Revance Therapeutics announced the FDA will initiate its pre-approval inspection of the company’s daxibotulinumtoxinA (DAXI, Revance Therapeutics) manufacturing facility by the end of June 2021.

The company reports that in November 2020, the FDA advised Revance that it was deferring a decision on the Biologics License Application (BLA) for DAXI because the pre-approval manufacturing facility inspection could not be conducted due to COVID-19 pandemic-related travel restrictions.

Revance is seeking approval of DAXI for injection for the treatment of moderate to severe glabellar lines (GL).

1. Revance provides update on daxibotulinumtoxina for injection pre-approval inspection. BioSpace. Accessed June 4, 2021. https://www.biospace.com/article/revance-provides-update-on-daxibotulinumtoxina-for-injection-pre-approval-inspection/

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Revance provides an update on the approval process for its injectable daxibotulinumtoxinA (DAXI) for the treatment of glabellar lines.

FDA to Initiate Pre-Approval Inspection of DAXI Manufacturing Facility

Trichoscopy, a method of hair and scalp evaluation based on dermoscopy, is an essential tool in the dermatologist armamentarium for diagnosis of causes of hair loss, rare genetic hair shaft abnormalities, and inflammatory scalp diseases.

In a presentation at the American Academy of Dermatology Virtual Meeting Experience 2021 in April, Lidia Rudnicka, MD, PhD; Anna Waśkiel-Burnat, MD, PhD; Sergio Vañó-Galván, MD, PhD; and Bianca Marie Piraccini, MD, discussed best-practice recommendations for using trichoscopy as an aid in hair and scalp diagnosis and treatment.

Rudnicka, a professor and chairman of the department of dermatology at Warsaw Medical University in Poland, discussed the 7 distinct ways to spot trichotillomania in patients with hair loss.

Trichotillomania, a mental disorder classified under the obsessive-compulsive umbrella, involves “the recurrent and irresistible urge to pull hair from the scalp, eyebrows, eyelashes, and other body areas,” she said.

Rudnicka listed tips for diagnosing the disorder:

1. Look for evidence of hook hairs, categorized by hairs with a distal end shaped like a hook, due to its high link to the mental disorder. “If we see a field of view with multiple hook hairs, we can be almost sure this is trichotillomania because the hook hairs have a 100% positive predictive score,” she said.

2. Check for the presence of coiled hairs, seen to be irregular in shape with a jagged end. This is not to be confused with circle/pigtail hairs seen in alopecia areata, which are regular in shape with a sharp distal end.

3. Watch for V-sign hairs from a patient pulling 2 or more hairs from 1 follicle unit. An indication of the disorder, they are formed from creating breakage in similar areas of the strands.

4. Monitor the patient for trichoptilosis, which are young short hairs with split ends.

5. Examine patients for flame hairs, which is hair residue that is semitransparent, wavy, and thinning toward the distal end.

6. Watch for hair powder, which is even more dispersed participles of hair residue.

7. Identify any sign of tulip hair, which develops when a hair is broken diagonally and gives the impression of distal hyperpigmentation in the shape of a tulip head.

Rudnicka also highlighted the lesser-known trichotillomania incognito.

“This is a case of a person who has almost normal-looking hair but complains of a tendency of hair that has stopped growing,” she said. “[With] trichoscopy, you will see very discreet features of trichotillomania.”

Waśkiel-Burnat, a clinician at the department of dermatology at the Medical University of Warsaw, discussed the differentiating features of inflammatory scalp diseases using trichoscopy.

Using 4 cases of scalp diseases that presented with similar symptoms, she highlighted key ways to distinguish the diseases.

In her first example, Waśkiel-Burnat diagnosed mycosis fungoides through the presence of pili torti (hair with a twisted hair shaft), 8-shaped hair (resembling a number 8), white scaling, and perifollicular arrangement of linear and glomerular vessels.

