KYBELLA DEOXYCHOLIC ACID FAT REMOVAL SOLUTION
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NavyChief
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- Sep 26, 2013
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Clinical Studies
Two randomized, multi-center, double-blind, placebo-controlled trials of identical design were conducted to evaluate KYBELLA® (deoxycholic acid) injection for use in improvement in the appearance of convexity or fullness associated with submental fat. The trials enrolled healthy adults (ages 19 to 65, BMI ≤ 40 kg/m²) with moderate or severe convexity or fullness associated with submental fat (i.e., grade 2 or 3 on 5-point grading scales, where 0 = none and 4 = extreme), as judged by both clinician and subject ratings. Subjects received up to 6 treatments with KYBELLA® (N=514, combined trials) or placebo (N=508, combined trials) at no less than 1 month intervals. Use of ice/cold packs, topical and/or injectable local anesthesia was allowed during the clinical trials. Injection volume was 0.2 mL per injection site, spaced 1 cm apart into the submental fat tissue, which is also expressed in dose per area as 2 mg/cm². For each treatment session a maximum of 100 mg (10 mL) was permitted over the entire treatment area.
Subjects were administered an average of 6.4 mL at the first treatment session, and subjects who received all six treatments were administered an average of 4.4 mL at the sixth treatment session. Fifty-nine percent of subjects received all six treatments.
In these trials, the mean age was 49 years and the mean BMI was 29 kg/m². Most of the subjects were women (85%) and Caucasian (87%). At baseline, 51% of the subjects had a clinician-rated submental fat severity rating of moderate and 49% had a severe submental fat rating.
The co-primary efficacy assessments were based on at least 2-grade and at least 1-grade improvements in submental convexity or fullness on the composite of clinician-reported and patient-reported ratings of submental fat 12 weeks after final treatment. Additionally, changes in submental fat volume were evaluated in a subset of subjects (N=449, combined trials) using magnetic resonance imaging (MRI). Visual and emotional impacts of submental fat (happy, bothered, self-conscious, embarrassed, looking older or overweight) were also evaluated using a 6-question survey, with each question rated from 0 (not at all) to 10 (extremely/very much).
Reductions in submental fat volume were observed more frequently in the KYBELLA® group compared to the placebo group as measured by the composite clinician and patient ratings (Table 2).
Do not inject KYBELLA® outside the defined parameters [see WARNINGS AND PRECAUTIONS].
rxlist.com/kybella-drug.htm#indications_dosage
Two randomized, multi-center, double-blind, placebo-controlled trials of identical design were conducted to evaluate KYBELLA® (deoxycholic acid) injection for use in improvement in the appearance of convexity or fullness associated with submental fat. The trials enrolled healthy adults (ages 19 to 65, BMI ≤ 40 kg/m²) with moderate or severe convexity or fullness associated with submental fat (i.e., grade 2 or 3 on 5-point grading scales, where 0 = none and 4 = extreme), as judged by both clinician and subject ratings. Subjects received up to 6 treatments with KYBELLA® (N=514, combined trials) or placebo (N=508, combined trials) at no less than 1 month intervals. Use of ice/cold packs, topical and/or injectable local anesthesia was allowed during the clinical trials. Injection volume was 0.2 mL per injection site, spaced 1 cm apart into the submental fat tissue, which is also expressed in dose per area as 2 mg/cm². For each treatment session a maximum of 100 mg (10 mL) was permitted over the entire treatment area.
Subjects were administered an average of 6.4 mL at the first treatment session, and subjects who received all six treatments were administered an average of 4.4 mL at the sixth treatment session. Fifty-nine percent of subjects received all six treatments.
In these trials, the mean age was 49 years and the mean BMI was 29 kg/m². Most of the subjects were women (85%) and Caucasian (87%). At baseline, 51% of the subjects had a clinician-rated submental fat severity rating of moderate and 49% had a severe submental fat rating.
The co-primary efficacy assessments were based on at least 2-grade and at least 1-grade improvements in submental convexity or fullness on the composite of clinician-reported and patient-reported ratings of submental fat 12 weeks after final treatment. Additionally, changes in submental fat volume were evaluated in a subset of subjects (N=449, combined trials) using magnetic resonance imaging (MRI). Visual and emotional impacts of submental fat (happy, bothered, self-conscious, embarrassed, looking older or overweight) were also evaluated using a 6-question survey, with each question rated from 0 (not at all) to 10 (extremely/very much).
Reductions in submental fat volume were observed more frequently in the KYBELLA® group compared to the placebo group as measured by the composite clinician and patient ratings (Table 2).
Do not inject KYBELLA® outside the defined parameters [see WARNINGS AND PRECAUTIONS].
- Using a large bore needle, draw 1 mL of KYBELLA® into a sterile 1 mL syringe and expel any air bubbles in the syringe barrel.
- Have the patient tense the platysma. Pinch the submental fat and, using a 30 gauge (or smaller) 0.5 inch needle, inject 0.2 mL of KYBELLA® into the pre-platysmal fat (see Figure 2) next to each of the marked injection sites by advancing the needle perpendicular to the skin.
- Injections that are too superficial (into the dermis) may result in skin ulceration and necrosis. Do not withdraw the needle from the subcutaneous fat during injection as this could increase the risk of intradermal exposure and potential skin ulceration and necrosis.
- Avoid injecting into the post-platysmal fat by injecting KYBELLA® into fat tissue at the depth of approximately mid-way into the subcutaneous fat layer (Figure 2).
- If at any time resistance is met as the needle is inserted, indicating the possibility of contact with fascial or nonfat tissue, the needle must be withdrawn to an appropriate depth before the injection is administered.
- Avoid injecting into other tissues such as the muscle, salivary glands and lymph nodes.
- Upon needle withdrawal, pressure may be applied to each injection site as necessary to minimize bleeding; an adhesive dressing may be applied.
rxlist.com/kybella-drug.htm#indications_dosage
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