This week in aesthetics, a new survey quantifies the QoL data for transmen post gender-affirming surgery, a study examines abdominal contouring using HIFEM and RF combination therapy, Allergan Aesthetics announces the acquisition of Soliton, a comparative study looks at laser comparisons in keloid management, a study details cetirizine 1% cream for androgenetic alopecia, and Ava Shamban, MD, discusses microneedling differentiators using the Vivace Microneedle RF device.

Psychosocial Benefits of Gender Affirming Surgery

A new survey from the University of California is the first to quantify the quality-of-life data for transgender men who undergo gender-affirming surgery.

Abdominal Contouring Using HIFEM and RF Combination Therapy

A recent study looks at the safety and efficacy of HIFEM and RF combination therapy for fat reduction.

Allergan Acquires Soliton Following Launch of RAP Device

Allergan Aesthetics, an AbbVie company, announces the acquisition of Soliton and its newly launched RAP device, further expanding the company’s body contouring portfolio.

A comparative study examines Fractional CO2 and Nd‐YAG laser effectiveness in keloid management.

Cetirizine 1% Cream for Androgenetic Alopecia

A recent study examined cetirizine 1% cream as treatment in male patients diagnosed with androgenetic alopecia.

Ava Shamban, MD, discusses microneedling differentiators using the Vivace Microneedle RF device, combination therapies, and the importance of social media partnerships.

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This week in aesthetics, we highlight a new survey quantifying the QoL data for transmen post gender-affirming surgery, abdominal contouring using HIFEM and RF combination therapy, and more.

This Week in Aesthetics: May 10-14

Ava Shamban, MD, founder and director of AVA MD and SKINxFIVE, Santa Monica, California, recently spoke with 

Perspectives: The Evolution of Aesthetics

Highlighting microneedling differentiators, she discussed Aesthetics Biomedical's 

The Vivace device delivers RF energy to the lower dermis of the skin through microneedling, creating precise microdamage that jumpstarts the body’s cell-regeneration process, according to the company’s website. The treatment remodels and stimulates production of collagen and elastin, according to Aesthetics Biomedical, which over time results in firmer, plumper, and smoother skin. She also discussed her strategies for using microneedling devices as monotherapy and in combination therapy.

Shamban’s presentation on combination therapies detailed the use of 

 for minimally invasive skin rejuvenation around the eyes and mouth, in addition to other treatments for optimal results.

 about the importance of social media partnerships, including the new up-and-comer, TikTok, for connecting with not only potential patients, but the general public, and fellow medical professionals.

Videos

Microneedling Differentiators

, investigated the tolerability and efficacy of topical cetirizine 1% in male patients diagnosed with androgenetic alopecia (AGA), the most common form of alopecia in males.

 Male AGA (MAGA) is an androgen-dependent condition unlike female (FMAGA) where the androgen role is not fully understood.

Cetirizine is a second-generation histamine (H)1 blocker that is known for its anti-inflammatory properties and its ability to decrease prostaglandin D2 (PGD2) production. Currently, only one report has shown that topical use of cetirizine at 1% strength induced hair grow in mild to moderate cases of AGA and decreased the densities of vellus hair.

The study enrolled 60 male patients between the ages of 22 and 55 years with different severities of AGA. The severity was based on the Hamilton‐Norwood classification and the patients were randomly assigned into 2 cohorts. Patients in group A applied 1 mL of 1% topical cetirizine daily for 6 months. Group B patients applied 1 mL of a placebo solution as a control. Patients were given identical non-labeled bottles with a code that both the doctor and patient were blinded to. 

Patients that were diagnosed with systemic diseases, suffering from chronic scalp conditions, using any medications that can potentially induce hair loss within 3 months before the study were all excluded. 

Data was reported in the number of regrowing hairs per cm

. A photographic assessment was used and put on a 4-grade scale (no improvement, mild improvement, moderate improvement, and good improvement). Also, a subjective assessment for the amount of improvement in hair quality on a number scale. This was defined as (-1, worse; 0, no change; 1, mild improvement; 2, moderate improvement; 3, good improvement; and 4, excellent improvement). Any adverse events (AEs) were recorded.

In group A, 17 patients (56.7%) demonstrated no new hair growth per dermoscopy, 6 patients (20%) showed 1 new hair growing per dermoscopic field, 5 patients (16.7%) had 2 growing hairs per field, and 2 (6.7%) showed 3 growing hairs per field. None of group B achieved growing hair per dermoscopic evaluation.

Similar results were shown in the self-assessment. In the control cohort, more than 86% reported no improvement and about 13% reported worsening of their condition. Compared to the treatment group, about 56% reported no improvement, 23.3% reported mild improvement, 16.7% reported moderate improvement and 3.3% reported good improvement.

