Comparison of 1,550-nm Laser and Fractional Radiofrequency Microneedle for the Treatment of Acne Scars in Ethnic Skin

NCT03380845 | Completed Results FDA Device

• 1 other identifier: 2017P002061
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this randomized, split-face, controlled study is to compare the efficacy and safety of a erbium-doped 1,550-nm non-ablative fractional laser and a bipolar fractional radiofrequency microneedle device for the treatment of atrophic facial acne scars in ethnic skin (Fitzpatrick Skin Phototypes III-VI). The hypothesis of this study is that both erbium-doped 1,550-nm non-ablative fractional laser and the bipolar fractional radiofrequency microneedle device are equally effective for the treatment of atrophic acne scars in ethnic skin (SPT III-VI). However, the bipolar fractional radiofrequency microneedle device has less adverse effects than erbium-doped 1,550-nm non-ablative fractional laser due to the absence of scattering and the absence of chromophore-specific targets - predominantly melanin - traditionally needed with laser treatments; hence the fractional radiofrequency microneedle device will have a higher safety profile in darker skin types .

Conditions

Acne Scars

Outcome Measures

Primary Outcomes (1)

• Improvement in Acne Scarring - From Baseline to Three Months After Last Treatment

  Improvement in acne scarring will be measured by two blinded evaluators both by in-person assessments and by photographic review (digital photography will be used under standardized conditions). A quartile grading scale (1 = 1% to 25%, 2 =26% to 50%, 3 =51% to 75%, 4 = \>76% improvement) will be used to measure acne scar improvement. Higher score means better outcome.

  three months after last treatment

Secondary Outcomes (2)

• Comparing Side Effects of the Different Lasers

  treatment visit 1, treatment visit 2, treatment visit 3, three months after last treatment

• Comparing Intensity of Pain With the Different Lasers

  treatment visit 1, treatment visit 2, treatment visit 3

Study Arms (2)

Fraxel Restore on one side of the face

ACTIVE COMPARATOR

Fraxel Restore on one side of the face Fraxel Restore: acne scar correction Randomized treatment with Fraxel Restore on one side of the face, and Fractora on the opposite side of the face - the study is a randomized,single-center, split-face study in subjects seeking acne scar correction. Subjects were treated with Fraxel on one side of the face and Fractora on the other side of the face. The side of the face for each device was randomly assigned.

Device: Fraxel Restore

Fractora on the other side of the face

ACTIVE COMPARATOR

Fractora on the other side of the face Fractora: acne scar correction Randomized treatment with Fraxel Restore on one side of the face, and Fractora on the opposite side of the face - the study is a randomized,single-center, split-face study in subjects seeking acne scar correction. Subjects were treated with Fraxel on one side of the face and Fractora on the other side of the face. The side of the face for each device was randomly assigned.

Device: Fractora

Interventions

Fraxel Restore DEVICE

Non-ablative Laser. In the study, one side of the face will be treated with Fraxel Restore monthly for three months.

Fraxel Restore on one side of the face

Fractora DEVICE

Fractional Radiofrequency Microneedling Device. In the study, one side of the face will be treated with Fractora monthly for three months.

Fractora on the other side of the face

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with Fitzpatrick skin types III through VI and facial acne scarring of grades III-IV will be enrolled. Both sides of the participants' face should have almost similar amount and severity of acne scarring. Participants will be over 18 years old

You may not qualify if:

• Patients have to be overall healthy without a history of keloidal scarring, localized or active infection in the treatment region, immunodeficiency disorders, porphyria or light sensitivity, and connective tissue disorders. Per PI discretion, any serious medical condition that may interfere with the study. In addition, pregnant or nursing women, patients who have been taking isotretinoin for a period of 6 months before treatment, and patients who have received any cosmetic treatment (lasers, dermabrasion, chemical peels, etc) in the previous 6 months will be excluded. Also, patients with renal disease, and any allergies to Lidocaine, Tetracaine, or Valtrex will be excluded.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Society for Dermatologic Surgery: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (10)

• Purvis D, Robinson E, Merry S, Watson P. Acne, anxiety, depression and suicide in teenagers: a cross-sectional survey of New Zealand secondary school students. J Paediatr Child Health. 2006 Dec;42(12):793-6. doi: 10.1111/j.1440-1754.2006.00979.x.

