Pulsed Wave Mode of Fractional Radiofrequency Microneedling as a New Advance in the Treatment of Inflammatory Acne Vulgaris

Abstract

Inflammatory acne vulgaris (IAV) is a common skin condition characterized by the presence of reddish, inflamed, and painful lesions on the skin. IAV can drastically affect individuals, specifically their self-esteem, psychological health, and quality of their life in general. Despite new advances in the field, traditional treatment modalities withstand many challenges. Hence, in the current study, we sought to assess the efficacy and safety of a new pulsed wave mode of the fractional microneedling radiofrequency device in the treatment of IAV. This advanced technique employs insulated microneedles to administer energy to the deep dermis without causing damage to the epidermis. Eighty patients (40 males, 40 females, age 21 ± 3, Fitzpatrick skin type III and IV), with acne severity ranging from moderate to severe, were employed in this trial. They were randomly assigned into two groups, 40 patients each. The treated group (A) underwent four sessions of fractionated microneedle RF, 1.5-month apart, whereas group B was designated as the control group that received placebo treatment. Six months following the last session, the degree of improvement assessed by the quantity of IAV lesions and the overall skin appearance in terms of facial pores, sebum excretion, scar, skin tone, and texture. The RF-treated group showed significant improvement compared to the control group after the follow-up period (p-value = 0.0071). Regarding safety, very mild adverse effects were reported, such as discomfort during the session, pinpoint hemorrhage, and erythema, with no major side effects such as burns, scarring, hyperpigmentation, or hypopigmentation were reported. Thus, our data suggest a potential role of the fractional microneedling radiofrequency device in IAV treatment that is both effective and safe.

1. Introduction

Acne vulgaris is a prevalent skin condition [1] that results in a combination of factors, such as the overproduction of sebum, clogged pores caused by dead skin cells, and bacterial proliferation, especially the presence of propionibacterium acne and hormonal imbalances [2,3]. There are two categories of acne lesions: comedonal lesions, which consist of whiteheads and blackheads, as well as inflammatory lesions, which include papules, pustules, nodules, and cysts. Acne typically affects body regions with sebaceous glands such as the face, chest, back, and shoulders [4,5].

The primary objectives of the treatment modalities that are currently available for inflammatory acne vulgaris (IAV) include the following [6]. Pharmaceutical interventions, including topical antibiotics, topical retinoids, oral antibiotics and oral retinoids, are the primary treatments [7,8]. However, they frequently require long-term use and may be linked with substantial adverse effects, including the development of P. acnes strains that are resistant to antibiotics and xerosis along with other adverse effects linked to retinoids [9,10]. Acne vulgaris has been increasingly treated with nonpharmacologic modalities, either alone or in conjunction with medical therapeutic interventions [11,12,13,14,15].

Even though laser or light therapy is typically employed to address acne scarring rather than active inflammatory lesions [16], the safety and effectiveness of a diverse array of laser and light devices (e.g., intense pulsed light, a nonablative 1450 nm diode laser and the pulsed dye laser) were reported with the intention for the management of IAV. It appears that pulsed dye lasers are capable of eliminating P. acnes. Laser energy is absorbed by hemoglobin, which in turn decreases vascularity and modulates the inflammatory process that is linked to acne [4,13,14,15]. The thermal injury directly applied to the sebaceous glands and the subsequent decrease in the secretion of sebum are the defining characteristics of the impact of nonablative 1450 nm diode lasers on acne vulgaris [4,12,15]. Inflamed acne vulgaris that is moderate to severe has also been effectively treated with nonablative radiofrequency (RF) devices [1,9]. It was proposed that the primary mechanism of action for nonablative radiofrequency is the promotion of dermal architecture remodeling and the reduction in sebaceous gland activity through thermal stimulation, specifically thermotherapy [17].

