible |
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| Skin texture is improved |
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| The skin is matified |
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| The skin is clearer |
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| Satisfactory effectiveness of this treatment |
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| This treatment is of high performance |
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| I am delighted with the results obtained to date |
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| The treatment met my needs |
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| The treatment is not restrictive |
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| Compared to other treatments, this one is more effective |
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| Thanks to this treatment, I feel better in my skin |
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| I would like to continue this treatment |
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| I will be interested in renewing this treatment with a practitioner |
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| I will advise someone else to use this treatment |
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| % of patients with positive answers |
| 94 |
| 2-Sided |
| 95 |
| 80 |
| 98 |
| Other |
| Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne. | % of patients with positive answers | 88 | 2-Sided | 95 | 73 | 95 | Other |
| Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne. | % of patients with positive answers | 85 | 2-Sided | 95 | 68 | 93 | Other |
| Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne. | % of patients with positive answers | 91 | 2-Sided | 95 | 77 | 97 | Other |
| Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne. | % of patients with positive answers | 85 | 2-Sided | 95 | 69 | 93 | Other |
| Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne. | % of patients with positive answers | 78 | 2-Sided | 95 | 61 | 89 | Other |
| Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne. | % of patients with positive answers | 79 | 2-Sided | 95 | 62 | 89 | Other |
| Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne. | % of patients with positive answers | 76 | 2-Sided | 95 | 59 | 87 | Other |
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| Adverse events related to studied product : mild |
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| Adverse events related to studied product : moderate |
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| Adverse events related to studied product : severe |
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| Conspicuous number of detected pores at Day 57 |
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| Conspicuous number of detected pores at Day 78 |
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Comparison of change from baseline of conspicuous number of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device. |
| t-test, 2 sided |
| 0.010 |
If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. |
| Mean Difference (Final Values) |
| -30.85 |
| Standard Deviation |
| 63.92 |
| 2-Sided |
| Other |
| Comparison of change from baseline of conspicuous number of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device. | t-test, 2 sided | <0.004 | If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. | Mean Difference (Final Values) | -41.69 | Standard Deviation | 73.69 | 2-Sided | Other |
| Comparison of change from baseline of conspicuous number of detected pores at day 78 to evaluate the improvement of pores assessed by Colorface device. | t-test, 2 sided | 0.013 | If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. | Mean Difference (Final Values) | -29.13 | Standard Deviation | 61.45 | 2-Sided | Other |
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| conspicuous area of detected pores at Day 57 |
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| conspicuous area of detected pores at Day 78 |
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Comparison of change from baseline of conspicuous area of detected pores at day 36 to evaluate the improvement of pores assessed by Colorface device. |
| t-test, 2 sided |
| 0.025 |
If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. |
| Mean Difference (Final Values) |
| -1754.88 |
| Standard Deviation |
| 4220.25 |
| 2-Sided |
| Other |
| Comparison of change from baseline of conspicuous area of detected pores at day 57 to evaluate the improvement of pores assessed by Colorface device. | t-test, 2 sided | 0.004 | If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. | Mean Difference (Final Values) | -2763.41 | Standard Deviation | 4965.84 | 2-Sided | Other |
| Comparison of change from baseline of conspicuous area of detected pores at day 78 to evaluate the improvement of pores assessed by Colorface device. | t-test, 2 sided | 0.021 | If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. | Mean Difference (Final Values) | -1742.41 | Standard Deviation | 3974.21 | 2-Sided | Other |
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| Conspicuous relative area (density) of detected pores at Day 57 |
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| Conspicuous relative area (density) of detected pores at Day 78 |
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|
Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device. |
| t-test, 2 sided |
| 0.029 |
If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. |
| Mean Difference (Final Values) |
| -0.68 |
| Standard Deviation |
| 1.68 |
| 2-Sided |
| Other |
| Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device. | t-test, 2 sided | 0.006 | If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. | Mean Difference (Final Values) | -1.07 | Standard Deviation | 2.01 | 2-Sided | Other |
| Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device. | t-test, 2 sided | 0.037 | If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. | Mean Difference (Net) | -0.65 | Standard Deviation | 1.67 | 2-Sided | Other |
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| Conspicuous depth of detected pores at Day 57 |
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| Conspicuous depth of detected poresat Day 78 |
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Comparison of change from baseline of conspicuous depth of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device. |
| Wilcoxon (Mann-Whitney) |
| 0.348 |
If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. |
| Mean Difference (Final Values) |
| -0.14 |
| Standard Deviation |
| 0.71 |
| 2-Sided |
| Other |
| Comparison of change from baseline of conspicuous depth of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device. | Wilcoxon (Mann-Whitney) | 0.091 | If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. | Mean Difference (Final Values) | -0.27 | Standard Deviation | 0.75 | 2-Sided | Other |