In another case, seborrheic dermatitis presented with symptoms consisting of yellow and whitish scaling and arborizing vessels, which are commonly observed in these patients, she said.

A third example of psoriasis showed signs of white scaling, glomerular vessels, and punctate hemorrhages. And lastly, a patient with dermatomyositis showed evidence of enlarged tortuous capillaries, bushy capillaries, and interfollicular and perifollicular scaling.

Highlighting the main trichoscopic features of lichen planopilaris (LPP), Vañó-Galván, head of the trichology unit at Ramón y Cajal Hospital in Madrid, Spain, discussed the difference between active lesions and inactive lesions. He included other features such as pili torti, blue gray dots in a target pattern, and broken hairs.

Active lesions can be distinguished by perifollicular scaling and peripilar casts. According to Vañó-Galván, these scales migrate along the hair shaft and form a tubular structure that covers the proximal portion of the emerging hair shaft. This is believed to occur due to changes in the outer hair follicle root sheath, he said.

Elongated linear blood vessels are another indicator of active LPP lesions. These vessels form a V with the corresponding emerging hair shaft. Violaceous follicular erythema is additional evidence of this, according to Vañó-Galván.

Inactive lesions on the other hand have irregular, large white dots, white or milky red areas, and tufted hairs.

Piraccini, an associate professor in the department of specialized experimental and diagnostic medicine in the Alma Mater Studiorum at the University of Bologna, Italy, uses trichoscopy not only as a diagnostic tool but also to grade severity, diagnose associated diseases, and monitor treatment outcomes for androgenetic alopecia.

She uses the tool in mostly the anterior/vertex/temples where there are androgen-sensitive hair follicles and the occipital area where hair follicles are not as sensitive to androgens.

Androgenetic alopecia trichoscopy signs include reduced hair thickness with an increased number of hairs with the diameter of less than 3 mm, empty follicles, reduced number of hairs per pilosebaceous unit, and peripilar halos, according to Piraccini. Thinning is especially evident in the frontal area because of hair follicle miniaturization, she said.

She monitors treatment outcomes through trichoscopy as a clear and easy way for patients to understand the indicators of increased hair density and health.

“I follow the patient every 6 months, and after the first 6 months trichoscopy shows improvement,” Piraccini said. “I show the patient the positive outcomes in the number of hairs and the thickness.”

Trichoscopy, as presented by the 4 experts, plays an essential role for diagnosing hair or scalp disease, and showcases the ease of treatment monitorization.

Rudnicka and Waśkiel-Burnat reported no relevant financial disclosures. Vañó-Galván is a speaker and adviser for Almirall, Cantabria Labs, Laboratoires Pierre Fabre-Ducray, and L’Oréal. He is a speaker for Novartis International AG, GlaxoSmithKline, Merck & Co, and Galderma; he is an adviser for Pfizer Inc, Janssen Pharmaceuticals, and Isdin. He has received research funding from Novartis International AG, Cantabria Labs, Fagron, and DS Pharma. Piraccini disclosed industry relationships with Laboratoires Pierre Fabre-Ducray, Legacy Healthcare, Pfizer Inc, Almirall, Difa Cooper, and Dercos L’Oréal.

1. Rudnicka L, Waśkiel-Burnat A, Vañó-Galván S, Piraccini B. Trichoscopy: an update. American Academy of Dermatology Virtual Meeting Experience 2021; April 23-25, 2021; virtual. Accessed May 7, 2021.

2. Rudnicka L. Trichoscopy of trichotillomania. American Academy of Dermatology Virtual Meeting Experience 2021; April 23-25, 2021; virtual. Accessed May 7, 2021.

3. Waśkiel-Burnat A. Trichoscopy cases of inflammatory scalp diseases. American Academy of Dermatology Virtual Meeting Experience 202; April 23-25, 2021; virtual. Accessed May 7, 2021.

4. Vañó-Galván S. Trichoscopy of lichen planopilaris. American Academy of Dermatology Virtual Meeting Experience 2021; April 23-25, 2021; virtual. Accessed May 7, 2021.