The pulsed wave mode of fractional microneedling radiofrequency is an innovative treatment that integrates the advantages of radiofrequency (RF) radiation and microneedling. The pulsed wave mode emits RF energy in the form of multiple pulses. The body’s natural healing response is triggered by the microneedling, which creates microscopic incisions in the skin. Subsequently, the microneedles deliver radiofrequency energy, which heats the deeper layers of the skin and stimulates collagen production. The microneedles induce controlled micro-injuries in the epidermis and dermis, which activate the body’s wound-healing response. Meanwhile, the deeper skin layers are heated by the radiofrequency energy, which aids in the reduction in inflammation, the eradication of acne-causing bacteria, and the stimulation of collagen production. Improving the appearance of existing acne lesions and preventing the development of new ones are the benefits of this combination [18].

Cho et al.’s study show that the number and severity of purulent cutaneous lesions, such as IAV, were clinically improved in the majority of patients following the application of an ablative 10,600 nm fractional carbon dioxide laser treatment [19]. In our study, we demonstrated, through a prospective examination of clinical photographs and the duration of post-therapy recovery and adverse effects, the efficacy and safety of the pulsed wave mode of fractionated microneedle radiofrequency appliance in 40 Iraqi patients with active IAV lesions.

2. Methods

2.1. Patients

In this prospective observational study, eighty patients (40 males, 40 females; average age 21 ± 3, range 16–28; Fitzpatrick skin type III and IV) with moderate to severe inflammatory acne vulgaris (IAV).

Table 1. Characteristics of the patients.

Characteristics	RF Group	Control Group
Total patients	40 (100%)	40 (100%)
Male	20 (50%)	20 (50%)
Female	20 (50%)	20 (50%)
Age (years)
Range	16–28 years	16–28 years
Mean ± SD	21 ± 3	21 ± 3
Fitzpatrick skin type
Type III	16 (40%)	19 (47.5%)
Type IV	24 (60%)	21 (52.5%)
Acne Vulgaris
Moderate	25 (62.5%)	25 (62.5%)
Severe	15 (37.5%)	15 (37.5%)
Duration of Acne
Range	3–15 years	3–15 years
Mean ± SD	8 ± 3	8 ± 3
Residency
Urban	37 (92.5%)	34 (85%)
Rural	3 (7.5%)	6 (15%)
Previous Topical Medication (before 6 months)	24 (60%)	26 (65%)
Previous Systemic Antibiotic (before 6 months)	19 (47.5%)	21 (52.5%)
Previous Systemic Retinoids (before 6 months)	4 (10%)	5 (12.5%)
Previous Laser and other energy-based therapies (before 6 months)	2 (5%)	1 (2.5%)

provides a summary of the patient characteristics. We randomly divided the patients into two groups, each of which contained 40 patients. Group A was treated with fractionated microneedle RF, while group B was designated as the control group, which received a placebo (the application of only distilled water). The two groups were similar in age, gender, and the severity of acne vulgaris. The patients included in this study were those with moderate to severe IAV, who did not complain about any hormonal cause that was confirmed by investigation and ultrasound, who did not receive any topical and/or systemic medications, or perform any laser and other energy-based therapies for acne in the last 6 months. This study did not include patients if they complained about any hormonal cause of acne, if they had received topical and/or systemic medications, or performed any laser and other energy-based therapies for acne in the last 6 months. Additionally, female patients who were at a significant risk of developing expectancy or those with a predisposition to immunosuppression or keloids were omitted.

2.2. Treatment Protocol

Four fractionated microneedle RF sessions (Sylfirm X, Viol, Seoul, Republic of Korea; Figure 1) were administered to patients at one and a half-month intervals. The face was cleansed with a mild soap and a concentration of 70% alcohol prior to the administration of local anesthetic. The entire face was placed under occlusion 1 h prior to laser therapy, and a topical 10.56% lidocaine hydrochloric acid (Austin Pharm. Co., Ltd., Seoul, Republic of Korea) was applied. Each treatment session included five passes with parameters as follows: pulsed wave 4 mode (PW4 mode); a 3 mm, 2 mm, 1.5 mm, 1 mm, 0.5 mm microneedle penetrating depth; a power level of 7, 6, 6, 6, 4, respectively; and an RF conduct time of 100/500/100 ms (off/on/off). Oral acyclovir (Aciclovir Tablets 400 mg, Actavis, Dublin, Ireland) was prophylactically prescribed to individual patients who have experienced a history of herpes virus infection for a period of three days. It was advised to apply a non-comedogenic moisturizer for a few days after each treatment session on a daily basis in order to prevent dehydration and promote wound healing. After the post-therapy crusting had subsided, patients were advised to avoid excessive sunlight exposure and the application of a broad-spectrum photoblock. Additionally, they were advised to refrain from administering any systemic or topical antibiotics or retinoids throughout the duration of the treatment.

