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| Name | Class |
|---|---|
| Lumenis Be Ltd. | INDUSTRY |
| Taipei Medical University Shuang Ho Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High energy | Other | 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 |
|
| Low energy | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High energy (UltraPulse) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Topographic 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 | 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 | three month after the 2nd treatment session from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuo-Liang Cheng, MD | Contact | +886-28787-2112 | dermacarl@hotmail.com | |
| Donald Liu, MBChB, PhD | Contact | +886-22249-0088 | 2387 | 16308@s.tmu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Kuo-Liang Cheng, MD | Haute Beauté Skin & Vein Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HAUTE BEAUTÉ Skin & Vein Clinic | Recruiting | Taipei | 110 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25296739 | Background | Dreno B, Thiboutot D, Layton AM, Berson D, Perez M, Kang S; Global Alliance to Improve Outcomes in Acne. Large-scale international study enhances understanding of an emerging acne population: adult females. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1096-106. doi: 10.1111/jdv.12757. Epub 2014 Oct 8. | |
| 31531167 | Background |
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Low energy:
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
High energy:
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
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| Low energy (UltraPulse) | Device | 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 |
|
| 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. | 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 | Compare the difference of newly synthesis collagen and elastic fiber through staining in the low versus high energy treated arm | 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 | 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 | after the 2nd treatment session、one month and three month after the 2nd treatment session |
| Bhargava S, Kumar U, Varma K. Subcision and Microneedling as an Inexpensive and Safe Combination to Treat Atrophic Acne Scars in Dark Skin: A Prospective Study of 45 Patients at a Tertiary Care Center. J Clin Aesthet Dermatol. 2019 Aug;12(8):18-22. Epub 2019 Aug 1. |
| 11423843 | Background | Jacob CI, Dover JS, Kaminer MS. Acne scarring: a classification system and review of treatment options. J Am Acad Dermatol. 2001 Jul;45(1):109-17. doi: 10.1067/mjd.2001.113451. |
| 31985622 | Background | Alster TS, Li MKY. Microneedling of Scars: A Large Prospective Study with Long-Term Follow-Up. Plast Reconstr Surg. 2020 Feb;145(2):358-364. doi: 10.1097/PRS.0000000000006462. |
| 31413476 | Background | Arsiwala SZ, Desai SR. Fractional Carbon Dioxide Laser: Optimizing Treatment Outcomes for Pigmented Atrophic Acne Scars in Skin of Color. J Cutan Aesthet Surg. 2019 Apr-Jun;12(2):85-94. doi: 10.4103/JCAS.JCAS_171_18. |
| 31584784 | Background | Emer J. Platelet-Rich Plasma (PRP): Current Applications in Dermatology. Skin Therapy Lett. 2019 Sep;24(5):1-6. |
| 31496020 | Background | Mu YZ, Jiang L, Yang H. The efficacy of fractional ablative carbon dioxide laser combined with other therapies in acne scars. Dermatol Ther. 2019 Nov;32(6):e13084. doi: 10.1111/dth.13084. Epub 2019 Oct 7. |
| 31478266 | Background | Tanizaki H, Tanioka M, Yamashita Y, Hayashi N. Quantitative evaluation of atrophic acne scars using 3D image analysis with reflected LED light. Skin Res Technol. 2020 Jan;26(1):20-24. doi: 10.1111/srt.12756. Epub 2019 Sep 2. |
| 29512189 | Background | Petit L, Zugaj D, Bettoli V, Dreno B, Kang S, Tan J, Torres V, Layton AM, Martel P. Validation of 3D skin imaging for objective repeatable quantification of severity of atrophic acne scarring. Skin Res Technol. 2018 Nov;24(4):542-550. doi: 10.1111/srt.12464. Epub 2018 Mar 6. |