Acne Vulgaris
Conditions
Keywords
acne, facial, crystal peel, salicylic acid, chemical peel
Brief summary
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: * Principal aim: to evaluate the efficacy and clinical performance of Crystal Peel, a salicylic-based peel, for the treatment of acne by lesions counting (front, 2 cheeks, the chin above the jaw line (excluding the nose)) using both visual observation and palpation. * Secondary aims: pores and texture analysis, visual effect (Standardized anonymized photographs, investigator global assessment, patient global assessment, local and overall tolerance of the Crystal Peel, subject's self-evaluation and potential adverse events collection. The primary endpoint of the study will be an objective counting of the acne lesions performed on every visit.
Detailed description
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).
Interventions
DEVICECrystal Peel
3 applications performed by a dermatologist.
Sponsors
Eurofins
Dermosciences France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Healthy subjects 2. Gender: female and/or male. 3. Age: 18 - 45 4. Phototype I to IV according Fitzpatrick scale. 5. Healthy subject with normal physical examination results and a medical history compatible with the requirements of the study. 6. A healthy male or female subject with a medical diagnosis of mild to moderate facial acne vulgaris defined by at least 6 (six) inflammatory lesions, 12 (twelve) non-inflammatory lesions and no more than 2 (two) nodules (the nose is excluded for lesion count purposes). 7. Subject declares to avoid exposure to UV radiation (tanning booths, phototherapy and sun) on the face for at least three months prior to the selection visit and agrees to avoid it throughout the study. 8. Subject agrees not to apply any cosmetic, medical or aesthetic treatments outside the study protocol on the face for the duration of the study. 9. For female subjects: 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
1. Pregnant or nursing woman or planning a pregnancy during the study. 2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship. 3. Subject in a social or sanitary establishment. 4. Subject participating to another clinical research or being in an exclusion period for a previous study. 5. Intensive exposure to sunlight or UV-rays within the previous 3 months and foreseen during the study. 6. Subject with any skin or systemic disease (acute and/or chronic), in the previous year, likely to interfere with the measured parameters or to put the subject to an undue risk. 7. Subject having history of allergy or hypersensitivity to one of the components of the tested device. 8. Subject receiving any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject to undue risk. 9. Subjects on topical or oral treatments (such as Benzoyl Peroxide, Retinoic Acid, isotretinoin) that did not stop the treatment 30 days before their first peel (risk of over-peeling). 10. Subjects with known salicylism or related medical indications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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). | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acne Patient Global Assessment (PGA) Scale | At Visit 5/Day 78. | 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). |
| Local and Overall Tolerance of the Crystal Peel. | At Visit 5/Day 78). | 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. |
| Subject's Satisfaction Questionnaire | At Visit 5/Day 78. | 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). |
| Number of 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). | Collection of adverse events by the investigator. Please refer to Adverse Events tables for more details. |
| Comparison of Change From Baseline of Conspicuous Number of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | 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). | 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. |
| Comparison of Change From Baseline of Conspicuous Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | 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). | 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. |
| 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. | 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). | 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. |
| Acne Investigator Global Assessment (IGA) Score | At Visit 5/Day 78. | 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). |
| Comparison of Change From Baseline of Average Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | 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). | 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. |
| Comparison of Change From Baseline of Conspicuous Volume of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | 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). | 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. |
| 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. | 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). | 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). |
| 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. | 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). | 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). |
| 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. | 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). | 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). |
| 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. | 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). | 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). |
| Comparison of Change From Baseline of Conspicuous Depth of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | 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). | 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. |
Countries
Poland
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Crystal Peel | — |
|---|---|---|
| Age, Continuous | 24 years STANDARD_DEVIATION 5 | — |
| Fitzpatrick skin phototype Skin phototype I | 0 participants | — |
| Fitzpatrick skin phototype Skin phototype II | 26 participants | — |
| Fitzpatrick skin phototype Skin phototype III | 7 participants | — |
| Fitzpatrick skin phototype Skin phototype IV | 0 participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Poland | 33 participants | — |
| Sex: Female, Male Female | 27 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 33 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
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).
Time frame: 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).
Population: Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigation plan.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Crystal Peel | 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. | Lesions count at Day 0 | 943 Lesions count at each protocol visit |
| Crystal Peel | 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. | Lesions count at Day 15 | 647 Lesions count at each protocol visit |
| Crystal Peel | 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. | Lesions count at Day 36 | 457 Lesions count at each protocol visit |
| Crystal Peel | 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. | Lesions count at Day 57 | 407 Lesions count at each protocol visit |
| Crystal Peel | 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. | Lesions count at Day 78 | 463 Lesions count at each protocol visit |
p-value: <0.000195% CI: [-17.31, -11.84]ANCOVA
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).
Time frame: At Visit 5/Day 78.
