Aesthetic treatments to combat components of the skins natural ageing process have become more varied with a large variety of options available to patients who seek to improve their natural skin condition. Skin aging can often be characterized by wrinkles, overall texture, vascular conditions, and unwanted pigmentation. Skin ageing occurs naturally as part of the overall ageing process but is often accelerated in patients due to everyday activities which result in additional exposure to ultraviolet rays from the sun which is the primary cause of visible facial aging signs [1]. The effects of skin aging is heavily linked to the amount of collagen and elastin in the tissue and it can be concluded that finding a treatment to combat the effects of skin aging needs to involve the stimulation and production of these two components in the skin [2].

Radiofrequency microneedling (RFMN) has been a heavily explored modality for the treatment of multiple skin conditions included overall rejuvenation and skin laxity. RFMN delivers fractional energy through a large array of microneedles that penetrate the skin into the deeper layers of the dermis that typical laser treatments alone would not be able to reach. The needles deliver the radiofrequency energy to heat up the deep tissue safely while also resulting in overall skin tightening and a rejuvenated appearance [3,4]. RFMN has shown excellent efficacy in rejuvenation, skin laxity and rhytides in multiple studies [5-7].

In stark contrast to the invasive treatment completed by RFMN, nonablative 1,927-nm fractional thulium fiber lasers (TFLs) have been heavily explored for their efficacy in overall skin rejuvenation, pigmentary disorders, and even some of the same photoaging effects of RFMN such as wrinkling, skin laxity, and texture [8,9]. TFL treatments focus on the more superficial layers of the skin allowing it to target pigmentation while also treating additional conditions with collagen neogenesis [10].

The combination of these two treatment modalities to target both the superficial and deep layers of the skin results in an efficacious treatment with significant clinical benefit for patients. Despite both devices primarily targeting water, multiple studies have also shown that the combination treatment with both devices even during the same treatment session is safe for patients [5,11].

Study design

A total of 22 subjects were enrolled in the study. The average age of subjects in the study was 49.8 ± 12.4. All subjects in the study were female and presented with a range of conditions including skin laxity, wrinkles, and acne scars. Patients in the study were initially treated with a RFMN device (Genius; Lutronic) and then were treated immediately after with a TFL (LaseMD Ultra; Lutronic). Each of these treatment sessions was considered a treatment cycle. Subjects received up to five total treatment cycles with the average subject undergoing a total of three treatment cycles. Treatment cycles were conducted two months apart to allow for adequate skin healing prior to the next treatment. Subjects returned for a final follow-up with the physician between one and three months post treatment to confirm no additional treatments were needed and to have final photographs taken for assessments. Assessments were performed following completion of treatment and follow-up visits for all subjects. The schedule for patients who were reviewed in this case series is outlined in Fig. 1.

Figure 1. Subject timeline for treatment visits and follow-up. RFMN, radiofrequency microneedling; TFL, thulium fiber laser.

Device treatment

Prior to treatment with the RFMN, patients had numbing cream applied to their intended treatment area which was allowed to sit for approximately two and a half hours to ensure maximum comfort for the patient during the treatment. The device was utilized with a 49-microneedle treatment tip, a treatment depth typically set between 1.5 and 2.5 mm, energy settings of 30 to 80, and a total treatment energy ranging from 966 to 2,542 J. Each treatment consisted of either two or treatment depths, with up to 4 passes with 50% overlap completed for the first two treatment depths, and only one pass for the most shallow depth. Air cooling was used throughout the treatment to compliment the numbing cream and further reducing treatment pain. Treatments were completed by treating at the deepest setting and then progressively treating at more shallow depths for the later passes. Treatments with the RFMN often focused on acne scars, overall jawline improvements, and wrinkles. Parameters for the RFMN treatments are outlined in Table 1.

Table 1 . Radiofrequency microneedling treatment settings

	Treatment depth 1	Treatment depth 2	Treatment depth 3
Depth	2.0-2.5 (2.5 ± 0.1)	1.8-2.0 (2.0 ± 0.0)	2.0-2.5 (2.5 ± 0.1)
Energy	36-80 (55.6 ± 10.6)	34-80 (54.6 ± 11.3)	36-80 (55.6 ± 10.6)
Passes	1-4 (2.1 ± 0.7)	1-4 (2.1 ± 0.6)	1-4 (2.1 ± 0.7)

Values are presented as minimum-maximum (mean ± standard deviation).

