Purpose of the study is to assess the effect and evaluate topographic volume changes of UltraPulse at treating boxcar scars with different energy and the effect of UltraPulse at treating icepick scars.
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 24 hour screening period to determine eligibility for study entry. Upon enrollment, patient who fulfill all the inclusion criteria and does not fulfill any exclusion criteria will be scheduled for their visits. All subjects will be receiving two sessions of treatment, with the two sessions 8-12 weeks apart. Subjects' face will be divided to left and right, with each side randomized to receive a low versus high energy setting. In the low energy setting side of the face, central base of boxcar scar will be treated with 20mJ, while shoulder of scar will be treated with 50 mJ. In the high energy setting side of the face, central base of boxcar scar will be treated with 30mJ, while shoulder of scar will be treated with 60 mJ. Subject will be blinded regarding which side of the face received low versus high energy setting. Ultrasound will be used to assess epidermal and dermal thickness change at the treated area. This will be performed before the 1st and 2nd treatment session as well as one month and three month after the 2nd treatment session. Antera Quantitative 3D Image Analysis will be performed before and after the 1st and 2nd treatment session as well as one month and three month after the 2nd treatment session. 3mm punch biopsy will be taken from 10 volunteers over bilateral face before the 1st treatment session and 3 month after the 2nd treatment session (total of 4 sample will be obtained in each volunteer). Skin specimen will be stained with hematoxylin and eosin as well as relevant stain for collagen and elastic fiber. Clinical photograph will be taken before and after the 1st and 2nd treatment session as well as one month and three month after the 2nd treatment session. Two blinded board certified dermatologist will be asked to rate the improvement of acne scar by GSAAS according to the clinical photograph taken. All subjects will be asked to rate their satisfaction regarding treatment response over each side of the face using a 0 to 10 point scale chart.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Half of the face that receives low energy, their central base of boxcar scar will be treated with 30mJ, while shoulder of scar will be treated with 60 mJ
Half of the face that receives low energy, their central base of boxcar scar will be treated with 20mJ, while shoulder of scar will be treated with 50 mJ
HAUTE BEAUTÉ Skin & Vein Clinic
Taipei, Taiwan
RECRUITINGTopographic volume changes of acne scars from baseline one month and three month after the 2nd treatment session
Topographic volume changes of acne scars from baseline one month and three month after the 2nd treatment session
Time frame: from baseline one month and three month after the 2nd treatment session
Histological change in epidermal/dermal component including elastic fiber and collagen synthesis three month after the 2nd treatment session from baseline
Histological change in epidermal/dermal component including elastic fiber and collagen synthesis three month after the 2nd treatment session from baseline
Time frame: three month after the 2nd treatment session from baseline
Access improvement of acne scar by Scale for global severity of facial acne scar from baseline one month and three month after the 2nd treatment session in both the low and high energy treated arm
Access improvement of acne scar by Scale for global severity of facial acne scar from baseline one month and three month after the 2nd treatment session in both the low and high energy treated arm. The minimum and maximum values of Scale for global severity of facial acne scar are 0 and 5, and higher scores mean a worse outcome.
Time frame: from baseline one month and three month after the 2nd treatment session
Compare the difference of improvement of acne scar by Scale for global severity of facial acne scar in the low versus high energy treated arm
Compare the difference of improvement of acne scar by Scale for global severity of facial acne scar in the low versus high energy treated arm. The minimum and maximum values of Scale for global severity of facial acne scar are 0 and 5, and higher scores mean a worse outcome.
Time frame: from baseline and three month after the 2nd treatment session
Compare the difference of newly synthesis collagen and elastic fiber through staining in the low versus high energy treated arm
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Compare the difference of newly synthesis collagen and elastic fiber through staining in the low versus high energy treated arm
Time frame: from baseline and three month after the 2nd treatment session
Assess the frequency and severity of encountered side effects in the low versus high energy treated arm
Assess the frequency and severity of encountered side effects in the low versus high energy treated arm
Time frame: from baseline and three month after the 2nd treatment session
Subjects' satisfaction score rated in a 0 to 10 point scale
Subjects' satisfaction score rated in a 0 to 10 point scale
Time frame: after the 2nd treatment session、one month and three month after the 2nd treatment session