5. Piraccini B. Trichoscopy of androgenetic alopecia. American Academy of Dermatology Virtual Meeting Experience 2021; April 23-25, 2021; virtual. Accessed May 7, 2021.

Trichoscopy, which is based on dermoscopy, can be a valuable tool for diagnosing conditions that cause hair loss and inflammatory scalp disease.

Trichoscopy Advances Hair and Scalp Disease Diagnoses

 details the annoying truth of adult acne, 

 takes a look inside Hydrafacial’s summer tour, 

 talks the realities of “natural” skin care, and 

 highlights chest acne treatments and skin pores. 

Adult Acne: Why You’re Still Breaking Out in Your 20s and 30s

Treat Boob Acne in 4 Easy, Expert-Backed Steps

Every Question You’ve Ever Had About Pores, Answered

What Dermatologists Want You to Know About "Natural" Skin Care

This week, consumer magazines highlight the realities of “natural” skin care, adult acne, and more.  

“Natural” Skin Care: What Patients Should Know  

This week in aesthetics, Paul Nassif, MD, discusses how to build a skin care brand, the NPD Group reported the changing 2020 skin care trends due to the COVID-19 pandemic, experts highlight the trend of minimally invasive procedures using MyEllevate, and Gary Linkov, MD, provides an overview of beard and eyebrow grafting that is gaining popularity.

Paul Nassif, MD: Building a Successful Skin Care Brand 

Creating a skin care line involves dedication, product testing, clinical trials, marketing, sales, and yes, a lot of money.

Women’s use of facial skin care products saw a significant rise in 2020 due to the COVID-19 pandemic, according to The NPD Group, a market research company.

MyEllevate Reinforces Trend of Minimally Invasive Procedures 

Expert physicians highlight the rise in minimally invasive procedures using the MyEllevate light guided suture technology for neck and facial rejuvenation.

The Growing Rate of Facial Hair Transplants

Facial hair grafting is becoming an increasingly popular procedure with methods such as follicular unit extraction (FUE) and follicular unit transplantation (FUT) to improve the hair appearance of beards and eyebrows.

This week in aesthetics, we highlight how to create a skin care line, 2020 skin care trends, MyEllevate neck and facial rejuvenation, and the increasing popularity of facial hair transplants.  

This Week in Aesthetics: June 7 – June 11

While scalp hair transplants are common in aesthetics, using hair transplant technology to improve facial hair outcomes is gaining increased popularity for patients who wish to improve beard and eyebrow fullness. In an interview with 

, Gary Linkov, MD, board-certified facial plastic and hair surgeon and founder and medical director of 

 in New York, New York, gives an overview of beard and eyebrow grafting to improve patient facial hair appearance.


First, when patients are preparing for grafting, he says, they are directed to stop all oral supplements along with over-the-counter medications that can cause blood thinning.


“Vitamin C and Vitamin K a week before the facial hair transplant procedure can help improve healing and minimize bleeding,” he says.


Patients shower the night before or the morning of the procedure to prevent infection and are also prescribed an antibiotic, an anti-inflammatory pill, a sedative, and ananxiolytic the morning of the procedure, he explains. Following patient consent, the beard area or eyebrow area is marked carefully to incorporate the patient’s wishes.


Patients then undergo follicular unit extraction (FUE), which takes hair strands with the follicles attached from one body site and then transplants them to the desired area. Another method of transplanting hair is follicular unit transplantation (FUT), which excises a strip of skin with hair follicles to be used.


“Once the grafts are removed, recipient site creation and then placement of the grafts occurs,” Linkov says. “The overall process may take a few hours for smaller cases, up to a full day for larger cases, and occasionally may require an extra day. A lunch break is provided for longer cases.”


Explaining the procedure downtime, he says bleeding, swelling, and bruising are all possible after a facial hair transplant. “The most important precaution in the recovery phase of a beard transplant is to not get the transplanted hairs wet for the first 5 days. This allows them to set in the proper orientation and to eventually grow,” he emphasizes.


