Article type : Original Article

Accepted Article
Novel device-based acne treatments: comparison of a 1,450-
nm diode laser and micro-needling radiofrequency on mild to
moderate acne vulgaris and seborrhea in Korean patients
through a 20-week prospective, randomized, split-face study

H. H. Kwon,1 H. Y. Park,1 S. C. Choi,1 Y. Bae,2 J. Y. Jung,1 G.-H. Park2

1
Oaro Dermatology Clinic, Seoul, Korea
2
Department of Dermatology, Dongtan Sacred Heart Hospital, Hallym University
College of Medicine, Hwaseong, Korea

• Running head: diode laser vs microneedle radiofrequency for acne

• Key words: diode laser, microneedle radiofrequency, laser surgery, acne

• Correspondence

Gyeong-Hun Park, MD, PhD

Department of Dermatology, Dongtan Sacred Heart Hospital, Hallym University
College of Medicine, 7, Keunjaebong-gil, Hwaseong-si, Gyeonggi-do 18450,
Republic of Korea

This article has been accepted for publication and undergone full peer review but has not
been through the copyediting, typesetting, pagination and proofreading process, which may
lead to differences between this version and the Version of Record. Please cite this article as
doi: 10.1111/jdv.14714

This article is protected by copyright. All rights reserved.

 Telephone: 82-31-8086-2839, Fax: 82-31-8086-2638, E-mail:
borelalgebra@gmail.com
Accepted Article
Jae Yoon Jung, MD, MS
Oaro Dermatology Clinic, 507, Nohaero, Nowongu, Seoul 01695, Republic of
Korea
Telephone: 82-2-930-1500, Fax: 82-2-930-0015, E-mail:
jaeyoon007@hanmail.net

• Running Conflict of Interest: None declared

• Funding source: None

Abstract

Background: While device-based acne treatments are widely applied for patients
not tolerating conventional medications, related controlled studies have been still
limited. Recently, non-ablative 1,450-nm diode laser (DL) and fractional micro-
needling radiofrequency (FMR) have been effectively used for acne, in addition to
well-recognized dermal remodeling effects.

Objective: To compare the clinical course for acne treatment between DL and FMR.

Methods: Twenty five Korean patients with mild to moderate facial acne completed
treatments with DL and FMR through a 20-week, randomized split-face study. One
randomly assigned half side of each patient’s face received DL and the other side by
FMR. Treatments were scheduled to receive three consecutive sessions at 4-week
intervals. Objective assessments including revised Leeds grades, lesion counts,
sebum output measurements, and patients’ subjective satisfaction were investigated.

Results: Both DL and FMR demonstrated steady improvement of acne and

seborrhea during treatment sessions. While results between two devices were
similar during treatment sessions, FMR was superior to DL in the 12-week follow up.
Patients’ subjective assessments for seborrhea improvement were similar between

This article is protected by copyright. All rights reserved.

 two devices, while those for acne, skin texture, and acne scars were more
satisfactory for FMR. For safety proflie, no significant difference was observed
between two regimens, while mild post inflammatory hyperpigmentation was
Accepted Article
observed only in DL side.

Conclusion: Both DL and FMR demonstrated efficacies for acne and seborrhea,
with reasonable safety proflie. FMR was more effective than DL for the long-term
maintenance, and subjective assessments for texture and scar improvements.
Therefore, a few sessions of these devices would be a viable option for acne
treatments.

Introduction

Four major pathogenic factors leading to acne include follicular dyskeratization,

excessive sebum, Propionibacterium acnes, and inflammation.1, 2 Current anti-acne

treatment modalities suppress these targets. While pharmacological therapies such

as antibiotics and retinoids are the mainstays of treatment, they commonly require

long-term administration and accompany various side effects.3 Additionally,

considering high prevalence of acne, a substantial proportion of acne patients with

underlying internal diseases, sensitive skin, and preparing for pregnancy could not

readily tolerate these medications. With a growing medical demand for device-based

treatments, light-based therapies including pulse dye laser, blue light, and intense

pulsed light have provided some clinical benefits.4-8

Recently, non-ablative 1,450-nm diode laser (DL) and fractional micro-needling

radiofrequency (FMR) have been effectively used for various acne lesions and

hyperseborrhea, in addition to well-recognized their dermal remodeling effects.9, 10