  PMID: 17096715 BACKGROUND

• Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.

  PMID: 15216537 BACKGROUND

• Alster TS, Tanzi EL, Lazarus M. The use of fractional laser photothermolysis for the treatment of atrophic scars. Dermatol Surg. 2007 Mar;33(3):295-9. doi: 10.1111/j.1524-4725.2007.33059.x.

  PMID: 17338686 BACKGROUND

• Chrastil B, Glaich AS, Goldberg LH, Friedman PM. Second-generation 1,550-nm fractional photothermolysis for the treatment of acne scars. Dermatol Surg. 2008 Oct;34(10):1327-32. doi: 10.1111/j.1524-4725.2008.34284.x.

  PMID: 19040687 BACKGROUND

• Mahmoud BH, Srivastava D, Janiga JJ, Yang JJ, Lim HW, Ozog DM. Safety and efficacy of erbium-doped yttrium aluminum garnet fractionated laser for treatment of acne scars in type IV to VI skin. Dermatol Surg. 2010 May;36(5):602-9. doi: 10.1111/j.1524-4725.2010.01513.x. Epub 2010 Apr 1.

  PMID: 20384757 BACKGROUND

• Alexis AF, Coley MK, Nijhawan RI, Luke JD, Shah SK, Argobi YA, Nodzenski M, Veledar E, Alam M. Nonablative Fractional Laser Resurfacing for Acne Scarring in Patients With Fitzpatrick Skin Phototypes IV-VI. Dermatol Surg. 2016 Mar;42(3):392-402. doi: 10.1097/DSS.0000000000000640.

  PMID: 26945321 BACKGROUND

• Hruza G, Taub AF, Collier SL, Mulholland SR. Skin rejuvenation and wrinkle reduction using a fractional radiofrequency system. J Drugs Dermatol. 2009 Mar;8(3):259-65.

  PMID: 19271373 BACKGROUND

• Chandrashekar BS, Sriram R, Mysore R, Bhaskar S, Shetty A. Evaluation of microneedling fractional radiofrequency device for treatment of acne scars. J Cutan Aesthet Surg. 2014 Apr;7(2):93-7. doi: 10.4103/0974-2077.138328.

  PMID: 25136209 BACKGROUND

• Chae WS, Seong JY, Jung HN, Kong SH, Kim MH, Suh HS, Choi YS. Comparative study on efficacy and safety of 1550 nm Er:Glass fractional laser and fractional radiofrequency microneedle device for facial atrophic acne scar. J Cosmet Dermatol. 2015 Jun;14(2):100-6. doi: 10.1111/jocd.12139. Epub 2015 Mar 23.

  PMID: 25810322 BACKGROUND

• Abdel Hay R, Shalaby K, Zaher H, Hafez V, Chi CC, Dimitri S, Nabhan AF, Layton AM. Interventions for acne scars. Cochrane Database Syst Rev. 2016 Apr 3;4(4):CD011946. doi: 10.1002/14651858.CD011946.pub2.

  PMID: 27038134 BACKGROUND

Results Point of Contact

• Title: Dr. Sandeep Saluja
• Organization: MGH

sandeep.s.saluja@gmail.com

6466621084

Study Officials

• Mathew Avram, MD

  MGH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, MGH Laser, Cosmetic and Dermatologic Surgery

Model Details: Randomized split-face clinical trial

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 21, 2017
• Study Start: March 16, 2018
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: November 19, 2019
• Results First Posted: November 19, 2019

Record last verified: 2019-11

Locations

US (1)