Change from baseline skin thickness at 3 months after the last treatment session.
Before the treatment and three months after the final session, a high-frequency ultrasound system (Supersonic Mach 30, Hologic, SuperSonic Imagine, Aix-en-Provence, France), which uses a 20 MHz linear probe with 8mm penetration, 30x12m um resolution, provides a quantitative assessment and measurements in mm. Acquired HFUS images are imported into MATLAB's image segmenter to segment and delineate skin layers. A MATLAB code is applied to assess skin thickness from segmented images. The skin's overall thickness, epidermis, and dermis at the treatment sites are also measured (unit: mm).
Change from baseline skin thickness at 6 months after the last treatment session.
Before the treatment and six months after the final session, a high-frequency ultrasound system (Supersonic Mach 30, Hologic, SuperSonic Imagine, Aix-en-Provence, France), which uses a 20 MHz linear probe with 8mm penetration, 30x12m um resolution, provides a quantitative assessment and measurements in mm. Acquired HFUS images are imported into MATLAB's image segmenter to segment and delineate skin layers. A MATLAB code is applied to assess skin thickness from segmented images. The skin's overall thickness, epidermis, and dermis at the treatment sites are also measured (unit: mm).
ECCA score at baseline
The ECCA score (echelle d'evaluation clinique des cicatrices d'acne) provides a quantitative grading score for evaluating scars' severity and clinical improvement, with a minimum - maximum value is 0 - 540. A higher score means higher severity of acne scars condition.
ECCA score at week 4
The ECCA score (echelle d'evaluation clinique des cicatrices d'acne) provides a quantitative grading score for evaluating scars' severity and clinical improvement, with a minimum - maximum value is 0 - 540. A higher score means higher severity of acne scars condition.
ECCA score at week 8
The ECCA score (echelle d'evaluation clinique des cicatrices d'acne) provides a quantitative grading score for evaluating scars' severity and clinical improvement, with a minimum - maximum value is 0 - 540. A higher score means higher severity of acne scars condition.
ECCA score at Week 12
The ECCA score (echelle d'evaluation clinique des cicatrices d'acne) provides a quantitative grading score for evaluating scars' severity and clinical improvement, with a minimum - maximum value is 0 - 540. A higher score means higher severity of acne scars condition.
ECCA score at 3 months after the last treatment session.
The ECCA score (echelle d'evaluation clinique des cicatrices d'acne) provides a quantitative grading score for evaluating scars' severity and clinical improvement, with a minimum - maximum value is 0 - 540. A higher score means higher severity of acne scars condition.
ECCA score at 6 months after the last treatment session.
The ECCA score (echelle d'evaluation clinique des cicatrices d'acne) provides a quantitative grading score for evaluating scars' severity and clinical improvement, with a minimum - maximum value is 0 - 540. A higher score means higher severity of acne scars condition.
Investigator's Global Assessment at Week 4
Photographs (five photos taken at 0,45 and 90 degrees of each half face, and multiple close-ups at the scar sites) are taken at baseline, before each treatment session, and three months after the last session. When comparing images taken prior to and after therapy, the head's position, distance from the camera, and illumination remain constant. Evaluation of global assessment to treatment by a blinded investigator is done using patient photographs of before and after treatment. Rating the Investigator's Global Response to treatment is done using a quartile grading scale (0 = no improvement 0%; 1 = mild improvement 1% - 25%;2 = moderate improvement 25%-49%; 3 = significant improvement 50%-74%; 4= marked improvement ≥ 75%).
Investigator's Global Assessment at Week 8
Photographs (five photos taken at 0,45 and 90 degrees of each half face, and multiple close-ups at the scar sites) are taken at baseline, before each treatment session, and three months after the last session. When comparing images taken prior to and after therapy, the head's position, distance from the camera, and illumination remain constant. Evaluation of global assessment to treatment by a blinded investigator is done using patient photographs of before and after treatment. Rating the Investigator's Global Response to treatment is done using a quartile grading scale (0 = no improvement 0%; 1 = mild improvement 1% - 25%;2 = moderate improvement 25%-49%; 3 = significant improvement 50%-74%; 4= marked improvement ≥ 75%).
