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BELKYRA ®

is an or fat dissolving injection that has been available in the UK since 2021. It is a prescription only which contains deoxycholic acid and is used to treatment or double chins.

It is made by Allergan Aesthetics, the same manufacturers as the botulinum toxin brand, , and is marketed as BELKYRA® in the UK, Australia, Canada, and other countries. It has been approved in the USA since April 2015 where it is marketed under the brand name .

Prior to as a in both the USA and the UK, it was known in clinical trials as ATX-101, Thérascan thus many of the clinical papers about its safety and efficacy refer to it as ATX-101.

The active ingredient is 20 mg of deoxycholic acid in each 2ml vial of solution. There are 4 x 2ml vials in each per patient box of which should be enough to treat a single patient over the course of several sessions.

Each vial also contains water for injection, sodium chloride, sodium (for dissolution and pH adjustment), disodium phosphate anhydrous, and hydrochloric acid (for pH adjustment). The pH of the is 8.3, making it slightly and on a level with sea water.

The note that acid is a drug. When it is into the subcutaneous layer where the fat sits, its of action is to disrupt the cell of the fat cells or adipocytes. By the fat cell walls and making them leak out their liquid fat content, or lipids, this stimulates a wound response in the body, which sets about the debris the and the body of the excess fat which has been targeted for removal. It also the production of new collagen in the area as a reaction to the trauma with further and the area.

During treatment, your practitioner will inject 0.2 ml (2 mg) per site into the subcutaneous level below the skin where the fat resides, points are spaced 1 cm apart under your chin and will be marked out prior to treatment. You will usually need more than one for optimal results.

To ensure comfort, the is usually performed using either cream or local anaesthetic to numb the area being . A cold compress may also be .

BELKYRA® became widely available and in the UK in 2021 following several years of clinical trial amongst UK physicians.

is licensed in the UK and indicated for “the treatment of moderate to severe convexity or fullness associated with submental fat in adults when the presence of submental fat has an important psychological impact for the patient“. 

The U.S. Food and Drug in America approved the product in April 2015 under the brand name KYBELLA® for the “improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults“.

The is not recommended for use in anyone under 18 years of age.

trained and members of the medical only. Currently only available on prescription through doctors.

BELKYRA is indicated for treating to severe fat, more commonly known as a double chin.

The idea is either male or female and is bothered by the area under their chin, they feel it makes them look older or heavier in appearance, and despite eating well and exercising the double chin or submental does not reduce.

Because with under the clinical trial name AXT-101 and the brand name of KYBELLA® has been available for longer in the USA, the long-term results from have been more thoroughly assessed. From the clinical trials, a subset of those have to be followed-up for further study and this has the continued effects of treatment for up to 5 years.

Very reported side following with include, redness, pain, swelling, itching, or bruising at the sites. Other common side effects include headache, nausea, a of tightness or warmth to the skin in the area . Most common reactions and discomfort resolve within days.

More severe and rare include nerve injuries, which can take a few months to .

You can take over-the-counter pain medication to ease discomfort after each .

Pregnant and women, or the under 18s.

Should not be used in anyone with a known sensitivity to deoxycholic acid or any of the other ingredients within the product. 

Treatment cannot take place if there is an active infection in the area to be treated.

Due to the inclusion of salt within the product, on a controlled sodium diet may not be for .

You will be recommended to have 2-4 up to a maximum of 6. These will be spaced at least 4 weeks apart.

The cost of treatment depends on the size of the area being treated and the amount of treatment sessions required. Be prepare for prices to be between £750-£1,000 per session.

The manufacturers have performed various randomised, double-blind, placebo-controlled trials at multi-centres across the USA, Canada, and Europe over the last decade to gather pivotal data for approval in the various territories. The U.S. and Phase III trials were known as REFINE-1 and REFINE-2 (Randomised Double-blind Evaluation of Submental Fat Reduction IN ATX-101 TrEated Patients) and enrolled more than 1,000 who were with ATX-101 or placebo, in 70 centres. Similar trials were in Europe.

The various trials have demonstrated results which show that 68.2% of subjects with experienced a ≥1-grade with the use of the compared to 20.5% of subjects; this was based upon and patient measurements. 16% of a ≥2- grade improvement, to 2% of who responded to placebo. Similarly, KYBELLA resulted in high satisfaction – 79% of reported satisfaction with their in association with their face and chin. Patients also reported in the visual and emotional impact of fat when asked how happy, bothered, self-conscious, embarrassed, old, and they felt following treatment in to the amount of their fat.

Improvements in Contour Up to 3 Years After ATX-101: and Safety of the Phase 3 REFINE Trials.

Humphrey S, Cohen JL, Bhatia AC, Green LJ, Green JB, Bowen B.