Post-procedure, patients are also given both an oral and topical antibiotic for the donor area, he says.


For beard transplants, patients are able to shave after 10 days, he says. Linkov explains that after about 3 weeks the shafts of the transplanted hairs will usually fall out. Hair regrowth then starts at 4-6 months, with patients having final results assessed at 1 year.


There are some associated risks with the procedure; one of which is poor angulation. 

“Despite every best effort to use an acute angle to the skin surface when making recipient sites and placing grafts, occasionally, grafts may still grow at a more perpendicular angle and may need to be removed,” he notes.


There is also the chance of bump formation. “The main area at risk of small bump formation is the goatee area under the lower lip,” Linkov says. “These can be difficult to correct.”


The risk of poor regrowth, while possible, is rare, according to Linkov. “The face has very good blood supply and typically results in excellent hair regrowth,” he says. “A touch-up procedure is sometimes needed after 10 months if certain areas show poor growth.”


Finally, inclusion cysts can occur but are very rare in the transplanted beard area and may need to be incised and drained or removed, he says.


Linkov explains that scar formation is another consideration. Small circular scars are left after using the FUE method, “but they are barely noticeable even with a shaved head,” he said. The FUT method, however, leaves a linear scar across the back of the head, which makes it more difficult to wear shorter hairstyles.


“The recipient area where the new beard hairs grow should not display any scars,” he explains.


Medical conditions not compatible with local anesthesia containing epinephrine would be contraindications to FUE and FUT facial hair transplantation.


“Contraindications to facial hair transplants is scarring alopecia’s or autoimmune alopecia areata, in which the body will continue to try and destroy the hair follicles,” he says, adding that having minimal hair supply for transplantation to the facial area is also a contraindication.


1.	NYC Beard Transplant/New York Beard Restoration/UES. City Facial Plastics. 2021. Accessed May 25, 2021. https://cityfacialplastics.com/beard-transplant/


2.	NYC Eyebrow Restoration/New York Eyebrow Hair Transplant/UES. City Facial Plastics. 2021. Accessed May 25, 2021. https://cityfacialplastics.com/eyebrow-transplant/

Facial hair grafting is becoming an increasingly popular procedure with methods such as follicular unit extraction (FUE) and follicular unit transplantation (FUT) to improve the hair appearance of beards and eyebrows. 


Now that the days of safe in-person services are returning, and thanks to consumers with pent-up buying impetus and a year’s worth of savings, the dermatology and cosmetic surgery sectors are experiencing a notable trend: The popularity of minimal to noninvasive cosmetic procedures is surging. Chief among those procedures is the patented MyEllevate light-guided suture technology for facial rejuvenation. As clients experience these innovative techniques and their significant results with negligible recovery time, they are referring their friends and coming back for more. MyEllevate has become the poster child for minimally invasive procedures. Cynosure’s recent acquisition of MyEllevate confirms the method’s arrival as the leader of this new and improved generation of technology.

The question most people ask is what is MyEllevate, and how did this paradigm shift occur in a steadfast industry like cosmetic surgery?

Gregory Mueller, MD, FACS, a plastic surgeon in Beverly Hills, California, developed MyEllevate and the ICLED light-guided suture system. The highly effective neck rejuvenation technique has minimal downtime and long-lasting results. In addition to its speedy recovery time, MyEllevate effectively treats a broad range of aging-related concerns: from excess neck fat to bulging glands and prominent platysma bands.

MyEllevate was designed very simply as a percutaneous approach to placing a neck suspension suture. Vincent C. Giampapa, MD, FACS, and Barry DiBernardo, MD, published an article in 2000 on placing a neck suspension suture during an open facelift.