Although this study shows cetirizine 1% as a potential treatment for AGA, study investigators note that more trials are needed to confirm or refute such early findings. 

1. Zaky MS, Khodeir HA, Ahmed H-A, Elsaie ML. Therapeutic implications of topical cetirizine 1% in treatment of male androgenetic alopecia: A case-controlled study. Journal of Cosmetic Dermatology. 2021;20(4):1154-1159. doi:https://doi.org/10.1111/jocd.13940

 laser and a Nd‐YAG laser as use in keloid management.

 It is currently the only study to compare the 2. 

, Nd-YAG, and a combination of both for keloid management. 45 patients who were diagnosed with keloids enrolled into the 3 groups equally. Each of the groups received their designated treatment every 4 weeks for 4 sessions, breaking down to 1 session a month for 4 months. Improvement of keloids was evaluated by the Patient and Observer Scar Assessment Scale (POSAS) and detection of procollagen I messenger ribonucleic acid (mRNA) by reverse transcription polymerase chain reaction (RT‐PCR) analysis was done to confirm observation. 

Once data was received, the assessment by POSAS demonstrated that the most significant clinical improvement was in the combination group. Less significant improvement was found in the fractional CO

 group and the least improvement was seen in the Nd-YAG group. Additionally, the results matched when the molecular analysis was done by RT-PCR. 

In the end, the study findings show that the combination of fraction CO

 and Nd-YAG laser were the most effective in the management of keloids. This was due to the synergistic effect the combination achieved. It was also found that the fractional CO

 laser was more effective than the Nd-YAG in stand alone treatment. 

Further analysis is needed to determine the long-term safety data for the combination treatment. 

1. Soliman M, Etman Y, AbdElhameed A, Elsharaby R, Tawfik A. Comparative study between nd-yag laser, fractional co2 laser, and combined nd-yag with fractional co2 laser in the management of keloid: clinical and molecular study. Journal of Cosmetic Dermatology. 2021;20(4):1124-1132. doi:https://doi.org/10.1111/jocd.13920

Laser Comparison in Keloid Management

On the cusp of Soliton’s announcement launching RESONIC1, a Rapid Acoustic Pulse (RAP) device, Allergan Aesthetics, an AbbVie company, announced its plan to expand its body contouring portfolio by acquiring Soliton and RESONIC for $550 million.

“This is an exciting day for Soliton and the RESONIC brand,” said Brad Hauser, president and CEO, Soliton. “It’s been a long time in the making and we’re excited to finally bring this innovative and efficacious solution to procedures that have had historically low patient satisfaction or required numerous treatment sessions to achieve expected results.”

Carrie Strom, president of Global Allergan Aesthetics and senior vice president of AbbVie, added, "Soliton's technology offers a new, completely noninvasive approach with clinically proven results to reduce the appearance of cellulite with no patient downtime. The addition of this technology complements Allergan Aesthetics’ portfolio of body contouring treatments. Health care providers will now have another option to address consumers' aesthetic concerns."

This year, the FDA gave RESONIC 501k clearance as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in patients with Fitzpatrick skin types I-III in 2020

 and for short-term improvement in the appearance of cellulite in the buttocks and thighs.

The RAP device utilizes a rapid pulse of acoustics to break apart the fibrous septa band underneath the skin that causes cellulite, as well as removal tattoos. The device is also currently being investigated for treatment of fibrotic scars.

“RESONIC revolutionizes the industry’s approach to two notoriously challenging patient needs. The technology’s ability to physically change targeted cellular structures without breaking the skin is game changing,” said Elizabeth Tanzi, MD, member of Soliton’s Scientific Advisory Board. “Clinical trial results for both RESONIC procedures showed significant results with accelerated treatment timelines, which I believe will result in higher patient satisfaction and will minimize common barriers to entry that exist for tattoo removal and cellulite reduction.”

According to the Soliton, it plans on making the device available to physicians and medspas in June 2021.

Introducing RESONIC™. BioSpace. May 5, 2021. Accessed May 11, 2021. 

https://www.biospace.com/article/introducing-resonic-/

Allergan aesthetics to acquire soliton, expanding body contouring portfolio | AbbVie news center. May 10, 2021. Accessed May 11, 2021. 

https://news.abbvie.com/news/press-releases/allergan-aesthetics-to-acquire-soliton-expanding-body-contouring-portfolio.htm?view_id=5591

Petronelli M. Soliton’s Generation II tattoo-removal device receives 510(k) premarket notification. Dermatology Times. Published online March 11, 2020. Accessed May 11, 2021. https://www.dermatologytimes.com/view/solitons-tattoo-removal-device-receives-510k-premarket-notification

Petronelli M. FDA Clears Soliton’s RAP Device for Cellulite. Dermatology Times. Published online February 2, 2021. Accessed May 11, 2021. https://www.dermatologytimes.com/view/fda-clears-soliton-s-rap-device-for-cellulite

 recently investigated the structural changes in the subcutaneous tissued brought on by the mixture of radiofrequency (RF) treatment and high intensity focused electromagnetic technology (HIFEM).