2.3. Evaluation

The following methods were used in order to assess the consequences of treatment on the treated patients, both objectively and subjectively:

• A: Objective method:

The same camera settings, illumination, and patient positioning were employed to capture photographs at baseline and before each treatment sessions until 6 months following the last session. In a blinded manner, two dermatologists conducted objective clinical assessments via the comparison of before-and-after photographs in a non-chronological order. The mean improvement of both groups was calculated. The subsequent methodologies were implemented:

• The degree of improvement of the acne inflammatory lesions including the severity and number of the lesions were recorded separately to determine the improvement using a score, which was graded using a six-point scale and includes the following: grade 0 (indicates worsening of condition), grade 1 (failure indicates 0% improvement), grade 2 (mild indicates 1–25% improvement), grade 3 (moderate indicates 26–50% improvement), grade 4 (good indicates 51–75% improvement), grade 5 (excellent indicates 76–99% improvement), and grade 6 (perfect indicates 100% improvement).
• The degree of improvement of the overall skin pattern was assessed in terms of enlarged facial pores, sebum excretion, scar improvement, skin tone, and texture, which was graded using a six-point scale and includes the following: grade 0 (indicates worsening of condition), grade 1 (failure indicates 0% improvement, grade 2 (mild indicates 1–25% improvement), grade 3 (moderate indicates 26–50% improvement), grade 4 (good indicates 51–75% improvement), grade 5 (excellent indicates 76–99% improvement), and grade 6 (perfect indicates 100% improvement).

The investigators examined patients for potential adverse effects, such as erythema, scaling, crusting, dyschromia following therapy, oozing, and hemorrhage, during each visit, which occurred at 1 week, 1 month, and 1.5 month after each treatment session. There was an additional checkup for the incidence of any adverse effects six months following the last treatment session.

• B: Subjective methods:

This approach involves documenting the extent of patient satisfaction with respect to the improvement of the lesional area at the conclusion of treatment and at the end of the six-month follow-up period for each group. The degree of satisfaction was graded on a scale of 0 to 5, with a score of 0 indicating complete dissatisfaction and a score of 5 indicating complete satisfaction.

2.4. Statistical Analysis

Version 20 SPSS (Statistical Analysis for the Social Sciences) was employed for the statistical analysis in this study. Descriptive statistics employed numerical values, percentages, means, ranges, and standard errors. The independent sample t-test and paired sample t-test were implemented for conducting an analysis of the data. A p-value of less than 0.05 was considered statistically significant.

3. Results

Eighty patients completed the treatment sessions and the six month follow-up period, including forty patients who underwent the RF treatment sessions and forty patients given a placebo that were regarded as a control group. The RF-treated group included forty patients (20 males, 20 females; mean age 21 ± 3, range 16–28), the skin type distribution according to Fitzpatrick.

Comprising 16 patients with type III and 24 patients with type IV, the acne vulgaris severity was distributed as follows: a total of 25 patients complained about moderate severity, and 15 patients complained about severe inflammatory acne vulgaris (IAV). Meanwhile, the control group included forty patients (20 males, 20 females; mean age 21 ± 3, range 16–28), and the skin type distribution according to Fitzpatrick comprised 19 patients with type III and 21 patients with type IV. The acne vulgaris severity was distributed as follows: a total of 25 patients complained about moderate severity and 15 patients complained about severe IAV. Previous use of topical medications, systemic antibiotics, systemic retinoids, and previous sessions of laser and other energy-based therapies that were taken by the participants before 6 months of starting this study were all determined (See Table 1).