Investigator's Global Assessment at Week 12
Photographs (five photos taken at 0,45 and 90 degrees of each half face, and multiple close-ups at the scar sites) are taken at baseline, before each treatment session, and three months after the last session. When comparing images taken prior to and after therapy, the head's position, distance from the camera, and illumination remain constant. Evaluation of global assessment to treatment by a blinded investigator is done using patient photographs of before and after treatment. Rating the Investigator's Global Response to treatment is done using a quartile grading scale (0 = no improvement 0%; 1 = mild improvement 1% - 25%;2 = moderate improvement 25%-49%; 3 = significant improvement 50%-74%; 4= marked improvement ≥ 75%).
Investigator's Global Assessment at 3 months
Photographs (five photos taken at 0,45 and 90 degrees of each half face, and multiple close-ups at the scar sites) are taken at baseline, before each treatment session, and three months after the last session. When comparing images taken prior to and after therapy, the head's position, distance from the camera, and illumination remain constant. Evaluation of global assessment to treatment by a blinded investigator is done using patient photographs of before and after treatment. Rating the Investigator's Global Response to treatment is done using a quartile grading scale (0 = no improvement 0%; 1 = mild improvement 1% - 25%;2 = moderate improvement 25%-49%; 3 = significant improvement 50%-74%; 4= marked improvement ≥ 75%).
Investigator's Global Assessment at 6 months
Photographs (five photos taken at 0,45 and 90 degrees of each half face, and multiple close-ups at the scar sites) are taken at baseline, before each treatment session, and three months after the last session. When comparing images taken prior to and after therapy, the head's position, distance from the camera, and illumination remain constant. Evaluation of global assessment to treatment by a blinded investigator is done using patient photographs of before and after treatment. Rating the Investigator's Global Response to treatment is done using a quartile grading scale (0 = no improvement 0%; 1 = mild improvement 1% - 25%;2 = moderate improvement 25%-49%; 3 = significant improvement 50%-74%; 4= marked improvement ≥ 75%).
Patient's Global Assessment at Week 4
Photographs (five photos taken at 0,45 and 90 degrees of each half face, and multiple close-ups at the scar sites) are taken at baseline, before each treatment session, and three months after the last session. When comparing images taken prior to and after therapy, the head's position, distance from the camera, and illumination remain constant. Evaluation of global assessment to treatment by patients is done using patient photographs of before and after treatment. Rating the Investigator's Global Response to treatment is done using a quartile grading scale (0 = no improvement 0%; 1 = mild improvement 1% - 25%;2 = moderate improvement 25%-49%; 3 = significant improvement 50%-74%; 4= marked improvement ≥ 75%).
Patient's Global Assessment at Week 8
Photographs (five photos taken at 0,45 and 90 degrees of each half face, and multiple close-ups at the scar sites) are taken at baseline, before each treatment session, and three months after the last session. When comparing images taken prior to and after therapy, the head's position, distance from the camera, and illumination remain constant. Evaluation of global assessment to treatment by patients is done using patient photographs of before and after treatment. Rating the Investigator's Global Response to treatment is done using a quartile grading scale (0 = no improvement 0%; 1 = mild improvement 1% - 25%;2 = moderate improvement 25%-49%; 3 = significant improvement 50%-74%; 4= marked improvement ≥ 75%).
Patient's Global Assessment at Week 12
Photographs (five photos taken at 0,45 and 90 degrees of each half face, and multiple close-ups at the scar sites) are taken at baseline, before each treatment session, and three months after the last session. When comparing images taken prior to and after therapy, the head's position, distance from the camera, and illumination remain constant. Evaluation of global assessment to treatment by patients is done using patient photographs of before and after treatment. Rating the Investigator's Global Response to treatment is done using a quartile grading scale (0 = no improvement 0%; 1 = mild improvement 1% - 25%;2 = moderate improvement 25%-49%; 3 = significant improvement 50%-74%; 4= marked improvement ≥ 75%).
Patient's Global Assessment at 3 months
Photographs (five photos taken at 0,45 and 90 degrees of each half face, and multiple close-ups at the scar sites) are taken at baseline, before each treatment session, and three months after the last session. When comparing images taken prior to and after therapy, the head's position, distance from the camera, and illumination remain constant. Evaluation of global assessment to treatment by patients is done using patient photographs of before and after treatment. Rating the Investigator's Global Response to treatment is done using a quartile grading scale (0 = no improvement 0%; 1 = mild improvement 1% - 25%;2 = moderate improvement 25%-49%; 3 = significant improvement 50%-74%; 4= marked improvement ≥ 75%).