DL, with its wavelength in the infrared range, induces thermal damage to the mid-

dermal skin layer, where sebaceous glands are located. The concurrent

This article is protected by copyright. All rights reserved.

 incorporation of dynamic cooling device protects the epidermis from thermal

damage.11 FMR delivers bipolar radiofrequency directly to the dermis using an array
Accepted Article
of microneedles.12 It has been reported to improve skin laxity, wrinkles, and acne

scarring with epidermal preservation with a rapid recovery time.13, 14 Its effect on

active acne lesions has been also reported through a few studies.15

Despite novel introduction of these two devices with potential clinical utilities in

the acne treatment field, a direct comparison of therapeutic courses between them in

a controlled fashion has not been performed yet. In this study, we aimed to evaluate

the efficacy and safety for acne and seborrhea treatments based on DL and FMR

during three consecutive sessions through a prospective, randomized split-face

comparison study.

Methods
 Study design

This study was designed as a 20-week, prospective, randomized split-face

protocol that compared clinical courses between two facial sides either receiving DL

or FMR for acne vulgaris. At the initial presentation, the evaluation of the acne

severity by revised Leeds grade and individual acne lesion counts were performed

for all enrolled patients. Then, each facial side of every patient was randomly

assigned into either DL or FMR treatment side. A random allocation sequence was

created using computer-based random number generators to assign the treatment

modality of each side. Randomization codes were secured in a safe until all data

analyses were finished. Treatments of each side were scheduled to receive three

consecutive sessions at 4-week intervals, with a follow-up visit at 12 weeks after the

final third treatment. Evaluations of the each treatment sessions were performed

This article is protected by copyright. All rights reserved.

 after 1 week of every treatment. Two dermatologists evaluating acne severities were

blinded to the assignment. At patients’ each evaluation visit, photographic

Accepted Article
assessments by dermatologists, sebum secretion measurement, and patients’

subjective assessments were conducted.

 Subjects

This study was conducted in accordance with the Declaration of Helsinki and was

approved by the Institutional Review Board. Informed consents were acquired from

all subjects prior to enrollments. Twenty-six participants (aged 19-37 years, 16

female and 10 male, 14 Fitzpatrick skin type III and 12 type IV) with mild to moderate

acne vulgaris as defined by revised Leeds score 2 to 7 (mean 4.4 ± 0.9) participated

in this study.16 Subjects were not allowed to use any systemic, topical, or light-based

acne treatment during the course of this study. The exclusion criteria were

pregnancy, mental illness, intake of oral isotretinoin within 3 months, and application

of the other oral and topical acne medications, chemical peeling and light based

treatments within 6 weeks. Baseline information is described in Table 1.

 Devices and treatment protocols

According to the randomly assigned allocation, one half of the face was treated

with DL (ART laserTM, DM company, Seongnam, Republic of Korea), and the other

half with FMR device (SecretTM, Ilooda, Suwon, Republic of Korea). For local

anesthesia, the face was cleansed with a mild soap and 70% alcohol, and a topical

eutectic mixture of 2.5% lidocaine hydrochloric acid and 2.5% prilocaine

(AstraZeneca AB, Sodertalje, Sweden) was applied to the entire face under

occlusion 30 minutes before treatments. For the DL treatment, each half facial area

This article is protected by copyright. All rights reserved.

 was administered two passes with the stamp mode, which comprised of 4 micro-

pulses lasting a total of 250 milliseconds with five cryogen spurts interspersed lasting
Accepted Article
a total of 35-40 milliseconds. The fluence of laser ranged from 7-12 J/cm2 depending

on patients’ condition and anatomic locations at the discretion of the operator. For

FMR, treatment parameters were adjusted in the opposite half as follows: 0.8- to 2.0-

mm microneedle penetrating depth, 20 to 50 intensity, and 50- to 100-millisecond

duration with 2 to 3 passes in FMR device. As post-operative regimen, all patients

applied facial cooling mask with a soothing aloe gel just after finishing the procedure

for 15 minutes.