The degree of improvement regarding the quantity of acne lesions that are inflammatory and were assessed six months subsequent to the final treatment revealed that fourteen of forty patients in the RF-treated group who had grade six clinical improvement, eleven patients showed grade five, eight patients showed grade four, while five patients showed grade three and two patients showed grade two improvement, with no patients showing worsening of the inflammatory lesions or failed to experience improvement upon the conclusion of the follow-up period. Meanwhile, in the control group, five out of forty participants showed a worsening of the inflammatory acne lesions, twenty-two participants failed to obtain improvement, eleven participants showed grade 2 improvement and two participants showed grade 3 improvement upon the conclusion of the follow-up period. The disparity revealed tremendously consequential differences between the control group and the RF-treated group regarding the degree of improvement of the inflammatory lesions of acne vulgaris upon the conclusion of the follow-up period. (p-value = 0.0143). (See

Table 2. Degree of improvement of the inflammatory lesions of acne vulgaris.

Grade of Improvement	RF Group No. (%)	Control Group No. (%)	p Value
Grade 0 (indicate worsening of condition)	0 (0 %)	5 (12.5%)	0.0143
Grade 1 (failure indicate 0% improvement)	0 (0%)	22 (55%)
Grade 2 (mild indicate 1–25% improvement)	2 (5%)	11 (27.5%)
Grade 3 (moderate indicate 26–50% improvement)	5 (12.5%)	2 (5%)
Grade 4 (good indicate 51–75% improvement)	8 (20%)	0 (0%)
Grade 5 (excellent indicate 76–99% improvement)	11 (27.5%)	0 (0%)
Grade 6 (perfect indicate 100% improvement)	14 (35%)	0 (0%)
Total	40 (100%)	40 (100%)

, Figure 2, Figure 3 and Figure 4) (See Supplementary Materials Figures S1–S3).

The overall skin pattern in terms of enlarged facial pores, sebum excretion, scar improvement, skin tone, and texture were improved, in which eight of forty patients in the RF-treated group had grade 6 clinical improvement, fifteen patients showed grade 5, eight patients showed grade 4, while five patients showed grade 3 and four patients showed grade 2 improvement, with none of the patients showing a worsening of the overall skin pattern or failing to obtain improvement at the end of the follow-up period. Meanwhile, in the control group, four of forty participants showed a worsening of the overall skin pattern, thirty-one participants failed to obtain improvement, four participants showed grade 2 improvement and one participant showed grade 3 improvement upon the conclusion of the follow-up period. There was a highly considerable difference between the control group and the RF-treated group regarding the degree of improvement of the overall skin pattern upon the conclusion of the follow-up period. (p-value = 0.0071) (See

Table 3. Degree of improvement of the overall skin pattern.

Grade of Improvement	RF Group No. (%)	Control Group No. (%)	p Value
Grade 0 (indicate worsening of condition)	0 (0%)	4 (10%)	0.0071
Grade 1 (failure indicate 0% improvement)	0 (0%)	31 (77.5%)
Grade 2 (mild indicate 1–25% improvement)	4 (10%)	4 (10%)
Grade 3 (moderate indicate 26–50% improvement)	5 (12.5%)	1 (2.5%)
Grade 4 (good indicate 51–75% improvement)	8 (20%)	0 (0%)
Grade 5 (excellent indicate 76–99% improvement)	15 (37.5%)	0 (0%)
Grade 6 (perfect indicate 100% improvement)	8 (20%)	0 (0%)
Total	40 (100%)	40 (100%)

, Figure 5).

In general, the adverse effects were minimum; the most severe complaint was pain during treatment. In patients with severe pain for which the topical anesthetics were insufficient, the nerve blockade was beneficial in alleviating pain. Some patients complained from transient bleeding during the treatment sessions, especially when the procedure was conducted with a depth setting of 2 mms or deeper, but this bleeding stopped quickly with an application of a dry gauze pad for few seconds. Edema, erythema, crusting, and seeping from the treated sites after the treatment occurred in most treated patients improved spontaneously in less than 1 week. Major side effects like burns, scarring, hyperpigmentation, and hypopigmentation were not observed.

After the follow-up period, the patient satisfaction score revealed a statistically significant difference in the severity of the inflammatory lesions of acne vulgaris and the overall skin pattern between the control group and the RF-treated group. The majority of the RF-treated patients were highly satisfied and observed a remarkable difference in the degree of improvement of the inflammatory lesions of acne vulgaris and the overall skin pattern in comparison to the control group upon the conclusion of the follow-up period with a highly considerable difference between the two groups (p-value = 0.0167) (See

Table 4. The patients’ satisfaction scores concerning the degree of hair color restoration among transplanted follicles in the recipient area.