| Comparison of change from baseline of conspicuous depth of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device. | Wilcoxon (Mann-Whitney) | 0.190 | If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. | Mean Difference (Final Values) | -0.12 | Standard Deviation | 0.65 | 2-Sided | Other |
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| Average area of detected pores at Day 57 |
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| Average area of detected pores at Day 78 |
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Comparison of change from baseline of average area of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device. |
| t-test, 2 sided |
| 0.281 |
If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. |
| Mean Difference (Final Values) |
| -0.64 |
| Standard Deviation |
| 3.28 |
| 2-Sided |
| Other |
| Comparison of change from baseline of average area of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device. | t-test, 2 sided | 0.060 | If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. | Mean Difference (Final Values) | -1.57 | Standard Deviation | 4.46 | 2-Sided | Other |
| Comparison of change from baseline of average area of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device. | t-test, 2 sided | 0.209 | If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. | Mean Difference (Final Values) | -0.87 | Standard Deviation | 3.80 | 2-Sided | Other |
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| Conspicuous volume of detected pores at Day 57 |
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| Conspicuous volume of detected pores at Day 78 |
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|
Comparison of change from baseline of conspicuous volume of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device. |
| t-test, 2 sided |
| 0.073 |
| Mean Difference (Final Values) |
| -14447.02 |
| Standard Deviation |
| 44054.48 |
| 2-Sided |
| Other |
| Comparison of change from baseline of conspicuous volume of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device. | t-test, 2 sided | 0.008 | Mean Difference (Final Values) | -25315.34 | Standard Deviation | 49884.67 | 2-Sided | Other | If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. |
| Comparison of change from baseline of conspicuous volume of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device. | t-test, 2 sided | 0.071 | If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter. | Mean Difference (Final Values) | -13287.34 | Standard Deviation | 39615.92 | 2-Sided | Other |
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| Conspicuous area of line marks at Day 57 |
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| Conspicuous area of line marks at Day 78 |
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|
Comparison of change from baseline of conspicuous area of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device. |
| Wilcoxon (Mann-Whitney) |
| 0.041 |
If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter. |
| Mean Difference (Final Values) |
| -7230.81 |
| Standard Deviation |
| 17547.60 |
| 2-Sided |
| Other |
| Comparison of change from baseline of conspicuous area of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device. | Wilcoxon (Mann-Whitney) | 0.007 | If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter. | Mean Difference (Final Values) | -9086.26 | Standard Deviation | 18306.64 | 2-Sided | Other |
| Comparison of change from baseline of conspicuous area of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device. | Wilcoxon (Mann-Whitney) | 0.931 | If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter. | Mean Difference (Final Values) | 64.71 | Standard Deviation | 14542.17 | 2-Sided | Other |
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| Conspicuous depth of line marks at Day 57 |
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| Conspicuous depth of line marks at Day 78 |
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Comparison of change from baseline of conspicuous depth of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device. |
| t-test, 2 sided |
| 0.035 |
If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter. |
| Mean Difference (Final Values) |
| -0.32 |
| Standard Deviation |
| 0.80 |
| 2-Sided |
| Other |
| Comparison of change from baseline of conspicuous depth of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device. | t-test, 2 sided | 0.036 | If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter. | Mean Difference (Final Values) | -0.34 | Standard Deviation | 0.86 | 2-Sided | Other |
| Comparison of change from baseline of conspicuous depth of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device. | t-test, 2 sided | 0.784 | If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter. | Mean Difference (Final Values) | 0.04 | Standard Deviation | 0.77 | 2-Sided | Other |
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| Conspicuous length of line marks at Day 57 |
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| Conspicuous length of line marks at Day 78 |
|
Comparison of change from baseline of conspicuous length of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device. |
| Wilcoxon (Mann-Whitney) |
| 0.074 |
If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter. |
| Mean Difference (Final Values) |
| -2315.00 |
| Standard Deviation |
| 6197.86 |
| 2-Sided |
| Other |
| Comparison of change from baseline of conspicuous length of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device. | Wilcoxon (Mann-Whitney) | 0.007 | If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter. | Mean Difference (Final Values) | -2700.55 | Standard Deviation | 5962.30 | 2-Sided | Other |
| Comparison of change from baseline of conspicuous length of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device. | Wilcoxon (Mann-Whitney) | 0.779 | If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter. | Mean Difference (Final Values) | 430.65 | Standard Deviation | 5021.20 | 2-Sided | Other |
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| Conspicuous volume of line marks at Day 57 |
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| Conspicuous volume of line marks at Day 78 |
|
|
Comparison of change from baseline of conspicuous volume of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device. |
| Wilcoxon (Mann-Whitney) |
| 0.054 |
If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter. |
| Mean Difference (Final Values) |
| -73517.86 |
| Standard Deviation |
| 197224.85 |
| 2-Sided |
| Other |
| Comparison of change from baseline of conspicuous volume of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device. | Wilcoxon (Mann-Whitney) | 0.008 | If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter. | Mean Difference (Final Values) | -90424.89 | Standard Deviation | 198264.20 | 2-Sided | Other |
| Comparison of change from baseline of conspicuous volume of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device. | t-test, 2 sided | 0.779 | Mean Difference (Final Values) | 1314.03 | 2-Sided | Other |