Evaluation of Efficacy and Tolerance of Crystal Peel in the Treatment of Adults Presenting Facial Mild Acne

Study Overview
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Brief Summary
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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: 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
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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).

Official Title
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Evaluation of the Efficacy and Tolerance of Crystal Peel (a Salicylic Acid Based Peel) in the Treatment of Acne

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Device: Crystal Peel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects Gender: female and/or male. Age: 18 - 45 Phototype I to IV according Fitzpatrick scale. Healthy subject with normal physical examination results and a medical history compatible with the requirements of the study. 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). 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. Subject agrees not to apply any cosmetic, medical or aesthetic treatments outside the study protocol on the face for the duration of the study. 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: Pregnant or nursing woman or planning a pregnancy during the study. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship. Subject in a social or sanitary establishment. Subject participating to another clinical research or being in an exclusion period for a previous study. Intensive exposure to sunlight or UV-rays within the previous 3 months and foreseen during the study. 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. Subject having history of allergy or hypersensitivity to one of the components of the tested device. Subject receiving any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject to undue risk. 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). Subjects with known salicylism or related medical indications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Crystal Peel<br>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. | Device: Crystal Peel<br>* 3 applications performed by a dermatologist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the change from baseline of total sum of 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). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment score. | The investigator (the second evaluator not performing the peeling act) will evaluate the global effect of the medical device using the following scale: Worse (-1); No improvement (0); Slight improvement (1); Good improvement (2); Very good improvement (3) | At Visit 5/Day 78. | 
| Patient Global Assessment score. | The subject will evaluate the global effect of the medical device using the following scale: Worse (-1); No improvement (0); Slight improvement (1); Good improvement (2); Very good improvement (3) | 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 will be assessed during the clinical examination. Abnormal clinical signs and subjective signs reported by the subjects will be reported in the CRF. According to these signs, the local tolerance of the product will be defined on the following scale: 0= Bad tolerance Moderate tolerance Good tolerance Very good tolerance. | At Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78). | 
| Subject's self-evaluation. | Subjects will be asked to complete the satisfaction questionnaire. First question related to the global appreciation of Crystal Peel. Possible answers: very pleasant, pleasant, neither pleasant nor unpleasant, unpleasant or very unpleasant. Other 14 questions related to efficiency of Crystal Peel. Possible answers: totally agree, agree, no agreement or not at all in agreement. And 3 last questions related the future use of Crystal Peel. Possible answers: Yes or No. | At Visit 5/Day 78. | 
| Adverse events number. | Collection of adverse events by the investigator. | 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 and 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 replaced at other timepoints 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 at least one of the following parameters is statistically decreasing and the other ones remain stable and/or not statistically increasing: 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 and 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 replaced at other timepoints 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 at least one of the following parameters is statistically decreasing and the other ones remain stable and/or not statistically increasing: 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 and 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 replaced at other timepoints 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 at least one of the following parameters is statistically decreasing and the other ones remain stable and/or not statistically increasing: 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 and 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 replaced at other timepoints 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 at least one of the following parameters is statistically decreasing and the other ones remain stable and/or not statistically increasing: 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 and 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 replaced at other timepoints 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 at least one of the following parameters is statistically decreasing and the other ones remain stable and/or not statistically increasing: 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 and 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 replaced at other timepoints 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 at least one of the following parameters is statistically decreasing and the other ones remain stable and/or not statistically increasing: 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 in standard 60 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 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 at least one of the following parameters is statistically decreasing and the other ones remain stable and/or not statistically increasing: 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 in standard 60 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 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 at least one of the following parameters is statistically decreasing and the other ones remain stable and/or not statistically increasing: 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 in standard 60 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 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 at least one of the following parameters is statistically decreasing and the other ones remain stable and/or not statistically increasing: 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 in standard 60 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 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 at least one of the following parameters is statistically decreasing and the other ones remain stable and/or not statistically increasing: 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). | 
| Comparision of the change from baseline of the contrast on each visit to evaluate the improvement of the smoothness of skin. | Profiles images in cross 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 thanks to a spatial registration algorithm. The contrast is a measurement of local variations. It is computed from the co-occurrence matrix. This matrix contains parameters called Haralick indicators. There is an improvement of the smoothness of skin if at least one of the following parameters is statistically decreasing and the other ones remain stable (no statistically significance) and/or not statistically increasing: contrast (unit=arbitrary unit) and entropy of skin color texture (unit=arbitrary unit). Each one defined by a particular | 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 the change from baseline of the entropy on each visit to evaluate the improvement of skin roughness. | Profiles images in cross 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 thanks to a spatial registration algorithm. The entropy is a measurement of randomness of the distribution intensity. It is computed from the cooccurrence matrix. This matrix contains parameters called Haralick indicators. There is an improvement of skin roughness if at least one of the following parameters is statistically decreasing and the other ones remain stable (no statistically significance) and/or not statistically increasing: contrast (unit=arbitrary unit) and entropy of skin color texture (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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne, facial, crystal peel, salicylic acid