Patient's Global Assessment at 6 months
Photographs (five photos taken at 0,45 and 90 degrees of each half face, and multiple close-ups at the scar sites) are taken at baseline, before each treatment session, and three months after the last session. When comparing images taken prior to and after therapy, the head's position, distance from the camera, and illumination remain constant. Evaluation of global assessment to treatment by patients is done using patient photographs of before and after treatment. Rating the Investigator's Global Response to treatment is done using a quartile grading scale (0 = no improvement 0%; 1 = mild improvement 1% - 25%;2 = moderate improvement 25%-49%; 3 = significant improvement 50%-74%; 4= marked improvement ≥ 75%).
Patients Satisfaction
Patients are asked to rate their satisfaction with each type of combination therapy on a four-point Likert scale with the following anchors: extremely satisfied, satisfied, partially satisfied, and dissatisfied.
Pain level after laser
Pain level is documented (using a ten-point Visual Analog Scale). Patients will be asked to rate their pain level on the scale of 10 (minumum: 0, no pain; maximum: 10, extremely pain)
Pain level after laser
Pain level is documented (using a ten-point Visual Analog Scale). Patients will be asked to rate their pain level on the scale of 10 (minumum: 0, no pain; maximum: 10, extremely pain)
Pain level after laser
Pain level is documented (using a ten-point Visual Analog Scale). Patients will be asked to rate their pain level on the scale of 10 (minumum: 0, no pain; maximum: 10, extremely pain)
Pain level after subcision
Pain level is documented (using a ten-point Visual Analog Scale). Patients will be asked to rate their pain level on the scale of 10 (minumum: 0, no pain; maximum: 10, extremely pain)
Pain level after subcision
Pain level is documented (using a ten-point Visual Analog Scale). Patients will be asked to rate their pain level on the scale of 10 (minumum: 0, no pain; maximum: 10, extremely pain)
Pain level after subcision
Pain level is documented (using a ten-point Visual Analog Scale). Patients will be asked to rate their pain level on the scale of 10 (minumum: 0, no pain; maximum: 10, extremely pain)
Other adverse events
Other adverse effects are also documented (Yes or No) including post-inflammatory hyperpigmentation, post-inflammatory hypopigmentation, and other side effects using a questionnaire assessing adverse events.
Other adverse events
Other adverse effects are also documented (Yes or No) including post-inflammatory hyperpigmentation, post-inflammatory hypopigmentation, and other side effects using a questionnaire assessing adverse events.
Other adverse events
Other adverse effects are also documented (Yes or No) including post-inflammatory hyperpigmentation, post-inflammatory hypopigmentation, and other side effects using a questionnaire assessing adverse events.
Erythema
The duration (unit: days) of erythema presented after a treatment session
Erythema
The duration (unit: days) of erythema presented after a treatment session
Erythema
The duration (unit: days) of erythema presented after a treatment session
Edema
The duration (unit: days) of edema presented after a treatment session
Edema
The duration (unit: days) of edema presented after a treatment session
Edema
The duration (unit: days) of edema presented after a treatment session
Crusting
The duration (unit: days) of crusting presented after a treatment session
Crusting
The duration (unit: days) of crusting presented after a treatment session
Crusting
The duration (unit: days) of crusting presented after a treatment session
Bruising
The duration (unit: days) of bruising presented after a treatment session
Bruising
The duration (unit: days) of bruising presented after a treatment session
Bruising
The duration (unit: days) of bruising presented after a treatment session
Downtime
Total downtime duration (unit: days) needed for recovery after a treatment session
Downtime
Total downtime duration (unit: days) needed for recovery after a treatment session
Downtime
Total downtime duration (unit: days) needed for recovery after a treatment session
Lump
The duration of lump presented after 3 treatment sessions (Ordinal variable with 7 values: 0 - no lump; 1 - 1 month; 2 - 2 months; 3 - 3 months; 4 - 4 months; 5 - 5 months; 6 - > 5 months)