Population: Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystal Peel | Acne Investigator Global Assessment (IGA) Score | 1.85 score on a scale | Standard Deviation 0.87 |
95% CI: [1.54, 2.16]
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).
Time frame: At Visit 5/Day 78.
Population: Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crystal Peel | Acne Patient Global Assessment (PGA) Scale | 1.82 score on a scale | Standard Deviation 1.07 |
95% CI: [1.44, 2.2]
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.
Time frame: 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).
Population: Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystal Peel | Comparison of Change From Baseline of Average Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Average area of detected pores at Day 0 | 51.39 number of pixels | Standard Deviation 9.44 |
| Crystal Peel | Comparison of Change From Baseline of Average Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Average area of detected pores at Day 15 | 49.70 number of pixels | Standard Deviation 8.93 |
| Crystal Peel | Comparison of Change From Baseline of Average Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Average area of detected pores at Day 36 | 50.76 number of pixels | Standard Deviation 9.34 |
| Crystal Peel | Comparison of Change From Baseline of Average Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Average area of detected pores at Day 57 | 49.75 number of pixels | Standard Deviation 8.37 |
| Crystal Peel | Comparison of Change From Baseline of Average Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Average area of detected pores at Day 78 | 50.44 number of pixels | Standard Deviation 8.87 |
Comparison: Comparison of change from baseline of average area of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.011t-test, 2 sided
Comparison: Comparison of change from baseline of average area of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.281t-test, 2 sided
Comparison: Comparison of change from baseline of average area of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.06t-test, 2 sided
Comparison: Comparison of change from baseline of average area of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.209t-test, 2 sided
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.
Time frame: 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).
Population: Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | conspicuous area of detected pores at Day 0 | 19088.48 total number of pixels | Standard Deviation 9179.66 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | conspicuous area of detected pores at Day 15 | 16256.09 total number of pixels | Standard Deviation 9179.12 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | conspicuous area of detected pores at Day 36 | 17333.61 total number of pixels | Standard Deviation 8895.27 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | conspicuous area of detected pores at Day 57 | 16109.97 total number of pixels | Standard Deviation 7666.83 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | conspicuous area of detected pores at Day 78 | 17130.97 total number of pixels | Standard Deviation 8546.22 |
Comparison: Comparison of change from baseline of conspicuous area of detected pores at day 15 to evaluate the improvement of pores assessed by Colorface device.p-value: <0.0001t-test, 2 sided
Comparison: Comparison of change from baseline of conspicuous area of detected pores at day 36 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.025t-test, 2 sided
Comparison: Comparison of change from baseline of conspicuous area of detected pores at day 57 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.004t-test, 2 sided
Comparison: Comparison of change from baseline of conspicuous area of detected pores at day 78 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.021t-test, 2 sided
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).
Time frame: 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).
Population: Intent-to-treat (ITT) population: any subject included in the study with at least a post-basal value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystal Peel | 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. | Conspicuous area of line marks at Day 0 | 44845.94 number of pixels | Standard Deviation 32444.07 |
| Crystal Peel | 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. | Conspicuous area of line marks at Day 15 | 37327.69 number of pixels | Standard Deviation 27992.85 |
| Crystal Peel | 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. | Conspicuous area of line marks at Day 36 | 37615.13 number of pixels | Standard Deviation 24073.14 |
| Crystal Peel | 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. | Conspicuous area of line marks at Day 57 | 34126.74 number of pixels | Standard Deviation 21031.09 |
| Crystal Peel | 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. | Conspicuous area of line marks at Day 78 | 43277.71 number of pixels | Standard Deviation 31379 |
Comparison: Comparison of change from baseline of conspicuous area of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.p-value: 0.003Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.041Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.007Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.931Wilcoxon (Mann-Whitney)
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.
Time frame: 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).
Population: Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Depth of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Conspicuous depth of detected pores at Day 0 | 7.12 arbitrary unit | Standard Deviation 0.98 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Depth of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Conspicuous depth of detected pores at Day 15 | 6.73 arbitrary unit | Standard Deviation 1.03 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Depth of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Conspicuous depth of detected pores at Day 36 | 6.98 arbitrary unit | Standard Deviation 1.1 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Depth of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Conspicuous depth of detected pores at Day 57 | 6.85 arbitrary unit | Standard Deviation 1.05 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Depth of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Conspicuous depth of detected poresat Day 78 | 7.01 arbitrary unit | Standard Deviation 1.23 |
Comparison: Comparison of change from baseline of conspicuous depth of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.091Wilcoxon (Mann-Whitney)
Comparison: Comparison of change from baseline of conspicuous depth of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.001t-test, 2 sided
Comparison: Comparison of change from baseline of conspicuous depth of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.348Wilcoxon (Mann-Whitney)
Comparison: Comparison of change from baseline of conspicuous depth of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.19Wilcoxon (Mann-Whitney)
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).