Grade of Satisfaction	RF Group No. (%)	Control Group No. (%)	p Value
Grade 0 (completely unsatisfied)	0 (0%)	26 (65%)	0.0167
Grade 1 (1–25% satisfaction)	1 (2.5%)	11 (27.5%)
Grade 2 (26–50% satisfaction)	2 (5%)	3 (7.5%)
Grade 3 (51–75% satisfaction)	7 (17.5%)	0 (0%)
Grade 4 (76–99% satisfaction)	14 (35%)	0 (0%)
Grade 5 (complete satisfaction)	16 (40%)	0 (0%)
Total	40 (100%)	40 (100%)

).

4. Discussion

In the current study, we demonstrated that patients treated with the pulsed wave mode of the fractional microneedling radiofrequency device (RF) showed significant improvement when compared to the control group at the end of the follow-up period (p = 0.0071). This improvement is represented by a reduction in the inflammatory acne lesion, along with better appearance of the skin in general, such as a decrease in enlarged facial pores, sebum excretion, scar visibility, and improvement in skin tone and texture.

Adverse effects in RF-treated patients were minimal. Minimal pain was frequently reported during the procedure. However, it did not require treatment discontinuation. Other side effects, such as pinpoint hemorrhage and transient erythema, were reported and resolved without treatment. Significantly, no major adverse effects were reported, such as burns, scarring, hyperpigmentation, or hypopigmentation, which highlights the safety of this advancement.

Fractional photothermolysis targets 20–30% of epidermal and dermal tissue by dividing a single laser beam into a series of microbeams [20]. Therefore, the recovery period is brief, and there are fewer side effects than with conventional treatment [21,22]. Fractional photothermolysis was accomplished through the utilization of RF radiation emitted by microneedles in this study. Each microneedle has a diameter of 100–200 μm, and the Sylfirm X Tips contains 25 microneedles per cm². This minimizes the injury to the epidermis caused by the microneedle, thereby reducing the formation of crust and reducing the recovery time [18].

Radiofrequency-based devices have been employed to treat a variety of dermatologic conditions, such as inflammatory acne lesions, vascular lesions, rosacea, hypertrophic scars, and atrophic scars, along with wrinkles [7,12]. The mechanisms by which these devices operate are believed to be associated with the absorption of RF energy by water, collagen, melanin, and dermal microvasculature. This process results in a bulk heating effect on the dermis and the secretion of cellular mediators and growth factors, which then leads to wound healing [23]. The new iteration of fractionated microneedling radiofrequency has a new mode known as the pulsed wave mode (PW), which emits RF energy in the form of multiple short pulses. And the traditional mode, known as the continuous wave (CW), emits RF energy as a single, sustained pulse that is delivered for a predetermined duration. The PW mode resulted in selective coagulation, because the skin’s highly conductive tissues reacted to the delivery of RF energy in the form of pulses, thereby selectively affecting microvascular components, tiny blood vessels, or the basement membrane. In contrast, the continuous delivery of RF energy to the skin in CW mode resulted in non-selective coagulation of the skin tissue surrounding the microneedle. When treating inflammatory acne vulgaris (IAV), it was discovered that the PW mode yielded superior results compared to the CW mode [18]. To our knowledge, this is the first study to assess the efficacy and safety of new RF pulsed wave mode in the treatment of IAV.

A previous study investigated the application of fractionated microneedle radiofrequency in 18 Korean patients for the treatment of IAV. They used the traditional CW mode and found that the fractionated microneedle RF has the potential to have a beneficial therapeutic impact on acne vulgaris that is inflammatory and its associated scarring. Furthermore, this method does not exacerbate active acne lesions [24]. Meanwhile, in our study, we used the new PW mode, which provided superior therapeutic beneficial effects with lesser adverse effects.

The fractional RF microneedling was administered to 25 patients with moderate to severe acne, using the traditional CW mode. The safety and effectiveness of the method were evaluated by employing objective parameters, and it was shown that the fractional RF microneedling is a safe and effective treatment for acne vulgaris [25].

