Patient Experience Study of Deoxycholic Acid Injection

Kythera Biopharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Moderate or Severe Submental Fullness

Treatments: Drug: Placebo; Drug: Lidocaine / Epinephrine; Drug: Deoxycholic Acid Injection; Drug: Loratadine; Drug: Ibuprofen; Other: Cold Compress; Other: Compression Chin Strap

Study type: Interventional

Funder types: Industry

Identifiers

NCT02007434

ATX-101-13-36

Details and patient eligibility

About

The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema.

Full description

This study evaluated the effects of four interventions, pre- and post-subcutaneous injections of deoxycholic acid injection relative to placebo in adults with submental fullness. Participants were randomized to either deoxycholic acid injection or placebo in a ratio of 4:1 and to one of four patient experience management paradigms.

Participants were required to visit the research facility on 10 separate occasions for protocol-defined treatments, procedures, tests, and observations.

Enrollment: 84 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Submental fat graded by the Investigator as 2 (moderate) or 3 (severe) using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 (moderate amount) or 3 (large amount) using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
2. Dissatisfaction with the appearance of the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS)
3. History of stable body weight for at least 6 months and body mass index (BMI) of ≤ 40 kg/m².
4. Acceptable skin laxity as determined by the investigator
5. Agreement by the subject to refrain from making significant changes, in the documented judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation.
6. Agreement to forego any treatment or behavior (e.g., unshaven facial hair)
7. Signed informed consent obtained before any study-specific procedure is performed.

Exclusion criteria

1. No prior intervention for submental fullness or recent cosmetic procedure in the neck or chin area
2. Absence of clinically significant health problems
3. Body mass index > 40.0 kg/m² as determined prior to randomization.
4. History of drug or alcohol abuse.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 8 patient groups, including a placebo group

Paradigm 1 / Deoxycholic Acid Injection

Experimental group

Description:

Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL (based on Baseline CR-SMFRS grade 2 or 3, respectively) on Day 0 and a cold compress applied to the treatment area.

Treatment:

Other: Cold Compress

Drug: Deoxycholic Acid Injection

Paradigm 1/ Placebo

Placebo Comparator group

Description:

Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.

Treatment:

Other: Cold Compress

Drug: Placebo

Paradigm 2 / Deoxycholic Acid Injection

Experimental group

Description:

Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.

Treatment:

Drug: Lidocaine / Epinephrine

Other: Cold Compress

Drug: Deoxycholic Acid Injection

Paradigm 2 / Placebo

Placebo Comparator group

Description:

Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.

Treatment:

Drug: Lidocaine / Epinephrine

Other: Cold Compress

Drug: Placebo

Paradigm 3 / Deoxycholic Acid Injection

Experimental group

Description:

Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.

Treatment:

Drug: Ibuprofen

Drug: Lidocaine / Epinephrine

Other: Cold Compress

Drug: Deoxycholic Acid Injection

Drug: Loratadine

Paradigm 3 / Placebo

Placebo Comparator group

Description:

Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.

Treatment:

Drug: Ibuprofen

Drug: Lidocaine / Epinephrine

Other: Cold Compress

Drug: Placebo

Drug: Loratadine

Paradigm 4 / Deoxycholic Acid Injection

Experimental group

Description:

Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.

Treatment:

Drug: Ibuprofen

Drug: Lidocaine / Epinephrine

Other: Cold Compress

Drug: Deoxycholic Acid Injection

Other: Compression Chin Strap

Drug: Loratadine

Paradigm 4 / Placebo

Placebo Comparator group

Description:

Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.

Treatment:

Drug: Ibuprofen

Drug: Lidocaine / Epinephrine

Other: Cold Compress

Drug: Placebo

Other: Compression Chin Strap

Drug: Loratadine