Time frame: 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).
Population: Intent-to-treat (ITT) population: any subject included in the study with at least a post-basal value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystal Peel | 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. | Conspicuous depth of line marks at Day 0 | 7.57 arbitrary unit | Standard Deviation 0.87 |
| Crystal Peel | 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. | Conspicuous depth of line marks at Day 15 | 7.21 arbitrary unit | Standard Deviation 0.75 |
| Crystal Peel | 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. | Conspicuous depth of line marks at Day 36 | 7.26 arbitrary unit | Standard Deviation 0.86 |
| Crystal Peel | 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. | Conspicuous depth of line marks at Day 57 | 7.19 arbitrary unit | Standard Deviation 0.78 |
| Crystal Peel | 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. | Conspicuous depth of line marks at Day 78 | 7.57 arbitrary unit | Standard Deviation 0.91 |
Comparison: Comparison of change from baseline of conspicuous depth of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.p-value: 0.005t-test, 2 sided
Comparison: 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.p-value: 0.035t-test, 2 sided
Comparison: 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.p-value: 0.036t-test, 2 sided
Comparison: 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.p-value: 0.784t-test, 2 sided
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).
Time frame: 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).
Population: Intent-to-treat (ITT) population: any subject included in the study with at least a post-basal value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystal Peel | 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. | Conspicuous length of line marks at Day 0 | 14139.88 number of pixels | Standard Deviation 10628.03 |
| Crystal Peel | 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. | Conspicuous length of line marks at Day 15 | 11890.16 number of pixels | Standard Deviation 8944.85 |
| Crystal Peel | 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. | Conspicuous length of line marks at Day 36 | 11824.88 number of pixels | Standard Deviation 7823.46 |
| Crystal Peel | 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. | Conspicuous length of line marks at Day 57 | 10849.32 number of pixels | Standard Deviation 6827.8 |
| Crystal Peel | 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. | Conspicuous length of line marks at Day 78 | 13980.52 number of pixels | Standard Deviation 10631.19 |
Comparison: 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.p-value: 0.007Wilcoxon (Mann-Whitney)
Comparison: Comparison of change from baseline of conspicuous length of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.p-value: 0.011Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.074Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.779Wilcoxon (Mann-Whitney)
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.
Time frame: 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).
Population: Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Number of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Conspicuous number of detected pores at Day 0 | 355.03 number of detected pores | Standard Deviation 133.03 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Number of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Conspicuous number of detected pores at Day 15 | 307.79 number of detected pores | Standard Deviation 133.99 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Number of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Conspicuous number of detected pores at Day 36 | 324.18 number of detected pores | Standard Deviation 133.92 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Number of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Conspicuous number of detected pores at Day 57 | 309.34 number of detected pores | Standard Deviation 110.8 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Number of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Conspicuous number of detected pores at Day 78 | 321.91 number of detected pores | Standard Deviation 123.81 |
Comparison: Comparison of change from baseline of conspicuous number of detected pores at day 15 to evaluate the improvement of pores assessed by Colorface device.p-value: <0.0001t-test, 2 sided
Comparison: Comparison of change from baseline of conspicuous number of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.01t-test, 2 sided
Comparison: Comparison of change from baseline of conspicuous number of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.p-value: <0.004t-test, 2 sided
Comparison: Comparison of change from baseline of conspicuous number of detected pores at day 78 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.013t-test, 2 sided
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.
Time frame: 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).
Population: Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystal Peel | 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. | Conspicuous relative area (density) of detected pores at Day 0 | 7.88 percentage | Standard Deviation 3.23 |
| Crystal Peel | 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. | Conspicuous relative area (density) of detected pores at Day 15 | 6.69 percentage | Standard Deviation 3.32 |
| Crystal Peel | 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. | Conspicuous relative area (density) of detected pores at Day 36 | 7.21 percentage | Standard Deviation 3.4 |
| Crystal Peel | 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. | Conspicuous relative area (density) of detected pores at Day 57 | 6.82 percentage | Standard Deviation 3.01 |
| Crystal Peel | 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. | Conspicuous relative area (density) of detected pores at Day 78 | 7.23 percentage | Standard Deviation 3.37 |
Comparison: 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.p-value: 0.006t-test, 2 sided
Comparison: Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.p-value: <0.0001t-test, 2 sided
Comparison: 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.p-value: 0.029t-test, 2 sided
Comparison: 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.p-value: 0.037t-test, 2 sided
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.
Time frame: 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).