 Mueller took this concept and over a 15-year period developed the MyEllevate procedure. Initial variations had issues with the depth of suture placement, which led to the light-guided approach of the procedure. He experimented with many types of absorbable and permanent sutures, finally deciding on a 4-0 braided permanent suture.

The surgeon performs the procedure in an operating or procedure room under local anesthesia or intravenous sedation of general anesthesia, according to the patient’s wishes. The approach is simplified and broken down into easy-to-learn steps.

The patient is prepped and the platysma bands, if present, are marked and injected with local anesthetic. A puncture wound is made adjacent to the bands with a specialized puncture tool and then the attachments are cleared with a “clearing” tool that is part of the ICLED kit. The rod and Suturod suture, also included in the kit, are placed deep and superficial to the band. The band is then cut by sawing the suture back and forth until the suture pulls through.

The neck is tumesced with 300 to 400 cc of standard tumescent solution. If desired, the physician can use an energy-based device internally; however, this step may be omitted.Commonly used devices include Precision Tx SmartLipo (Cynosure),

 or the Vaser ultrasonic system (Solta Medical).

 Liposuction is then performed and damaged fat is removed, and the area is additionally undermined by the liposuction cannula.

). The light is activated and placed on the rod, then the light-guided suture is placed through standardized puncture sites. The suture is tied through the first puncture site and cut. The rod is then used to help bury the knot. Finally, a dressing is applied.

The procedure is routinely performed in under 1 hour and patient recovery is swift. Patients are asked to wear a soft collar for 10 days after surgery and many resume normal activities within 48 hours.

The MyEllevate team vets all physicians before they are trained in the procedure to help maintain quality control. Physicians are asked to go to the Myellevate.com website to register and then watch a recorded procedure. Live training is available at 4 US sites and a trainer is sent to observe the physician’s first 2 cases.

The procedure has been rapidly implemented by physicians and has generated much interest from patients in recent times. An article in 

magazine brought national exposure to MyEllevate in its December 2020/January 2021 print issue, dubbing the procedure the “Zoom Lift.”8

The procedure’s popularity started with the struggle shared by many people during the early days of Covid-19, which in turn abruptly introduced the work-from-home culture. Dermatologists and plastic surgeons were suddenly inundated with requests and complaints about previously unobserved “trouble areas,” and their appointment books began to fill quickly. On a global scale, working professionals went from looking at their faces for perhaps 30 minutes each day—from a glimpse in the mirror to a quick FaceTime call and the occasional selfie—to staring at them for 8-plus hours daily on Zoom as they worked remotely. This increased, targeted focus on facial features led to many plastic surgeons’ clients scrutinizing their imperfections on an intensified level that substantially raised the demand for cosmetic procedures, including MyEllevate.

Mueller is the creator of MyEllevate. Pozner and DiBernardo stockholders in ICLED Surgical and trainers for MyEllevate.

1. Cynosure to acquire MyEllevate, innovative minimally invasive facial rejuvenation treatment. Cynosure, Inc. Press release. April 30, 2021. Accessed June 8, 2021. 

https://www.prnewswire.com/news-releases/cynosure-to-acquire-myellevate-innovative-minimally-invasive-facial-rejuvenation-treatment-301281186.html

2. MyEllevate. MyEllevate. Accessed June 8, 2021. 

3. Giampapa VC. Suture suspension technique offers predictable, long-lasting neck rejuvenation. 

. 2000;20(3):253-255. doi:10.1016/S1090-820X(00)70026-4

4. Precision Tx. Cynosure. Accessed June 8, 2021. 

https://www.cynosure.com/product/precisiontx/

5. FaceTite: minimally invasive face contouring. InMode. Accessed June 8, 2021. 

https://inmodemd.com/technologies/technologies-facetite/

6. Renuvion. Apyx Medical. Accessed June 8, 2021. 

7. Vaser ultrasonic system. Solta Medical. Accessed June 8, 2021. 

Expert physicians highlight the rise in minimally invasive procedures using the MyEllevate light-guided suture technology for neck and facial rejuvenation.