October 17, 2015
2 min read

Kybella found to be effective, satisfactory in men in analysis of phase 3 trials

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CHICAGO — Men treated with Kybella in two phase 3 trials had a reduction in submental fat and were satisfied with the treatment, according to study results presented at the American Society for Dermatologic Surgery annual meeting.

“The post-hoc analysis of the Refine-1 and Refine-2 trials showed that men got very good results, just like women did” researcher Vince Bertucci, MD, told Healio.com. “It was a safe and effective treatment; the most common adverse events consisted of bruising, swelling and pain ... and patients were satisfied with their appearance.”

Vince Bertucci

The research was based on two identical phase 3 trials of 1,022 patients with moderate to severe submental fat who were dissatisfied with their submental region. Patients received six treatments of either Kybella (deoxycholic acid, Allergan/Kythera) or placebo administered subcutaneously every 28 ± 5 days. A composite 1-grade response and 2-grade response based on investigator and patient assessment were co-primary endpoints measured 12 weeks after final treatment.

Researchers conducted a post-hoc analysis of 156 men (15.3% of the total patient population; 80 of whom were randomized to receive deoxycholic acid and 76, placebo) in the trials with a median age of 47 years and a mean BMI of 29.6.

Men receiving deoxycholic acid had a composite 1 grade response of 64.4% compared with 8.6% in the placebo-treatment cohort and 9.6% compared with 0% in the composite grade 2 response.

The majority of men in the deoxycholic-acid treated group using the Subject Self Rating Scale reported being satisfied with their appearance (79.2%) compared with 22.9% in the placebo-treated group (P < .001).

An adverse event was reported by 96.3% in the deoxycholic treated group and 78.9% in the placebo group, with most being mild to moderate and confined to the treatment area.

“If you look at the number of men that were enrolled in the trial as a percentage of total participants, it was higher than what you see in aesthetic clinical practices,” Bertucci said.

According to surveys conducted by the American Society of Aesthetic Plastic Surgery, of those receiving facial aesthetic injectable treatments in 2014, only 10.4% were men, while 15.3% of the study’s population were men.

“I wonder if this might mean that this is an area that men are more interested in treating than other areas. So ... perhaps we'll see a higher uptake of men seeking out submental fat reduction. In my opinion, men are very interested in addressing two concerns: hair loss and submental fat or double chin.” – by Bruce Thiel

Disclosure: Bertucci reports having served as an investigator, speaker and consultant for Kythera Biopharmaceuticals and Allergan.