Population: Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Volume of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Conspicuous volume of detected pores at Day 0 | 143085.53 arbitrary unit | Standard Deviation 83078.48 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Volume of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Conspicuous volume of detected pores at Day 15 | 116589.71 arbitrary unit | Standard Deviation 78431.52 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Volume of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Conspicuous volume of detected pores at Day 36 | 128638.51 arbitrary unit | Standard Deviation 83941.1 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Volume of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Conspicuous volume of detected pores at Day 57 | 116400.38 arbitrary unit | Standard Deviation 69989.53 |
| Crystal Peel | Comparison of Change From Baseline of Conspicuous Volume of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device. | Conspicuous volume of detected pores at Day 78 | 128428.39 arbitrary unit | Standard Deviation 84587.06 |
Comparison: Comparison of change from baseline of conspicuous volume of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.p-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: Comparison of change from baseline of conspicuous volume of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.073t-test, 2 sided
Comparison: Comparison of change from baseline of conspicuous volume of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.008t-test, 2 sided
Comparison: Comparison of change from baseline of conspicuous volume of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.p-value: 0.071t-test, 2 sided
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).
Time frame: 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).
Population: Intent-to-treat (ITT) population: any subject included in the study with at least a post-basal value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crystal Peel | 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. | Conspicuous volume of line marks at Day 0 | 359983.52 arbitrary unit | Standard Deviation 301542.58 |
| Crystal Peel | 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. | Conspicuous volume of line marks at Day 15 | 284182.77 arbitrary unit | Standard Deviation 237265.18 |
| Crystal Peel | 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. | Conspicuous volume of line marks at Day 36 | 286465.65 arbitrary unit | Standard Deviation 206832.97 |
| Crystal Peel | 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. | Conspicuous volume of line marks at Day 57 | 254170.91 arbitrary unit | Standard Deviation 169281.12 |
| Crystal Peel | 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. | Conspicuous volume of line marks at Day 78 | 345909.82 arbitrary unit | Standard Deviation 284856.86 |
Comparison: Comparison of change from baseline of conspicuous volume of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.p-value: 0.003Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.054Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.008Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.779t-test, 2 sided
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.
Time frame: At Visit 5/Day 78).
Population: Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigational plan).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crystal Peel | Local and Overall Tolerance of the Crystal Peel. | Very good tolerance | 10 Participants |
| Crystal Peel | Local and Overall Tolerance of the Crystal Peel. | Good tolerance | 21 Participants |
| Crystal Peel | Local and Overall Tolerance of the Crystal Peel. | Moderate tolerance | 1 Participants |
| Crystal Peel | Local and Overall Tolerance of the Crystal Peel. | Bad tolerance | 1 Participants |
95% CI: [1.98, 2.44]
Secondary
Number of Adverse Events
Collection of adverse events by the investigator. Please refer to Adverse Events tables for more details.
Time frame: 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).
Population: Safety population: any subject having used the investigational device. 33 patients have been analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Crystal Peel | Number of Adverse Events | Adverse events related to studied product : moderate | 0 adverse events |
| Crystal Peel | Number of Adverse Events | Adverse events not related to studied product : mild | 92 adverse events |
| Crystal Peel | Number of Adverse Events | Adverse events not related to studied product : moderate | 22 adverse events |
| Crystal Peel | Number of Adverse Events | Adverse events not related to studied product : severe | 0 adverse events |
| Crystal Peel | Number of Adverse Events | Adverse events related to studied product : mild | 103 adverse events |
| Crystal Peel | Number of Adverse Events | Adverse events related to studied product : severe | 0 adverse events |
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).
Time frame: At Visit 5/Day 78.
Population: Per protocol (PP) population (any patient having used at least once the investigational device and without any major deviation to the clinical investigation plan.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crystal Peel | Subject's Satisfaction Questionnaire | The treatment you tried prevented your acne from getting worse | 26 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | The treatment you have experienced has reduced the surface area of your acne | 31 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | Blemishes are visibly reduced | 29 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | Pores are tightened and less visible | 31 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | Skin texture is improved | 28 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | The skin is matified | 30 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | The skin is clearer | 30 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | Satisfactory effectiveness of this treatment | 28 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | This treatment is of high performance | 26 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | I am delighted with the results obtained to date | 26 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | The treatment met my needs | 29 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | The treatment is not restrictive | 28 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | Compared to other treatments, this one is more effective | 25 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | Thanks to this treatment, I feel better in my skin | 28 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | I would like to continue this treatment | 33 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | I will be interested in renewing this treatment with a practitioner | 33 Participants |
| Crystal Peel | Subject's Satisfaction Questionnaire | I will advise someone else to use this treatment | 33 Participants |
95% CI: [61, 89]
Comparison: Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.95% CI: [80, 98]
Comparison: Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.95% CI: [73, 95]
Comparison: Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.95% CI: [68, 93]
Comparison: Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.95% CI: [77, 97]
Comparison: Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.95% CI: [69, 93]
Comparison: Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.95% CI: [61, 89]
Comparison: Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.95% CI: [62, 89]
Comparison: Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.95% CI: [59, 87]