TheTreatment of Acne Scar Using UltraPulse CO2 Laser

NCT04648995 | Unknown

• 1 other identifier: N202007052
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Scar

Keywords

UltraPulse CO2 Laser; Antera Quantitative 3D Image; Collagen; Elastic fiber; Scale for global severity of facial acne scar

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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

  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

  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

  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

  from baseline and three month after the 2nd treatment session

• 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

Study Arms (2)

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

Device: High energy (UltraPulse)

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

Device: Low energy (UltraPulse)

Interventions

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

High energy

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

Low energy

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haute Beauté Skin & Vein Clinic: lead
• Lumenis Be Ltd.: collaborator
• Taipei Medical University Shuang Ho Hospital: collaborator

Study Sites (1)

HAUTE BEAUTÉ Skin & Vein Clinic

Taipei, 110, Taiwan

RECRUITING

Related Publications (9)

• 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.

  PMID: 25296739 BACKGROUND

• 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.

  PMID: 31531167 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.

  PMID: 11423843 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.

  PMID: 31985622 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.

  PMID: 31413476 BACKGROUND

• Emer J. Platelet-Rich Plasma (PRP): Current Applications in Dermatology. Skin Therapy Lett. 2019 Sep;24(5):1-6.

  PMID: 31584784 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.

  PMID: 31496020 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.

  PMID: 31478266 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.

  PMID: 29512189 BACKGROUND

Study Officials

• Kuo-Liang Cheng, MD

  Haute Beauté Skin & Vein Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuo-Liang Cheng, MD

CONTACT

+886-28787-2112; dermacarl@hotmail.com

Donald Liu, MBChB, PhD

CONTACT

+886-22249-0088; 16308@s.tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Superintendent

Model Details: 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

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: December 11, 2020
• Primary Completion: September 8, 2021
• Study Completion: November 28, 2021
• Last Updated: June 3, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)