Immediately following treatment with the RFMN, patients were treated with the TFL. The laser power was set to 5-18 W with a total number of passes ranging from 4-24. The number of passes changed on a subject to subject based on the severity of the skin condition present in the patient. This ensured that enough energy was delivered to the skin to generate coagulation which results in the volumizing effect from the treatment. Following treatment patients were asked to utilize corticosteroids to help reduce superficial inflammation and thus reduce the risk of hyperpigmentation and antibiotics to reduce the risk of infection for approximately three days following treatment. Patients were also asked to utilize to protect their skin from the sun. This post treatment regimen ensures that the RFMN and TFL were able to take full effect in the treated area while minimizing the risk of adverse events.

Clinical assessments

Photographs were taken before and after their treatments, as well as up to one year following their final treatment cycle. Photographs were taken from multiple angles to ensure that improvement could be fully assessed by the subject and blinded evaluators at the end of the study. The treating physician rated the subject’s improvement compared to baseline on a scale of zero to four, with a four indicating complete clearance of the patient’s condition. Patients also rated out their overall satisfaction ranging from very dissatisfied to very satisfied. Images were also presented to two independent reviewers to assess if they were able to discern the pre-treatment images to the posttreatment images. Safety assessments were completed throughout the study to monitor side effects.

Physician evaluation

Physician grading indicated an average improvement score of 3.5 ± 0.5 out of 4. Physician noted the highest level of improvement in subjects who presented with sagging skin. While significant results were seen as early as after 3 treatments, all subjects were treated until complete resolution of their condition.

Subject satisfaction

All subjects reported they were satisfied with the results of their treatment, with 59.0% reporting they were satisfied and the remaining 40.9% reporting that they were very satisfied.

Blinded evaluations

Two independent blinded evaluators were asked to evaluate 49 randomized (pre- and posttreatment) images for the 22 subjects included in the study. Evaluators were able to identify the posttreatment image 88.8% of the time, with the full breakdown of individual grader responses in Table 2. Blinded evaluators also rated a majority of subjects that were correctly identified as much improved when graded on a 5-point scale (Table 3). Twenty of 22 subjects (90.9%) had at least one angle where both evaluators correctly identified the subject as improved.

Table 2 . Blinded evaluation results

	Grader 1	Grader 2	Overall
Total number evaluated	49	49	98
Total number correctly identified	42	45	87
Total percentage correctly identified	85.7	91.8	88.8

Table 3 . Blinded evaluation improvement score of correctly identified patients

	Grader 1 (n=42)	Grader 2 (n=45)	Overall (n=87)
Very much improved	6 (14.3)	16 (35.6)	22 (25.3)
Much improved	15 (35.7)	18 (40.0)	33 (37.9)
Improved	18 (42.9)	9 (20.0)	27 (31.0)
No change	3 (7.1)	2 (4.4)	5 (5.8)

Values are presented as number (%).

Safety assessment

Patients were called approximately 2 to 3 days following their RFMN and TFL cycle to assess the expected and standard side effects. Edema, erythema and pinpoint bleeding were seen in nearly all patients but resolved without intervention within two days. Due to the use of numbing cream there were patients who reported a breakout of acne and pimples. There were no instances of hyperpigmentation among the subjects reviewed for this study.

The use of RFMN immediately followed by 1927 TFL results in clinical significant results for a wide range of patients with minimal downtime. The physician and subject both were highly satisfied with the overall treatment results and the blinded evaluations reinforced the idea that significant clinical improvements were seen across all patients reviewed for the study. The combined use of the two devices allows for relatively long-lasting improvement in patient’s skin laxity and textured skin. The most significant improvements in skin laxity were noted in oval of the face as well as in the lower mandibular area (Figs. 2, 3). The long-lasting improvement noted in textured skin translates well to satisfactory clinical improvement in both acne scars and dilated pores.

Figure 2. Before (A) and after (B) photos of a 35-year-old patient who received two treatments with radiofrequency microneedling and one treatment with thulium fiber laser. Photos were taken 1 year following completion of treatment regimen.

Figure 3. Before (A) and after (B) photos of a 67-year-old patient who received three treatments with radiofrequency microneedling and two treatments with thulium fiber laser.

