Trial Outcomes & Findings for Evaluation of Efficacy and Tolerance of Crystal Peel in the Treatment of Adults Presenting Facial Mild Acne (NCT NCT05821296)
NCT ID: NCT05821296
Last Updated: 2024-10-15
Results Overview
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).
COMPLETED
NA
42 participants
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).
2024-10-15
Participant Flow
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.
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).
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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33
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Overall Study
COMPLETED
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33
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Crystal Peel
n=33 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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|---|---|
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Age, Continuous
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24 years
STANDARD_DEVIATION 5 • n=33 Participants
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Sex: Female, Male
Female
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27 Participants
n=33 Participants
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Sex: Female, Male
Male
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6 Participants
n=33 Participants
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Region of Enrollment
Poland
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33 participants
n=33 Participants
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Fitzpatrick skin phototype
Skin phototype I
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0 participants
n=33 Participants
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Fitzpatrick skin phototype
Skin phototype II
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26 participants
n=33 Participants
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Fitzpatrick skin phototype
Skin phototype III
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7 participants
n=33 Participants
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Fitzpatrick skin phototype
Skin phototype IV
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0 participants
n=33 Participants
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PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Crystal Peel
n=943 Lesions count at each protocol visit
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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|---|---|
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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
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943 Lesions count at each protocol visit
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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
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647 Lesions count at each protocol visit
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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
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457 Lesions count at each protocol visit
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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
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407 Lesions count at each protocol visit
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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
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463 Lesions count at each protocol visit
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SECONDARY outcome
Timeframe: 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).
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).
Outcome measures
| Measure |
Crystal Peel
n=33 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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|---|---|
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Acne Investigator Global Assessment (IGA) Score
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1.85 score on a scale
Standard Deviation 0.87
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SECONDARY outcome
Timeframe: 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).
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).
Outcome measures
| Measure |
Crystal Peel
n=33 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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|---|---|
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Acne Patient Global Assessment (PGA) Scale
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1.82 score on a scale
Standard Deviation 1.07
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SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Crystal Peel
n=33 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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Local and Overall Tolerance of the Crystal Peel.
Very good tolerance
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10 Participants
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Local and Overall Tolerance of the Crystal Peel.
Good tolerance
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21 Participants
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Local and Overall Tolerance of the Crystal Peel.
Moderate tolerance
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1 Participants
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Local and Overall Tolerance of the Crystal Peel.
Bad tolerance
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1 Participants
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SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Crystal Peel
n=33 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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|---|---|
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Subject's Satisfaction Questionnaire
The treatment you tried prevented your acne from getting worse
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26 Participants
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Subject's Satisfaction Questionnaire
The treatment you have experienced has reduced the surface area of your acne
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31 Participants
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Subject's Satisfaction Questionnaire
Blemishes are visibly reduced
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29 Participants
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Subject's Satisfaction Questionnaire
Pores are tightened and less visible
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31 Participants
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Subject's Satisfaction Questionnaire
Skin texture is improved
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28 Participants
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Subject's Satisfaction Questionnaire
The skin is matified
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30 Participants
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Subject's Satisfaction Questionnaire
The skin is clearer
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30 Participants
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Subject's Satisfaction Questionnaire
Satisfactory effectiveness of this treatment
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28 Participants
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Subject's Satisfaction Questionnaire
This treatment is of high performance
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26 Participants
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Subject's Satisfaction Questionnaire
I am delighted with the results obtained to date
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26 Participants
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Subject's Satisfaction Questionnaire
The treatment met my needs
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29 Participants
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Subject's Satisfaction Questionnaire
The treatment is not restrictive
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28 Participants
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Subject's Satisfaction Questionnaire
Compared to other treatments, this one is more effective
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25 Participants
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Subject's Satisfaction Questionnaire
Thanks to this treatment, I feel better in my skin
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28 Participants
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Subject's Satisfaction Questionnaire
I would like to continue this treatment
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33 Participants
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Subject's Satisfaction Questionnaire
I will be interested in renewing this treatment with a practitioner
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33 Participants
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Subject's Satisfaction Questionnaire
I will advise someone else to use this treatment
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33 Participants
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SECONDARY outcome
Timeframe: 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.
