Back to resultsTheTreatment of Acne Scar Using UltraPulse CO2 Laser
Primary Purpose
Acne Scar
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
High energy (UltraPulse)
Low energy (UltraPulse)
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scar focused on measuring UltraPulse CO2 Laser, Antera Quantitative 3D Image, Collagen, Elastic fiber, Scale for global severity of facial acne scar
Eligibility Criteria
Inclusion Criteria:
- Subjects have to be aged from 20 to 60 year-old
- Subjects currently have an area of involvement approximately 2cm × 2cm on each side of the face over the temples or cheek bone area
- Classified as mild to moderate acne scar according to global severity of facial acne scar (GSAAS) score
- After evaluation by clinician, those subjects to be treated with "Lumenis"CO2 Laser System (UltraPulse) can benefit from this laser treatment
- Subjects need to be fully functional and aware of the pros and cons of the study. Subject is capable to make self judgement and sign the inform consent under his/her own will
- Others: Have fully understand about this study and is willing to cooperate with the instruction of the study
Exclusion Criteria:
- Those who were known to have keloid formation
- Those who have porphyria or known photosensitivity
- Those who previously underwent laser therapy treatment or skin biopsy and have showed poor result or adverse effect
- Those who were classified as "severe" according to GSAAS system
- Those who have bleeding tendency
- Those who present with clinical data suggesting abnormal platelet function or coagulation disorder (such as prolonged aPTT or PT)
- Those that are currently taking anticoagulants or anti-platelet drugs
- Those who are on aspirin or other NSAIDs
- Those who have history of granulomatous or connective tissue disease
- Female subjects with a positive pregnancy test
- Women who refuse to stay on effective contraception or refuse pregnancy tests during the study
- After evaluation by the clinician, those that have been enrolled in clinical studies over the past 6 months that may alter the current study result
- After evaluation by the clinician, those currently or had previous treatment of atrophic acne scars with fillers, lasers, deep chemical peels, or any other medical or surgical treatment which in the investigators' opinion could alter the results of the current clinical study
- Those that are currently taking photo-sensitive drugs, oral isotretinoin, iron supplement or other herbal medication
- Those that have received laser treatment over the lesion area over the past 3 months
- Those that are currently pregnant or breastfeeding
- After evaluation by the clinician, and concluded underline epilepsy, area to be treated is under infection or ulceration, poor wound healing)
Sites / Locations
- HAUTE BEAUTÉ Skin & Vein ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
High energy
Low energy
Arm Description
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
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
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.
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
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
Subjects' satisfaction score rated in a 0 to 10 point scale
Subjects' satisfaction score rated in a 0 to 10 point scale
Full Information
NCT ID
NCT04648995
First Posted
November 24, 2020
Last Updated
May 31, 2021
Sponsor
Haute Beauté Skin & Vein Clinic
Collaborators
Lumenis Be Ltd., Taipei Medical University Shuang Ho Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04648995
Brief Title
TheTreatment of Acne Scar Using UltraPulse CO2 Laser
Official Title
A Single-Blinded Split Face Prospective Study Comparing Different Energy, Efficacy, and Safety of UltraPulse CO2 Laser in the Treatment of Acne Scar Using Antera Quantitative 3D Image Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
September 8, 2021 (Anticipated)
Study Completion Date
November 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haute Beauté Skin & Vein Clinic
Collaborators
Lumenis Be Ltd., Taipei Medical University Shuang Ho Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scar
Keywords
UltraPulse CO2 Laser, Antera Quantitative 3D Image, Collagen, Elastic fiber, Scale for global severity of facial acne scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High energy
Arm Type
Other
Arm Description
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
Arm Title
Low energy
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
High energy (UltraPulse)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Low energy (UltraPulse)
Intervention Description
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
Primary Outcome Measure Information:
Title
Topographic volume changes of acne scars from baseline one month and three month after the 2nd treatment session
Description
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
Title
Histological change in epidermal/dermal component including elastic fiber and collagen synthesis three month after the 2nd treatment session from baseline
Description
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
Secondary Outcome Measure Information:
Title
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
Description
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
Title
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
Description
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
Title
Compare the difference of newly synthesis collagen and elastic fiber through staining in the low versus high energy treated arm
Description
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
Title
Assess the frequency and severity of encountered side effects in the low versus high energy treated arm
Description
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
Title
Subjects' satisfaction score rated in a 0 to 10 point scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects have to be aged from 20 to 60 year-old
Subjects currently have an area of involvement approximately 2cm × 2cm on each side of the face over the temples or cheek bone area
Classified as mild to moderate acne scar according to global severity of facial acne scar (GSAAS) score
After evaluation by clinician, those subjects to be treated with "Lumenis"CO2 Laser System (UltraPulse) can benefit from this laser treatment
Subjects need to be fully functional and aware of the pros and cons of the study. Subject is capable to make self judgement and sign the inform consent under his/her own will
Others: Have fully understand about this study and is willing to cooperate with the instruction of the study
Exclusion Criteria:
Those who were known to have keloid formation
Those who have porphyria or known photosensitivity
Those who previously underwent laser therapy treatment or skin biopsy and have showed poor result or adverse effect
Those who were classified as "severe" according to GSAAS system
Those who have bleeding tendency
Those who present with clinical data suggesting abnormal platelet function or coagulation disorder (such as prolonged aPTT or PT)
Those that are currently taking anticoagulants or anti-platelet drugs
Those who are on aspirin or other NSAIDs
Those who have history of granulomatous or connective tissue disease
Female subjects with a positive pregnancy test
Women who refuse to stay on effective contraception or refuse pregnancy tests during the study
After evaluation by the clinician, those that have been enrolled in clinical studies over the past 6 months that may alter the current study result
After evaluation by the clinician, those currently or had previous treatment of atrophic acne scars with fillers, lasers, deep chemical peels, or any other medical or surgical treatment which in the investigators' opinion could alter the results of the current clinical study
Those that are currently taking photo-sensitive drugs, oral isotretinoin, iron supplement or other herbal medication
Those that have received laser treatment over the lesion area over the past 3 months
Those that are currently pregnant or breastfeeding
After evaluation by the clinician, and concluded underline epilepsy, area to be treated is under infection or ulceration, poor wound healing)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuo-Liang Cheng, MD
Phone
+886-28787-2112
Email
dermacarl@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Donald Liu, MBChB, PhD
Phone
+886-22249-0088
Ext
2387
Email
16308@s.tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuo-Liang Cheng, MD
Organizational Affiliation
Haute Beauté Skin & Vein Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
HAUTE BEAUTÉ Skin & Vein Clinic
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Lai
Phone
+886-2-8787-2112
Email
clinklj@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25296739
Citation
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.
Results Reference
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31531167
Citation
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.
Results Reference
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PubMed Identifier
11423843
Citation
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.
Results Reference
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PubMed Identifier
31985622
Citation
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. Erratum In: Plast Reconstr Surg. 2020 May;145(5):1341.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Emer J. Platelet-Rich Plasma (PRP): Current Applications in Dermatology. Skin Therapy Lett. 2019 Sep;24(5):1-6.
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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Citation
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.
Results Reference
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Learn more about this trial
TheTreatment of Acne Scar Using UltraPulse CO2 Laser
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