Aesthet Surg J. 2021 Feb 22:sjab100. 

Uncommon Adverse of Acid Injection for Submental Fullness: Beyond the Clinical Trials.

KC, Crowley EL, Kadlubowska D, Gooderham MJ.

J Cutan Med Surg. 2020 Nov/Dec;24(6): . Epub 2020 Aug 5.

acid in the submental fat reduction: A review of properties, adverse effects, and .

Farina GA, Cherubini K, de Figueiredo MAZ, Salum FG.

J Cosmet Dermatol. 2020 Oct;19(10): . Epub 2020 Jul 29.

Efficacy and safety of ATX-101 as a for fullness: A analysis of two practices.

M, Karavan M, Greene R, Fabi SG.

J Cosmet . 2020 Jun;19(6): . Epub 2019 Sep 25.

ATX-101 ( Acid Injection) Leads to Clinically Meaningful Improvement in Submental Fat: Final Data From CONTOUR.

Behr K, Kavali CM, Munavalli G, Teller CF, Yoelin S, Breshears L, Sangha S.

Surg. 2020 May;46(5): .  

Experience With 100 Consecutive Neck With ATX-101 ( Acid): An Report With A 2-Year Analysis.

Shridharani SM.

Surg. 2019 Oct;45(10): . 

ATX-101 (Deoxycholic Acid Injection) for of Submental Fat: Results From a 12-Month Open-Label Study.

Beer K, Weinkle SH, Cox SE, Rubin MG, A, Somogyif C.

J Drugs Dermatol. 2019 Sep 1;18(9): .

The Use of Deoxycholic Acid for the Clinical of Excess Submental Fat in Indian Patients.

Shome D, Khare S, Kapoor R.

J Drugs Dermatol. 2019 Mar 1;18(3): .

and Safety of ATX-101 by Treatment Session: Pooled of Data From the Phase 3 REFINE Trials.

Dayan SH, Schlessinger J, Beer K, LM, Jones DH, S, Carruthers J, Lizzul PF, Gross TM, Beddingfield FC 3rd, Somogyi C.

Surg J. 2018 Aug 16;38(9): .

ATX-101 ( Acid Injection) in Men: Insights From Our .

SM, Behr KL.

Surg. 2017 Nov;43 Suppl 2:S225-S230. 

The development, evidence, and current use of ATX-101 for the treatment of submental fat.

C, Lipner SR.

J Cosmet Dermatol. 2017 Jun;16(2): . Epub 2017 Apr 21.

Prevention and of Injection-Related in Facial Aesthetics: Considerations for ATX-101 (Deoxycholic Acid Injection) Treatment.

Fagien S, P, M, Jones DH.

Dermatol Surg. 2016 Nov;42 Suppl 1:S300-S304. 

Management of Patient Experience With ATX-101 ( Acid Injection) for Reduction of Submental Fat.

Dover JS, Kenkel JM, Carruthers A, Lizzul PF, Gross TM, M, FC 3rd.

Surg. 2016 Nov;42 Suppl 1:S288-S299. 

of ATX-101 ( Acid Injection): A Approach for Reduction of Submental Fat.Dayan SH, Humphrey S, Jones DH, Lizzul PF, Gross TM, Stauffer K, FC 3rd.

Surg. 2016 Nov;42 Suppl 1:S263-S270. 

REFINE-1, a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial With ATX-101, an Drug for Submental Fat .

Jones DH, Carruthers J, Joseph JH, VD, Walker P, Lee DR, Subramanian M, Lizzul PF, Gross TM, Beddingfield FC 3rd.

Dermatol Surg. 2016 Jan;42(1):38-49.

[The use of deoxycholic acid (ATX-101) in aesthetic medicine: A promising treatment].

Hersant B, Calmon A, Meningaud JP.

Rev Stomatol Chir Chir Orale. 2015 Dec;116(6):350-2. doi: 10.1016/j.revsto.2015.09.003. Epub 2015 Dec 1.

Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic of excess submental fat.

J, Ruiz JB, Lee D, Lippert S, C, B.

Aesthetic Plast Surg. 2014 Oct;38(5):849-60. Epub 2014 Jul 2.

Efficacy, patient-reported outcomes and safety profile of ATX-101 ( acid), an injectable drug for the reduction of fat: results from a phase III, randomized, placebo-controlled study.

Ascher B, K, Walker P, Lippert S, Wollina U, Havlickova B.

J Eur Acad . 2014 Dec;28(12): . Epub 2014 Mar 8.

Reduction of fat with ATX-101 (deoxycholic acid), an adipocytolytic treatment: results from a phase III, randomized, placebo-controlled study.

Rzany B, T, Walker P, Lippert S, J, B.

Br J Dermatol. 2014 Feb;170(2):445-53.

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