Other studies showed that non-ablative radiofrequency (RF) was a safe and effective treatment for moderate to severe acne vulgaris. This study reports that a majority of participants (80%) who underwent nonablative RF treatments showed significant improvement with no significant side effects observed. This study proposed that an RF-based system stimulates dermal architecture remodeling and inhibits sebaceous gland activity, which led to clinical enhancement in the treatment of inflammatory acne lesions [17].

The initial demonstration of the minimally invasive RF device, a bipolar microneedle electrode system, on human epidermis and dermis, was conducted by Hantash BM, et al. (2009). Using microneedle electrode pairs, the authors established thermal zones in the dermis that are generated by radiofrequency. A fractionated microneedle RF was employed in the current study to treat acne vulgaris that is inflammatory and its associated skin conditions, which include enlarged facial pores and acne scars. It is possible that the therapeutic effects of this device were the consequence of collagen induction by the embossing microneedles and heating of volumetric tissue through radiofrequency. In contrast to the previous report, the RF-instrument microneedle utilized within the current study was not insulated, whereas it was proximally insulated to safeguard the epidermis from radiofrequency radiation at the places of insertion. Adverse consequences that may occur of radiofrequency heating on the epidermis, such as postinflammatory hyperpigmentation, scarring, prolonged erythema, burning, and evident crusting were not observed when an RF device with non-insulated microneedles was employed. Rather, the epidermis exhibited therapeutic effects, particularly an improvement in texture [26].

Compared to laser-based fractional devices that are both ablative and nonablative, fractionated RF appears to offer a greater degree of deeper heat diffusion and volumetric heating. The release of numerous growth factors has been reported to induce the migration and proliferation of fibroblasts and keratinocytes through skin needle dermabrasion using microneedles [27]. Additionally, the realignment and regeneration of irregular and dense collagen bundles through physical breakage are facilitated by the creation of closer holes, which leads to improved skin scar and texture [28].

Our study illustrated the safety and efficacy of a pulsed wave mode of a fractional microneedling radiofrequency device regarding the management of acne lesions that are inflammatory. We believe that the combined effects of collagen induction and volumetric tissue heating by RF by the embossing microneedles are the primary advantages of therapy that employs this device in lieu of other therapies. The clinical improvement of inflammatory acne lesions may be achieved by the stimulation of follicular epithelial and dermal architecture remodeling and the inhibition of sebaceous gland activity, all these aids in the reduction in inflammation, the eradication of acne-causing bacteria, and the stimulation of collagen production. These changes may be achieved by improving the appearance of existing acne lesions and preventing the development of new lesions.

Our opinion that an RF device with fractionated microneedles is capable of delivering beneficial energy to skin tissues passing through microneedles in a more safe and effective manner than ablative 10,600 nm carbon dioxide fractional lasers or nonablative RF devices. In contrast to the ablative 10,600 nm carbon dioxide fractional laser treatment, the fractionated microneedle RF’s adverse effects, particularly the crusting and scale that occurs following therapy, were significantly less visible in our experience. Furthermore, the use of the RF device with fractionated microneedles in the patients with acne vulgaris that is inflammatory is considered safe due to the minimal risk of a long recuperation time, an extended period of erythema, edema, scarring, and dyschromias following therapy. However, prospective research should be performed to verify our findings in the future.

In the current study, the new pulsed wave mode of fractional RF microneedling was administered to 40 patients with moderate to severe IAV. Adverse effects, subjective satisfaction score, sebum excretion, the count of acne lesions that are inflammatory, the degree of improvement of the overall skin pattern in terms of dilated facial pores, scar improvement, skin texture, and tone were evaluated. We assessed the system’s safety and efficacy by employing objective parameters. In summary, we recommend using the pulsed wave mode of fractional RF microneedling as a safe and efficacious nonpharmacologic treatment modality for IAV.

5. Conclusions

The pulsed wave mode of fractional radiofrequency microneedling is a treatment that is both secure and viable on inflammatory acne vulgaris with improvements in scarring, enlarged pores, and skin texture. Furthermore, this method does not exacerbate active acne lesions.