Noninvasive fat tissue reduction is energy dependent and can be achieved in 2 ways: reducing the fat stores or permanently removing adipocytes. These different methods of thermal—RF—and nonthermal—HIFEM—body contouring technologies allow for its combined use. 

The prospective single center study’s criteria included a BMI greater of 35.0 kg/m2, with none of the following: pregnancy or breast feeding, injury in the treated area, active participation in any other concurrent therapy, and general contraindications for HIFEM and RF application to the patient.

In total, 5 patients were enrolled, 4 were assigned for active treatments and had a mean of 51.50 ± 6.35 years and a mean BMI of 22.59 ± 3.21 kg/m2. The fifth patient was a control, with an age of 57 years and BMI of 23.60 kg/m2. 

Each participant received three 30-minuted abdominal treatments once per week with a device that simultaneously delivered synchronized RF and HIFEM energies (Emsulpt NEO; BTL Industries Inc). 

“Based on the patient's physical constitution, [1 or 2] applicators were placed over the treated area and affixed by an elastic fixation belt,” wrote study investigators.

The output power of RF was set to 100% in the active treatments and 5% for sham treatments. The intensity of HIFEM (0%‐100%) in the active group was adjusted according to patient feedback, ending with a maximum tolerable level for the patient. HIFEM intensity in sham treatments was again set to 5%.

Punch biopsies of adipose tissue were obtained from each patient at baseline, 1 week post treatment, and at the 1-month follow up. Each sample was 4 mm in diameter and 3 samples were collected from each subject, totaling 15 samples. These samples were analyzed by a histopathologist via light microscope (Leica DM1000; Leica Microsystems) and evaluated for the structural changes of fat tissue. 

The secondary outcome for the study included documentation of the treatment area by digital photographs, waist circumference, weight measurements, 5‐point Likert scale satisfaction questionnaire, and 10‐point visual analog scale (VAS) therapy comfort questionnaire assessed at baseline, 1 week post procedure, and 1 month follow‐up. 

There were no adverse events (AEs) reported during the study and all patients finished treatment. Transient muscle soreness, typically occurring the day after therapy, and erythema that resolved within a few hours were the only document side effects. On a scale of 0 to 10, 0 being no discomfort and 10 being unbearable discomfort, the average score was 0.83. 

Histological examination of baseline and control samples revealed healthy round and polygonal shaped unilocular cells. In comparison, the treated samples taken at Week 1 showed visible alternations of the fat cell shape and occasional fat ruptures. 

“The evidence of ongoing programmed cell death processed was documented by the presence of pyknotic nuclei manifested by hypercondensation of chromatin and destructive fragmentation of the nucleus,” according to the study investigators.

These findings persisted up to Month 1 and no such changes were found after the administration of sham treatment. 

At baseline, both groups showed similar values in adipocyte size, however, post treatment samples showed a significant reduction in size. At Week 1, there was a 33.5% reduction for the treatment group which was sustained at 31.7% during the 1 month follow up. 

Additionally, the effective temperature needed to induce structural changes in adipose tissue—43‐45°C—was held during the majority of the treatment time.

Weight fluctuations in the active group were insignificant with −0.2 kg at 1 week and −0.3 kg at 1 month. There was a visible improvement of the abdominal body contour. The average waist circumference reduction in the active cohort was -2.20 cm to -5.4 cm. The control subject did not show improvement. Patients who received therapy with the maximum intensities agreed (4) or strongly agreed (5) with the statement that the appearance of their abdominal area had improved.

The results suggest the efficacy and safety of RF and HIFEM combination therapy. Future research is needed to look at programmed cell death markers for adipocytes and also determine the duration of induced changes in a broader patient sample.

“The results indicate that the simultaneous treatment triggers lipolysis along with fat cell elimination,” study investigators wrote. “The reduced adipocyte size is strong evidence for lipolysis as the adipocytes lose their intracellular content due to the breakdown of triglycerides into glycerol and FFA, which are subsequently liberated into the blood stream.”

1. Goldberg DJ. Deletion of adipocytes induced by a novel device simultaneously delivering Synchronized radiofrequency and HIFEM: Human histological study. Journal of Cosmetic Dermatology. 2021;20(4):1104-1109. doi:https://doi.org/10.1111/jocd.13970

A recent study looks at the safety and efficacy of HIFEM and RF combination therapy for fat reduction. 