 Clinical outcome assessments

Objective acne severity assessments were conducted using individual lesion

counts (inflammatory lesions: papules, pustules, and nodules; non-inflammatory

lesions: open and closed comedones) and Leeds revised acne grading. Two

dermatologists not involved in treatments performed clinical evaluations. To ensure

the reliability of our evaluation, standardized digital photographs were also taken at

baseline and each follow-up visit using identical camera settings (Nikon D70, Nikon

Corp., Tokyo, Japan). To measure the sebum output level, both cheeks (the most

prominent area of the zygoma) were selected for measurement areas. At least 5

hours after washing the face with soap, sebum was collected from each site on a

plastic Sebumeter strip (Skin-O-Mat, Cosmomed GmbH, Wetter, Germany) using a

constant pressure for 30 seconds. After the face had been washed, further face

washing, use of cosmetics or any other topical products were not permitted until

assessments. Patient’s subjective assessments of satisfaction were also recorded at

the final visit. A subjective improvement scale was evaluated for the improvement of

This article is protected by copyright. All rights reserved.

 acne, seborrhea, skin textures/enlarged facial pores, and acne scar using a 5-point

scale (0 = no improvement, 1 = slight improvement, 2 = moderate improvement, 3 =

Accepted Article
good improvement, and 4 = excellent improvement). Subjects also recorded the

post-treatment responses including erythema, and edema with a 0-to-3 severity

scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). Other severe side effects,

and changes (hyperpigmentation, secondary scarring, and infection) were

documented during treatment sessions in detail. The overall duration of subjective

downtime that patients felt that treatment meaningfully affected their quality of life

was also recorded from each patient.

 Statistical analysis

The paired t-test or Wilcoxon signed-rank test and the McNemar test were used to

compare the differences between before and after treatment and those between DL

and FMR treatment sides (R version 3.3.1, The R Foundation for Statistical

Computing, Vienna, Austria). A p-value < 0.05 was considered as statistically

significant.

Results

Of the 26 patients who were initially enrolled, 25 (15 women and 10 men, aged

19-37 years; 13 Fitzpatrick skin type III and 12 type IV) patients completed the study;

one patient withdrew for personal reasons. No patient withdrew secondary to

treatment-related adverse events.

This article is protected by copyright. All rights reserved.

  Evaluation of acne counts

For inflammatory acne lesion counts, both sides demonstrated significant

Accepted Article
improvement during three sessions of each treatment. At the final 12-week follow-up

visit, the counts were decreased by 39.3% (from 14.5 to 9.5) in the DL side, and

58.2% (from 15.6 to 6.0) in the FMR side, the difference of which was significant (P <

0.05). No significant difference between two regimens was observed until receiving

the third session, and mean reductions of inflammatory lesions were observed after

the first session in both sides (P < 0.05) (Fig. 1a). Non-inflammatory acne lesions

were reduced on the DL side (27.5%, from 22.8 to 16.5, P < 0.05) after the third

session, also at the same point (33.2%, from 23.1 to 15.4, P < 0.05) on the FMR

side. The difference of improvements in mean lesion counts between two regimens

was evident only at the follow up visit (P < 0.05) (Fig. 1b).

 Assessment of general acne severity and sebum secretion

While there was no difference in the severity grading between the two sides at

baseline (4.5 ± 0.8 vs. 4.3 ± 0.9; P > 0.05), statistical differences in Leeds revised

acne grades between different treatment sides were observed at the final follow-up

visit, consistent with results of acne counts. For the FMR, the mean acne grade was

significantly decreased to 2.0 at the final visit, and that of DL was to 3.1 (Fig. 2a) (P

< 0.05). Figure 2b represents clinical photographs that illustrate improvements on

the DL side and relatively better improvements on the FMR side. Both sides

demonstrated gradual decreases in sebum output with significant reductions after

the second session, and notable differences between two sides was observed at the

follow up visit (P < 0.05) (Fig. 3).

This article is protected by copyright. All rights reserved.

  Patients’ subjective evaluations

Patients’ self-assessments for the degree of acne improvements generally

Accepted Article
paralleled physicians’ evaluation. Patients’ mean scores evaluated at the follow up

visit for hyperseborreha were 2.1 ± 0.8 at the FMR side and 2.2 ± 0.9 at the DL side,

respectively (P > 0.05). On the other hand, degrees of improvements for acne, skin

texture/enlarged pores, and atrophic acne scars were better in FMR side compared

with DL side (2.8 ± 1.1 vs. 2.1 ± 1.3 (P < 0.05) for acne; 2.5 ± 0.8 vs. 1.8 ± 1.1 (P <

0.05) for skin texture/enlarged pores; 2.9 ± 1.1 vs. 1.9 ± 1.8 (P < 0.05) for atrophic

acne scars) (Fig. 4).