While the Genius RFMN provides a significant portion of the long-term clinical benefit, the use of LaseMD Ultra TFL as a complimentary procedure immediately following the treatment is a crucial portion of the overall patient experience. Initially patients may not see immediate results from the RFMN due to the deeper depths that are being treated by the radiofrequency energy. By leveraging the 1,927 nm wavelength and lower power we are able to affect the more shallow parts of the tissue to provide an immediate improvement that can be appreciated by both physician and patient. Additionally, the incorporation of TFL appears to reduce the overall downtime and side effect profile that is seen from a standalone RFMN treatment. When treating darker skin types with the RFMN there is a risk of causing hyperpigmentation or gridding, which can often be treated by the 1,927 nm TFL to resolution without issue. This treatment program can be utilized for patients of all phototypes which is not always possible with laser therapy. In certain patients pimples appeared following the RFMN treatment. While antibiotic cream could potentially be used to prevent the occurrence of these pimples, the benefit was not seen in the duration of this study. It also appeared that in cases where an antibiotic ointment was utilized following treatment that the patients skin recovered more slowly compared to patients who did not utilize an antibiotic ointment.

The pain management is crucial to the overall patient experience as RFMN is often found extremely painful by a majority of subjects and difficult to manage by the treating physician. It was found that the use of an occlusive anesthesia for two and a half hours makes the treatment more comfortable, particularly when the energies utilized in the study are high. Utilizing both occlusive anesthesia prior to treatment and then air cooling during the treatment, patients experience essentially no pain. Air cooling also provides an additional benefit of lowering the overall inflammation seen in the superficial dermis which we believe reduces the overall risk of hyperpigmentation in the patient.

One of the major concerns when completing this treatment cycle is the risk of hyperpigmentation. During the physicians time with the device it was found that there are two ways to minimize the risk of this event occurring in the treated patients. To begin, it was found that at these shallow depths in darker skin types resulted in more instances of hyperpigmentation, especially when treating between 1.8 and 1.5 mm. These depths are occasionally beneficial for patients who present with acne scars, but for patients who are only looking to see improvement in their overall skin laxity there was no additional benefit seen with this third treatment depth. We decided to forego the most shallow third treatment depth and instead leverage the more shallow treatment that comes from the 1,927 nm TFL treatment. Secondly during the course of treatments a new tip was released which had the same configuration of 49 microneedles in a 7 × 7 array, but this time spread over a 2 × 2 cm handpiece tip instead of a 1 × 1 cm handpiece tip. By switching away from the initial configuration of needles to the more spread version of the 49 microneedle tip we appeared to reduce the amount of hyperpigmentation seen in the patients.

The number of treatment cycles was very consistent in our study, ranging from 2 to 5 but with most subjects achieving optimal results with 3 cycles on average. We found in our study with the devices that the number of treatment cycles needed to obtain optimum results was often linked to the overall age of the patient. We found the number of decades that the patient has been alive being close to the same number of cycles (RFMN and TFL treatment session) needed to deliver great results. If we were treating a 20 year old we often found either 1 or 2 treatments would be enough for clinically significant results while a 40- or 50-year-old patients may require either 4 or 5 total cycles to achieve near clearance of their condition. In cases where acne scars are being treated it was often found that only a single cycle was needed to get a clinically significant result. Within each treatment cycle the amount of energy delivered by the devices as well as the overall number of passes varied on each subject. The severity of the presented indication as well as patient’s tolerability was taken into consideration to ensure that clinically relevant parameters were chosen for each patient. In general as the total energy was increased in the treatments, the patients received enhanced results but also experienced greater postedema resulting in a delicate balancing act with each patient.

Following the completion of the treatment cycle subject’s exhibited a strong clinical benefit. With 90.9% of subjects showing a clinically significant benefit as identified by the blinded evaluators. Additionally the 100% satisfaction rate reported by the subjects shows that both physician and patient can appreciate the results that are obtained through the clinical program. Considering the minimal pain and side effects experienced by the patients with the high clinical success rate, this treatment program for full facial rejuvenation.

To ensure that patients who had attained their optimal clinical benefit were able to maintain clinically significant results we often recommend patients to return for maintenance treatments following completion of their treatment cycles. For the RFMN this means coming in once a year, and for TFL this would mean coming in for 2 or 3 treatments a year. TFL is excellent at dealing with the pigmentation that is often caused by sun damage and ultraviolet radiation, and due to being a low downtime procedure with minimal side effects for patients it is an ideal laser device to ensure that patients are able to maintain their healthy skin appearance.

In conclusion, the sequential use of Genius RFMN and LaseMD Ultra TFL results in clinically significant results in patients of varying age and skin conditions. While RFMN does a significant portion of the tightening and lifting of the skin the TFL is able to accelerate the healing process and reduce side effects from the RFMN treatment while also addressing superficial skin conditions such as pigmentation by brightening patient skin tone and giving the patient an immediate posttreatment glow.

None.

I would like to thank my assistant, Mounia Boukhalfa.

All work was done by YMR.

No potential conflict of interest relevant to this article was reported.

None.

Contact the corresponding author for data availability.