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

NCT ID: NCT03380845

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-16
• Study Completion Date: 2018-10-30

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 .

Detailed Description

Acne is a highly prevalent disease and post-acne scaring has shown to have detrimental effects on a person's physical, mental, and social well-being. Acne scars can be divided in general categories of hypertrophic or keloid scars, atrophic scars (icepick, rolling, boxcar), and pigmentation alterations (redness, hypo and hyper-pigmentation). This study will focus on treatment of moderate to severe grades of atrophic acne scarring. Our aim 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 acne scars in ethnic skin (Fitzpatrick Skin Phototypes III-VI) by performing a split-face randomized controlled trial.

Both devices in this study are already FDA approved treatment modalities for acne scarring.

History of erbium-doped 1,550-nm non-ablative fractional laser (Fraxel® Restore Laser System, Solta Medical, Inc., Hayward, CA):

Non-ablative fractional lasers work via the theory of fractional photothermolysis, which creates hundreds to thousands of microscopic thermal zones (MTZs), or columns of thermally injured skin, while sparing the surrounding tissue. The pixilated nature of treatment and the functionally unimpaired stratum corneum allow for rapid tissue healing and allows for safer treatments of our patients. Mechanistically, fractional photothermolysis allows controlled amounts of high energy to be delivered deep within the dermis resulting in collagenolysis and neocollagenesis, which smoothes the textural abnormalities of acne scarring.

Multiple published studies have demonstrated that erbium-doped 1,550-nm non-ablative fractional laser ("NAFL") can be successfully utilized in the treatment of all forms of atrophic acne scarring - ice-pick, boxcar, and rolling scars - with a very favorable safety profile in all skin types, and thus, has been cleared by Food and Drug Administration (FDA) for that particular indication. According to the manufacture manual (reference attached in the "Attachments" section), NAFL is indicated for "use in skin resurfacing procedures as well as treatment of acne scars, surgical scars, lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma."

History of the fractional radiofrequency microneedle device (Fractora; Invasix Ltd./InMode MD Ltd., Israel):

Fractional radiofrequency is not a laser. Instead, these devices use an array of electrodes that allows for zones of thermal wounds to be created between areas of unaffected zones, thus stimulating dermal remodeling and allowing for a supply of reservoir cells to promote healing. Variations of fractional radiofrequency exist that employ microneedles to deliver electrical current to a particular depth within the dermis that decreases damage to the epidermis. These fractional radiofrequency microneedle devices provide an alternative to conventional methods of acne-scar treatment (such as NAFL). Great interest has been culminating over the recent years for the use of such devices in acne scars due to the absence of light scattering and the absence of chromophore-specific targets traditionally needed with laser treatments. As melanin is not a target, it is felt to have a higher safety profile in darker skin phototypes.

A recent study investigated the safety and efficacy of a specific bipolar fractional radiofrequency microneedle device (Fractora; Invasix Ltd./InMode MD Ltd., Israel) for acne and acne scarring. In this study, 8 patients with acne scars were reported and it was noted that all patients (regardless of their skin phototypes) had improvement in their active acne and acne scars after 4 treatments and a 1 month, on average follow-up period. The treatment was well tolerated without any side-effects. Skin biopsies from this study showed reduction in scar depth and new collagen formation with an increase in elastic fibers and adnexal structures noted. A follow-up report showed that 4 out of 8 patients who were in the original study returned for a long term follow-up from 1 to 2 years, that showed ongoing clinical improvements in these patients. This specific bipolar fractional radiofrequency microneedle ("FRM") device has been FDA-approved for acne scars and skin rejuvenation.

To this date the efficacy and safety of 1,550-nm fractionated photothermolysis system has not been compared to a fractional radiofrequency microneedle device for atrophic acne scars in ethnic skin in a randomized split-face controlled trial. A major advantage of a split-face self-controlled design would be to minimize any confounding factors. Laser resurfacing has been well studied and is widely used in individuals with fair skin - Fitzpatrick skin phototypes (SPT) I to II. However, there is a paucity of published studies involving individuals with darker skin types (SPT III-VI)-a population that has a higher risk of laser-associated dyspigmentation.

Conditions

Acne Scars

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fraxel Restore on one side of the face

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.

Group Type: ACTIVE_COMPARATOR

Fraxel Restore

Intervention Type: DEVICE

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

Fractora on the other side of the face

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.

Group Type: ACTIVE_COMPARATOR

Fractora

Intervention Type: DEVICE

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

Interventions

Fraxel Restore

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

Intervention Type: DEVICE

Fractora

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Society for Dermatologic Surgery

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mathew Avram, MD, JD

Director, MGH Laser, Cosmetic and Dermatologic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mathew Avram, MD

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17096715 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15216537 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17338686 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19040687 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20384757 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26945321 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19271373 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25136209 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25810322 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27038134 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017P002061

Identifier Type: -

Identifier Source: org_study_id