 Safety profile

Various treatment-related side effects were thoroughly compared between two

sides from each patient. No significant difference was observed for post-treatment

erythema and edema between two sides (P > 0.05). While post-inflammatory

hyperpigmentation was not observed in the FMR side, 2 cases with mild, localized

pigmentations were observed in the DL side. No case of secondary scarring, and

infection was observed throughout the study. The average duration of downtime that

patients subjectively believe that treatment itself meaningfully affects their quality of

life was 1.6 ± 1.5 days for FMR side, and 1.5 ± 1.1 days for the DL side, which was

not significantly different (P > 0.05). Detailed information is shown in Table 2.

Discussion

To the best of our knowledge, this is the first study directly comparing diode laser

and radiofrequency device in the active acne treatment. While device-based acne

treatment can be widely applied not only as a monotherapy for patients not tolerating
This article is protected by copyright. All rights reserved.
 conventional medications but also as a component of combination therapy for

recalcitrant acne subtypes, related controlled studies with objective assessments

Accepted Article
have been still limited.

In this study, both DL and FMR demonstrated steady improvement of acne and

seborrhea during treatment sessions based on objective assessments. Compared

with other light based treatments, results of these two devices - about 50%

decreases of inflammatory lesions after 3 treatment courses - were generally

satisfactory.17-19 While results between two devices were similar during treatment

sessions, FMR was superior to DL in the follow up period. Maintaining improvement

for up to 3 months suggested potential advantages of FMR, as having prophylactic

effects against acne recurrence compared with DL. Patients’ subjective assessments

for acne and seborrhea improvement were similar between two devices, while those

for skin texture, enlarged pores, and acne scars were more satisfactory for FMR. For

safety profile, no significant difference was observed for adverse effects between two

regimens, while two cases of mild post-inflammatory hyperpigmentation were

observed only in DL side.

DL was initially designed for non-ablative improvement of skin texture by

stimulating procollagen production; meanwhile, histologic evaluation of treated skin

demonstrated coincidental damage to sebaceous glands.20, 21 At 1,450-nm

wavelength, water is the principal chromophore and the penetration depth of the

laser is approximately 200 ㎛.22 The presumed mechanism in vivo is through heating

of the sebaceous gland and associated structures, subsequently leading to the

impairment of sebaceous gland activity and associated inflammation. Despite its

well-known efficacy for acne, its major limitation was the treatment-associated pain.

This article is protected by copyright. All rights reserved.

 Practically, the 1,450-nm laser is not being used in the United States because of the

amount of pain it caused patients. However, recent studies have shown that using
Accepted Article
relatively lower energy with a double-pass technique as applied in this study is as

effective, less painful, and better tolerated,23, 24, 25 and subsequent studies also

confirmed the findings.11, 26, 27 The level of pain of the double-pass, low-fluence DL

treatment has been reported to be moderate (visual analogue scale 4.8-5.3/10),23, 25

which is comparable to or lower than that of nonablative fractional laser widely

used.28 Consistent with these previous results, most patients participating in the

present study also reported moderate pain which was tolerable with topical

anesthesia, although it was not investigated in this study. Unlike the United States,

the 1,450-nm laser is currently being used in Korea, and the low-fluence regimen

seems to have been helpful in the continuous use of DL devices in Korea.

FMR delivers bipolar radiofrequency directly to the dermis with minimal

epidermal damage. Using the microneedle delivery system, it is possible to deliver

an exact amount of radiofrequency energy at intended depths depending on target

lesions. Heat produced by the radiofrequency device originates from electron

movement and conductivity of the target tissue.29-31 Since sebaceous lipids are

electrically resistant, appropriately inserted needles around sebaceous glands would

induce heat mainly around acne lesions through radiofrequency integrated circuits,

leading to the functional and structural damages. The microneedle itself also induces

secretion of growth factors and migration of adjacent cells.32 Prieto et al. reported

that the combination of pulsed light and radiofrequency reduces average areas of

sebaceous glands and perifollicular lymphocytic infiltration.33 Hantash et al. observed

increases in the levels of TGF-β, MMP, and HSP expression after fractional

radiofrequency treatment leading to neocollagenesis.32 These cytokine alternations

This article is protected by copyright. All rights reserved.

 not only lead to extracellular matrix formation but also affect sebaceous glands.

Collectively, these results can explain the effects of the FMR device on both scarring
Accepted Article
and active acne lesions. The level of pain induced by FMR treatment has been

reported to be moderate,29, 34 which is comparable to that of DL.23, 25 Despite the

pain, FMR is being widely used with topical anesthesia. Participants in this study

also experienced tolerable pain with only topical anesthesia.

While both devices are beneficial for improving acne and seborrhea, FMR

seems more effective in enhancing dermal environment based on this study.

Considering majority of acne patients has at least “minimal scars” affecting their

quality of life,35, 36 concurrent improvement of acne and scars through dermal

remodeling could be additional clinical advantages of FMR. Since energy absorption

of melanin pigment would be minimized compared with other laser based devices,

Asian patients may have less concern about the risk of hyperpigmentation by FMR

treatment.37, 38

There are some limitations in this study. First, all the participants enrolled in this

study had an identical ethnic background. Second, further studies may be needed to

search for optimized treatment parameters of both devices. Finally, future studies

regarding combination treatments between these devices and anti-acne medications

against severe acne would provide clinically interesting data.

In conclusion, both DL and FMR demonstrated efficacies for acne and seborrhea,

with reasonable safety profile. FMR was more effective than DL in the long-term

maintenance of the improvement of acne and seborrhea, and subjective

assessments for skin texture and scar improvements. Therefore, a few sessions of

these devices, as monotherapy or as an element of component of combination

therapy, would be a viable option for acne treatment.

This article is protected by copyright. All rights reserved.

 References

1. Williams HC, Dellavalle RP, Garner S. Acne vulgaris. Lancet 2012; 379: 361-372.
Accepted Article
2. Harper JC. An update on the pathogenesis and management of acne vulgaris. J

Am Acad Dermatol 2004; 51: S36-38.

3. Zaenglein AL, Pathy AL, Schlosser BJ et al. Guidelines of care for the

management of acne vulgaris. J Am Acad Dermatol 2016; 74: 945-973 e933.

4. Bogle MA, Dover JS, Arndt KA, Mordon S. Evaluation of the 1,540-nm

Erbium:Glass Laser in the Treatment of Inflammatory Facial Acne. Dermatol Surg

2007; 33: 810-817.

5. Jih MH, Kimyai-Asadi A. Laser treatment of acne vulgaris. Semin Plast Surg 2007;

21: 167-174.

6. Leheta TM. Role of the 585-nm pulsed dye laser in the treatment of acne in

comparison with other topical therapeutic modalities. J Cosmet Laser Ther 2009; 11:

118-124.

7. Orringer JS, Kang S, Hamilton T et al. Treatment of acne vulgaris with a pulsed

dye laser: a randomized controlled trial. JAMA 2004; 291: 2834-2839.

8. Wiegell SR, Wulf HC. Photodynamic therapy of acne vulgaris using methyl

aminolaevulinate: a blinded, randomized, controlled trial. Br J Dermatol 2006; 154:

969-976.

9. Jih MH, Friedman PM, Goldberg LH, Robles M, Glaich AS, Kimyai-Asadi A. The

1450-nm diode laser for facial inflammatory acne vulgaris: dose-response and 12-

month follow-up study. J Am Acad Dermatol 2006; 55: 80-87.

10. Konishi N, Endo H, Oiso N, Kawara S, Kawada A. Acne phototherapy with a

1450-nm diode laser: an open study. Ther Clin Risk Manag 2007; 3: 205-209.

This article is protected by copyright. All rights reserved.

 11. Darne S, Hiscutt EL, Seukeran DC. Evaluation of the clinical efficacy of the 1,450

nm laser in acne vulgaris: a randomized split-face, investigator-blinded clinical trial.

Accepted Article
Br J Dermatol 2011; 165: 1256-1262.

12. Alexiades-Armenakas M, Rosenberg D, Renton B, Dover J, Arndt K. Blinded,

randomized, quantitative grading comparison of minimally invasive, fractional

radiofrequency and surgical face-lift to treat skin laxity. Arch Dermatol 2010; 146:

396-405.

13. Hruza G, Taub AF, Collier SL, Mulholland SR. Skin rejuvenation and wrinkle

reduction using a fractional radiofrequency system. J Drugs Dermatol 2009; 8: 259-

265.

14. Lolis MS, Goldberg DJ. Radiofrequency in cosmetic dermatology: a review.

Dermatol Surg 2012; 38: 1765-1776.

15. Kim ST, Lee KH, Sim HJ, Suh KS, Jang MS. Treatment of acne vulgaris with

fractional radiofrequency microneedling. J Dermatol 2014; 41: 586-591.

16. Tan JK, Zhang X, Jones E, Bulger L. Correlation of photographic images from

the Leeds revised acne grading system with a six-category global acne severity

scale. J Eur Acad Dermatol Venereol 2013; 27: e414-419.

17. Noborio R, Nishida E, Kurokawa M, Morita A. A new targeted blue light

phototherapy for the treatment of acne. Photodermatol Photoimmunol Photomed

2007; 23: 32-34.

18. Asayama-Kosaka S, Akilov OE, Kawana S. Photodynamic Therapy with 5%

delta-Aminolevulinic Acid is Safe and Effective Treatment of Acne Vulgaris in

Japanese Patients. Laser Ther 2014; 23: 115-120.

This article is protected by copyright. All rights reserved.

 19. Tao SQ, Li F, Cao L et al. Low-Dose Topical 5-Aminolevulinic Acid

Photodynamic Therapy in the Treatment of Different Severity of Acne Vulgaris. Cell

Accepted Article
Biochem Biophys 2015; 73: 701-706.

20. Tanzi EL, Alster TS. Comparison of a 1450-nm diode laser and a 1320-nm

Nd:YAG laser in the treatment of atrophic facial scars: a prospective clinical and

histologic study. Dermatol Surg 2004; 30: 152-157.

21. Rogachefsky AS, Hussain M, Goldberg DJ. Atrophic and a mixed pattern of acne

scars improved with a 1320-nm Nd:YAG laser. Dermatol Surg 2003; 29: 904-908.

22. Paithankar DY, Ross EV, Saleh BA, Blair MA, Graham BS. Acne treatment with

a 1,450 nm wavelength laser and cryogen spray cooling. Lasers Surg Med 2002; 31:

106-114.

23. Uebelhoer NS, Bogle MA, Dover JS, Arndt KA, Rohrer TE. Comparison of

stacked pulses versus double-pass treatments of facial acne with a 1,450-nm laser.

Dermatol Surg 2007; 33: 552-559.

24. Bernstein EF. A pilot investigation comparing low-energy, double pass 1,450 nm

laser treatment of acne to conventional single-pass, high-energy treatment. Lasers

Surg Med 2007; 39: 193-198.

25. Bernstein EF. Double-pass, low-fluence laser treatment using a large spot-size

1,450 nm laser improves acne. Lasers Surg Med 2009; 41: 116-121.

26. Noborio R, Nishida E, Morita A. Clinical effect of low-energy double-pass 1450

nm laser treatment for acne in Asians. Photodermatol Photoimmunol Photomed

2009; 25: 3-7.

27. Wada T, Kawada A, Hirao A, Sasaya H, Oiso N. Efficacy and safety of a low-

energy double-pass 1450-nm diode laser for the treatment of acne scars. Photomed

Laser Surg 2012; 30: 107-111.

This article is protected by copyright. All rights reserved.

 28. Kroon MW, Wind BS, Beek JF et al. Nonablative 1550-nm fractional laser

therapy versus triple topical therapy for the treatment of melasma: a randomized
Accepted Article
controlled pilot study. J Am Acad Dermatol 2011; 64: 516-523.

29. Vejjabhinanta V, Wanitphakdeedecha R, Limtanyakul P, Manuskiatti W. The

efficacy in treatment of facial atrophic acne scars in Asians with a fractional

radiofrequency microneedle system. J Eur Acad Dermatol Venereol 2014; 28: 1219-

1225.

30. Fitzpatrick R, Geronemus R, Goldberg D, Kaminer M, Kilmer S, Ruiz-Esparza J.

Multicenter study of noninvasive radiofrequency for periorbital tissue tightening.

Lasers Surg Med 2003; 33: 232-242.

31. Ruiz-Esparza J, Gomez JB. Nonablative radiofrequency for active acne vulgaris:

the use of deep dermal heat in the treatment of moderate to severe active acne

vulgaris (thermotherapy): a report of 22 patients. Dermatol Surg 2003; 29: 333-339;

discussion 339.

32. Hantash BM, Ubeid AA, Chang H, Kafi R, Renton B. Bipolar fractional

radiofrequency treatment induces neoelastogenesis and neocollagenesis. Lasers

Surg Med 2009; 41: 1-9.