Collection of adverse events by the investigator. Please refer to Adverse Events tables for more details.
Outcome measures
| Measure |
Crystal Peel
n=217 adverse events
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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Number of Adverse Events
Adverse events not related to studied product : mild
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92 adverse events
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Number of Adverse Events
Adverse events not related to studied product : moderate
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22 adverse events
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Number of Adverse Events
Adverse events not related to studied product : severe
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0 adverse events
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Number of Adverse Events
Adverse events related to studied product : mild
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103 adverse events
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Number of Adverse Events
Adverse events related to studied product : moderate
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0 adverse events
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Number of Adverse Events
Adverse events related to studied product : severe
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0 adverse events
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SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Crystal Peel
n=33 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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|---|---|
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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
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355.03 number of detected pores
Standard Deviation 133.03
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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
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307.79 number of detected pores
Standard Deviation 133.99
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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
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324.18 number of detected pores
Standard Deviation 133.92
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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
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309.34 number of detected pores
Standard Deviation 110.80
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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
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321.91 number of detected pores
Standard Deviation 123.81
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SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Crystal Peel
n=33 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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|---|---|
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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
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19088.48 total number of pixels
Standard Deviation 9179.66
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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
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16256.09 total number of pixels
Standard Deviation 9179.12
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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
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17333.61 total number of pixels
Standard Deviation 8895.27
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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
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16109.97 total number of pixels
Standard Deviation 7666.83
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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
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17130.97 total number of pixels
Standard Deviation 8546.22
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SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Crystal Peel
n=33 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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|---|---|
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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
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7.88 percentage
Standard Deviation 3.23
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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
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6.69 percentage
Standard Deviation 3.32
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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
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7.21 percentage
Standard Deviation 3.40
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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
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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
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SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Crystal Peel
n=33 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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|---|---|
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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
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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
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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 1.10
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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
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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
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SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Crystal Peel
n=33 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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|---|---|
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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
|
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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
|
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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
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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
|
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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
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Crystal Peel
n=33 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.
|
|---|---|
|
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
|
|
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
|
|
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 83941.10
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Crystal Peel
n=32 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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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
|
|
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
|
|
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
|
|
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
|
|
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 31379.00
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Crystal Peel
n=32 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Crystal Peel
n=32 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 6827.80
|
|
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
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Crystal Peel
n=32 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
Crystal Peel
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Crystal Peel
n=33 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Burning sensation
|
97.0%
32/33 • Number of events 51 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Desquamation
|
51.5%
17/33 • Number of events 17 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Dryness
|
39.4%
13/33 • Number of events 18 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
100.0%
33/33 • Number of events 52 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Itching
|
15.2%
5/33 • Number of events 6 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Sensation of coolness after peel application
|
3.0%
1/33 • Number of events 1 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
36.4%
12/33 • Number of events 20 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Stinging
|
9.1%
3/33 • Number of events 3 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Superficial skin whitening after peel application
|
18.2%
6/33 • Number of events 6 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Tingling
|
18.2%
6/33 • Number of events 11 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Warm sensation
|
12.1%
4/33 • Number of events 4 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
9.1%
3/33 • Number of events 3 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
1/33 • Number of events 1 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Ear and labyrinth disorders
Earache
|
3.0%
1/33 • Number of events 1 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Infections and infestations
Flu
|
3.0%
1/33 • Number of events 1 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
General disorders
Headache
|
24.2%
8/33 • Number of events 8 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
3.0%
1/33 • Number of events 1 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Endocrine disorders
Menstrual pain
|
12.1%
4/33 • Number of events 4 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Oedema
|
3.0%
1/33 • Number of events 1 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
3.0%
1/33 • Number of events 1 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore thorat
|
6.1%
2/33 • Number of events 2 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Gastrointestinal disorders
Stomachache
|
3.0%
1/33 • Number of events 1 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Musculoskeletal and connective tissue disorders
Toothache
|
3.0%
1/33 • Number of events 1 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
1/33 • Number of events 1 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Increase in acne lesions
|
3.0%
1/33 • Number of events 1 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Inflammatory lump on right cheek after insect bite
|
3.0%
1/33 • Number of events 1 • 78 days.
Adverse events collection came from patient's diary and regular investigator assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER