Original Contribution Journal of Cosmetic Dermatology, 15, 102--107
The efficacy and safety of combined microneedle fractional radiofrequency and sublative fractional radiofrequency for acne scars in Asian skin Jae Yang Park, MD, Eo Gin Lee, MD, Moon Soo Yoon, MD, & Hee Jung Lee, MD Department of Dermatology, CHA Bundang Medical Center, CHA University, Seongnam, Korea
Summary
Background Microneedle fractional radiofrequency has been reported to be effective for improving wrinkles, enlarged pores and various scars. Sublative fractional radiofrequency has been shown to induce both fractional ablation of epidermis and upper dermal remodelling, which had rejuvenation effects in photoaged skin. Both modalities may have the potential synergy to improve acne scars. Objective To evaluate the efficacy and safety of combined microneedle and sublative fractional radiofrequency for acne scars in Asian skin. Methods Twenty subjects comprised 11 males and 9 females (mean age 23.65 2.94, skin phototype III–IV) with moderate to severe acne scars. The subjects received three consecutive combined microneedle and sublative fractional radiofrequency at 4-week intervals over 12 weeks. Both blinded dermatologists and subjects assessed the clinical improvement based on the standardized photography and questionnaires, respectively. The quartile grading scale was utilized and defined as follows: grade 1, 0–25% improvement; grade 2, 26–50% improvement; grade 3, 51–75% improvement and grade 4, 76–100% improvement. Results All 20 subjects were assessed to have grade 2 or more clinical improvement by physicians; four (20%) had grade 4, 10 (50%) had grade 3, and six (30%) had grade 2 improvement. The subjects’ grading also showed a good concordance as indicated by Kappa index of 0.695. The mean duration of post-therapy crusting was 5.2 days and post-therapy erythema lasted 2.5 days. Conclusion Combined microneedle and sublative fractional radiofrequency can have a positive therapeutic effect with no serious complications and may provide a new therapeutic approach on acne scars in Asians. Keywords: acne scar, Asian, fractional radiofrequency
Introduction In the past few years, fractional radiofrequency (RF) has attracted a great deal of interest in the field of skin Correspondence: Hee Jung Lee, MD, Department of Dermatology, CHA Bundang Medical Center, CHA University, 59 Yatap-ro, Bundang-gu, Seongnam 463-712, Korea. E-mail: [email protected] Accepted for publication October 16, 2015
102
rejuvenation and scar treatment.1 Hantash et al.2 introduced a bipolar RF system with pairs of microneedles as the electrodes, which were inserted into the skin in a minimally invasive manner to deliver the RF energy directly into the dermis. This bipolar RF system generates fractional zones of electrothermal damage deep in the dermis, surrounded by areas of undamaged tissue under a more-or-less intact epidermis. These areas of damage in the dermal matrix
© 2015 Wiley Periodicals, Inc.
Combined fractional radiofrequency for acne scars
induced a vigorous wound healing process supported by the surrounding undamaged tissue and lead to the synthesis of new collagen and elastin, dermal remodelling and replenishment of hyaluronic acid.1–3 Microneedle fractional RF also showed improvement of acne scars and large facial pores with less adverse events than fractional lasers.4,5 However, moderate to severe acne scars showing superficial irregularities require multiple sessions of microneedle fractional RF treatment for effective improvement. The term “sublative” is the derivative of “sub-ablative”, referring to the ability not only to ablate the superficial epidermis but also to generate thermal energy in a “pyramid” shape under the ablated epidermal zone.6 As sublative RF is capable of improving superficial irregularities with minimal downtime, and microneedling RF with insulated microneedles can create precise areas of deep dermal damage to improve the condition of the dermal matrix, conjoining these two approaches could offer a synergistic efficacy in the treatment of acne scars. This study was therefore undertaken to evaluate in vivo the efficacy and safety of combined microneedle fractional RF and sublative fractional RF treatment for acne scars in the Asian skin type.
Table 1 Patient demographics, history and assessment scores
Case no.
Sex/Age
1
M/19
2 3 4
F/24 M/31 F/21
5
F/28
6 7 8 9
M/24 M/25 M/23 F/20
10
F/24
11
M/27
12 13
F/23 M/25
14 15
F/22 M/25
16
F/20
Methods
17 18
F/22 M/23
Subjects
19
M/26
20
M/21
The trial subjects for this prospective study comprised 11 males and 9 females with Fitzpatrick Skin Type III/ IV and moderate to severe atrophic facial acne scars. Patient ages ranged from 19 to 31, with an average age of 22.65. Patient characteristics are summarized in Table 1. The exclusion criteria were: (1) patients with the use of topical retinoids during the 8 weeks prior to the study, (2) those who had taken oral isotretinoin during the 6 months prior to the study, (3) those with history of any resurfacing procedures, chemical reconstruction of skin scars (CROSS) using trichloroacetic acid, collagen induction therapy using a microneedle therapy system and non-ablative fractional photothermolysis treatment within the preceding 6 months, (4) those with history of keloid formation, (5) those with active eczema, pregnancy and lactation in women. The study protocol and informed consent form were submitted and approved by the CHA University Institutional Review Board. All 20 subjects were informed of the benefits, risks and possible complications of the treatment before enrollment, and informed consent was obtained from each patient.
© 2015 Wiley Periodicals, Inc.
. J Y Park et al.
Type of scar Rolling, Boxcar Rolling Rolling Rolling, Icepick, Boxcar Rolling, Boxcar Rolling Rolling Rolling Rolling, Boxcar Rolling, Boxcar Rolling, Boxcar Icepick Rolling, Icepick, Boxcar Icepick Boxcar, Icepick Boxcar, Icepick Rolling Rolling Rolling, Boxcar Boxcar
Previous treatment (no.)
Physician grade*
Patient grade*
None
4
4
None None Chemical peel (2)
3 3 2
3 3 2
FPS (4)
3
4
IPL (3) None None IPL (2)
3 3 4 4
3 4 4 4
None
2
3
Chemical peel (3) MDA (3) None
3
3
2 2
2 2
None IPL (3)
2 3
2 3
None
2
2
None Chemical peel (3) IPL (3)
4 3
4 3
3
3
None
3
4
FPS, non-ablative 1550-nm erbium-doped fractional photothermolysis system; IPL, intense pulsed light; MDA, crystal microdermabrasion. *Physician/Patient grading scale: grade 1, 0–25%, minimal to no improvement; grade 2, 26–50%, moderate improvement; grade 3, 51–75%, marked improvement; grade 4, 76–100%, near total improvement.
Description of devices
We used a dual mode fractional RF device (InfiniTM; Lutronic Co., Goyang-si, Korea), which has both a microneedle fractional RF handpiece with a single-use disposable tip consisting of 49 insulated microneedle electrodes over an area of 1 cm2 and a sublative fractional RF handpiece with a single-use disposable tip consisting of 144 electrodes in an area of 4 cm2. The 200 lm-thick microneedle electrodes were insulated, leaving 300 lm active at the very tip of the needles. Electrothermal damage was therefore confined to the needle tips in the dermis, leaving the epidermis
103
Combined fractional radiofrequency for acne scars
. J Y Park et al.
unharmed. The depth of the inserted needles could be adjusted by the user from 0.5 to 3.5 mm in 500 lm increments below the skin surface. For both the microneedling fractional RF (MFR) and superficial fractional RF (SFR) handpieces, the RF energy was delivered at a frequency of 1 MHz. The output power was adjustable from level 1 to 20 (2.5–50 W in 2.5 W increments) with exposure times ranging from 10 to 1000 ms in 100 ms increments. Treatment protocols
Subjects received three consecutive combined MFR and SFR treatments at 4-week intervals over 12 weeks. The face was anesthetized using topical 4% lidocaine cream (LMX4; Ferndale Laboratories Inc., Ferndale, MI, USA) about 30 min before the procedure. Then it was cleaned with facial foam cleanser and 70% alcohol. MFR was performed first and the treatment settings were needle depth of 1.5 mm; level 7; and 50 ms exposure time. SFR was applied next and the treatment settings were level 16–17; and 70–80 ms exposure. An epidermal cooling device (Caresys; Danil SMC Co., Seongnam-si, Korea) was used to relieve pain and erythema after the treatment. Subjects were allowed to apply their own UVA/B SPF >30 sunscreen or emollients but were prohibited from using any kind of retinoid or antibiotic before and during the study period, including the follow-up. Clinical assessments
Patients were assessed at baseline and 8 weeks after the final treatment. Photographs by digital camera (Nikon D90, Tokyo, Japan) were obtained at each visit. Objective clinical assessments were performed by two blinded dermatologists independent to the study, based on the before- and after-clinical photography. Clinical improvements included reduction in number and extent of scars, in depth of scars and in unevenness of colour.7 In addition, acne scars were divided into three subgroups, such as rolling, boxcar and icepick scars to see, if any, different treatment responses according to their morphology. The degree of clinical improvement, when assessed using the aforementioned criteria, was determined on a quartile grading scale (grade 0, no improvement; grade 1, 1–25% = minimal improvement; grade 2, 26–50% = moderate improvement; grade 3, 51– 75% = marked improvement; and grade 4, 76–100% = near total improvement).8 Eight weeks after the final treatment, the subjects were asked to grade their improvement subjectively using the same quartile grad-
104
ing scale. Subjects were also asked to report the extent and duration of post-procedural side effects including bleeding, oozing, scaling or crusting, post-inflammatory hyperpigmentation (PIH) and erythema. Statistical analysis
The results were statistically analyzed to reveal significant clinical improvements using the Wilcoxon signed-rank test. Kappa statistic was utilized to measure interobserver variation. All statistical analyses were performed using the SPSS software (version 12.0; SPSS Inc., Chicago, IL, USA). P-values of
The efficacy and safety of combined microneedle fractional radiofrequency and sublative fractional radiofrequency for acne scars in Asian skin Jae Yang Park, MD, Eo Gin Lee, MD, Moon Soo Yoon, MD, & Hee Jung Lee, MD Department of Dermatology, CHA Bundang Medical Center, CHA University, Seongnam, Korea
Summary
Background Microneedle fractional radiofrequency has been reported to be effective for improving wrinkles, enlarged pores and various scars. Sublative fractional radiofrequency has been shown to induce both fractional ablation of epidermis and upper dermal remodelling, which had rejuvenation effects in photoaged skin. Both modalities may have the potential synergy to improve acne scars. Objective To evaluate the efficacy and safety of combined microneedle and sublative fractional radiofrequency for acne scars in Asian skin. Methods Twenty subjects comprised 11 males and 9 females (mean age 23.65 2.94, skin phototype III–IV) with moderate to severe acne scars. The subjects received three consecutive combined microneedle and sublative fractional radiofrequency at 4-week intervals over 12 weeks. Both blinded dermatologists and subjects assessed the clinical improvement based on the standardized photography and questionnaires, respectively. The quartile grading scale was utilized and defined as follows: grade 1, 0–25% improvement; grade 2, 26–50% improvement; grade 3, 51–75% improvement and grade 4, 76–100% improvement. Results All 20 subjects were assessed to have grade 2 or more clinical improvement by physicians; four (20%) had grade 4, 10 (50%) had grade 3, and six (30%) had grade 2 improvement. The subjects’ grading also showed a good concordance as indicated by Kappa index of 0.695. The mean duration of post-therapy crusting was 5.2 days and post-therapy erythema lasted 2.5 days. Conclusion Combined microneedle and sublative fractional radiofrequency can have a positive therapeutic effect with no serious complications and may provide a new therapeutic approach on acne scars in Asians. Keywords: acne scar, Asian, fractional radiofrequency
Introduction In the past few years, fractional radiofrequency (RF) has attracted a great deal of interest in the field of skin Correspondence: Hee Jung Lee, MD, Department of Dermatology, CHA Bundang Medical Center, CHA University, 59 Yatap-ro, Bundang-gu, Seongnam 463-712, Korea. E-mail: [email protected] Accepted for publication October 16, 2015
102
rejuvenation and scar treatment.1 Hantash et al.2 introduced a bipolar RF system with pairs of microneedles as the electrodes, which were inserted into the skin in a minimally invasive manner to deliver the RF energy directly into the dermis. This bipolar RF system generates fractional zones of electrothermal damage deep in the dermis, surrounded by areas of undamaged tissue under a more-or-less intact epidermis. These areas of damage in the dermal matrix
© 2015 Wiley Periodicals, Inc.
Combined fractional radiofrequency for acne scars
induced a vigorous wound healing process supported by the surrounding undamaged tissue and lead to the synthesis of new collagen and elastin, dermal remodelling and replenishment of hyaluronic acid.1–3 Microneedle fractional RF also showed improvement of acne scars and large facial pores with less adverse events than fractional lasers.4,5 However, moderate to severe acne scars showing superficial irregularities require multiple sessions of microneedle fractional RF treatment for effective improvement. The term “sublative” is the derivative of “sub-ablative”, referring to the ability not only to ablate the superficial epidermis but also to generate thermal energy in a “pyramid” shape under the ablated epidermal zone.6 As sublative RF is capable of improving superficial irregularities with minimal downtime, and microneedling RF with insulated microneedles can create precise areas of deep dermal damage to improve the condition of the dermal matrix, conjoining these two approaches could offer a synergistic efficacy in the treatment of acne scars. This study was therefore undertaken to evaluate in vivo the efficacy and safety of combined microneedle fractional RF and sublative fractional RF treatment for acne scars in the Asian skin type.
Table 1 Patient demographics, history and assessment scores
Case no.
Sex/Age
1
M/19
2 3 4
F/24 M/31 F/21
5
F/28
6 7 8 9
M/24 M/25 M/23 F/20
10
F/24
11
M/27
12 13
F/23 M/25
14 15
F/22 M/25
16
F/20
Methods
17 18
F/22 M/23
Subjects
19
M/26
20
M/21
The trial subjects for this prospective study comprised 11 males and 9 females with Fitzpatrick Skin Type III/ IV and moderate to severe atrophic facial acne scars. Patient ages ranged from 19 to 31, with an average age of 22.65. Patient characteristics are summarized in Table 1. The exclusion criteria were: (1) patients with the use of topical retinoids during the 8 weeks prior to the study, (2) those who had taken oral isotretinoin during the 6 months prior to the study, (3) those with history of any resurfacing procedures, chemical reconstruction of skin scars (CROSS) using trichloroacetic acid, collagen induction therapy using a microneedle therapy system and non-ablative fractional photothermolysis treatment within the preceding 6 months, (4) those with history of keloid formation, (5) those with active eczema, pregnancy and lactation in women. The study protocol and informed consent form were submitted and approved by the CHA University Institutional Review Board. All 20 subjects were informed of the benefits, risks and possible complications of the treatment before enrollment, and informed consent was obtained from each patient.
© 2015 Wiley Periodicals, Inc.
. J Y Park et al.
Type of scar Rolling, Boxcar Rolling Rolling Rolling, Icepick, Boxcar Rolling, Boxcar Rolling Rolling Rolling Rolling, Boxcar Rolling, Boxcar Rolling, Boxcar Icepick Rolling, Icepick, Boxcar Icepick Boxcar, Icepick Boxcar, Icepick Rolling Rolling Rolling, Boxcar Boxcar
Previous treatment (no.)
Physician grade*
Patient grade*
None
4
4
None None Chemical peel (2)
3 3 2
3 3 2
FPS (4)
3
4
IPL (3) None None IPL (2)
3 3 4 4
3 4 4 4
None
2
3
Chemical peel (3) MDA (3) None
3
3
2 2
2 2
None IPL (3)
2 3
2 3
None
2
2
None Chemical peel (3) IPL (3)
4 3
4 3
3
3
None
3
4
FPS, non-ablative 1550-nm erbium-doped fractional photothermolysis system; IPL, intense pulsed light; MDA, crystal microdermabrasion. *Physician/Patient grading scale: grade 1, 0–25%, minimal to no improvement; grade 2, 26–50%, moderate improvement; grade 3, 51–75%, marked improvement; grade 4, 76–100%, near total improvement.
Description of devices
We used a dual mode fractional RF device (InfiniTM; Lutronic Co., Goyang-si, Korea), which has both a microneedle fractional RF handpiece with a single-use disposable tip consisting of 49 insulated microneedle electrodes over an area of 1 cm2 and a sublative fractional RF handpiece with a single-use disposable tip consisting of 144 electrodes in an area of 4 cm2. The 200 lm-thick microneedle electrodes were insulated, leaving 300 lm active at the very tip of the needles. Electrothermal damage was therefore confined to the needle tips in the dermis, leaving the epidermis
103
Combined fractional radiofrequency for acne scars
. J Y Park et al.
unharmed. The depth of the inserted needles could be adjusted by the user from 0.5 to 3.5 mm in 500 lm increments below the skin surface. For both the microneedling fractional RF (MFR) and superficial fractional RF (SFR) handpieces, the RF energy was delivered at a frequency of 1 MHz. The output power was adjustable from level 1 to 20 (2.5–50 W in 2.5 W increments) with exposure times ranging from 10 to 1000 ms in 100 ms increments. Treatment protocols
Subjects received three consecutive combined MFR and SFR treatments at 4-week intervals over 12 weeks. The face was anesthetized using topical 4% lidocaine cream (LMX4; Ferndale Laboratories Inc., Ferndale, MI, USA) about 30 min before the procedure. Then it was cleaned with facial foam cleanser and 70% alcohol. MFR was performed first and the treatment settings were needle depth of 1.5 mm; level 7; and 50 ms exposure time. SFR was applied next and the treatment settings were level 16–17; and 70–80 ms exposure. An epidermal cooling device (Caresys; Danil SMC Co., Seongnam-si, Korea) was used to relieve pain and erythema after the treatment. Subjects were allowed to apply their own UVA/B SPF >30 sunscreen or emollients but were prohibited from using any kind of retinoid or antibiotic before and during the study period, including the follow-up. Clinical assessments
Patients were assessed at baseline and 8 weeks after the final treatment. Photographs by digital camera (Nikon D90, Tokyo, Japan) were obtained at each visit. Objective clinical assessments were performed by two blinded dermatologists independent to the study, based on the before- and after-clinical photography. Clinical improvements included reduction in number and extent of scars, in depth of scars and in unevenness of colour.7 In addition, acne scars were divided into three subgroups, such as rolling, boxcar and icepick scars to see, if any, different treatment responses according to their morphology. The degree of clinical improvement, when assessed using the aforementioned criteria, was determined on a quartile grading scale (grade 0, no improvement; grade 1, 1–25% = minimal improvement; grade 2, 26–50% = moderate improvement; grade 3, 51– 75% = marked improvement; and grade 4, 76–100% = near total improvement).8 Eight weeks after the final treatment, the subjects were asked to grade their improvement subjectively using the same quartile grad-
104
ing scale. Subjects were also asked to report the extent and duration of post-procedural side effects including bleeding, oozing, scaling or crusting, post-inflammatory hyperpigmentation (PIH) and erythema. Statistical analysis
The results were statistically analyzed to reveal significant clinical improvements using the Wilcoxon signed-rank test. Kappa statistic was utilized to measure interobserver variation. All statistical analyses were performed using the SPSS software (version 12.0; SPSS Inc., Chicago, IL, USA). P-values of