33. Prieto VG, Zhang PS, Sadick NS. Evaluation of pulsed light and radiofrequency

combined for the treatment of acne vulgaris with histologic analysis of facial skin

biopsies. J Cosmet Laser Ther 2005; 7: 63-68.

34. Naouri M, Mazer JM. Non-insulated microneedle fractional radiofrequency for the

treatment of scars and photoaging. J Eur Acad Dermatol Venereol 2016; 30: 499-

502.

This article is protected by copyright. All rights reserved.

 35. Hayashi N, Miyachi Y, Kawashima M. Prevalence of scars and "mini-scars", and

their impact on quality of life in Japanese patients with acne. J Dermatol 2015; 42:
Accepted Article
690-696.

36. Layton AM, Henderson CA, Cunliffe WJ. A clinical evaluation of acne scarring

and its incidence. Clin Exp Dermatol 1994; 19: 303-308.

37. Gold MH, Biron JA. Treatment of acne scars by fractional bipolar radiofrequency

energy. J Cosmet Laser Ther 2012; 14: 172-178.

38. Hantash BM, Renton B, Berkowitz RL, Stridde BC, Newman J. Pilot clinical study

of a novel minimally invasive bipolar microneedle radiofrequency device. Lasers

Surg Med 2009; 41: 87-95.

Figure legends
Fig. 1. Percent changes of (a) inflammatory acne lesion counts, and (b) non-

inflammatory acne lesion counts during time window of treatment sessions and the

final follow up. FMR: fractional micro-needling radiofrequency; DL: diode laser. BL:

baseline; PT: post-treatment; F/u: follow-up. * P < 0.05 versus baseline; † P < 0.05

between DL and FMR sides.

Fig. 2. (a) Changes in the general severity levels measured by Leeds revised acne

grading system of the two sides. FMR: fractional micro-needling radiofrequency; DL:

diode laser. BL: baseline; PT: post-treatment; F/u: follow-up. * P < 0.05 versus

baseline; † P < 0.05 between DL and FMR sides. (b) Photographs of the FMR side

(1, 3) and DL side (2, 4) at baseline and after 12-week lapse of the final treatments.

Clinical improvements were observed on both sides, but the degree of improvement

was higher on the FMR side.

This article is protected by copyright. All rights reserved.

 Fig. 3. Changes in sebum output level with time. FMR: fractional micro-needling

radiofrequency; DL: diode laser. BL: baseline; PT: post-treatment; F/u: follow-up. * P
Accepted Article
< .05 versus baseline; † P < .05 between DL and FMR sides.

Fig. 4. Patients’ subjective assessments at the final follow up visit for the

improvement of (a) acne, (b) seborrhea, (c) skin texture/enlarged pores, and (d)

atrophic acne scar using a 5-point scale (0 = no improvement, 1 = slight

improvement, 2 = moderate improvement, 3 = good improvement, and 4 = excellent

improvement) between two regimens.

This article is protected by copyright. All rights reserved.

 Tables
Table 1. Baseline information of enrolled patients in this study
Accepted Article
Patients’ clinical characteristics

Number 26

Age (yr) 23.4 ± 7.8 (19-37)

Sex (F/M) 16/10

Skin phototype (III/IV) 14/12

Non-inflammatory lesions 45.9 ± 16.5

Inflammatory lesions 30.1 ± 6.7

Leeds revised scale 4.4 ± 0.9

This article is protected by copyright. All rights reserved.

 Table 2. Safety profile of each facial side treated by either DL or FMR regimen

during treatment sessions.

Accepted Article
DL FMR Analysis

Erythema 1.3 ± 0.8 1.5 ± 0.6 P > 0.05

(0-3 scale)

Edema 0.9 ± 0.5 1.1 ± 0.6 P > 0.05

(0-3 scale)

Pigmentary 2/25 None P > 0.05

changes

Scar formation None None NA

Secondary None None NA

infection

Average duration 1.5 ± 1.1 1.6 ± 1.5 P > 0.05

of downtime

(days)

DL: diode laser; FMR: fractional micro-needling radiofrequency; NA: Not available.

This article is protected by copyright. All rights reserved.

Accepted Article

This article is protected by copyright. All rights reserved.

Accepted Article

This article is protected by copyright. All rights reserved.

Accepted Article

This article is protected by copyright. All rights reserved.