Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
84 participants
INTERVENTIONAL
2013-12-31
2014-06-30
Brief Summary
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Detailed Description
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Participants were required to visit the research facility on 10 separate occasions for protocol-defined treatments, procedures, tests, and observations.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Paradigm 1 / Deoxycholic Acid Injection
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.
Deoxycholic Acid Injection
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Cold Compress
A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.
Paradigm 1/ Placebo
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.
Placebo
Phosphate buffered saline placebo for injection
Cold Compress
A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.
Paradigm 2 / Deoxycholic Acid Injection
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.
Deoxycholic Acid Injection
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Cold Compress
A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.
Lidocaine / Epinephrine
Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing.
Paradigm 2 / Placebo
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.
Placebo
Phosphate buffered saline placebo for injection
Cold Compress
A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.
Lidocaine / Epinephrine
Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing.
Paradigm 3 / Deoxycholic Acid Injection
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.
Deoxycholic Acid Injection
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Cold Compress
A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.
Lidocaine / Epinephrine
Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing.
Loratadine
Loratadine 10 mg orally from Day -7 until Day 7
Ibuprofen
Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.
Paradigm 3 / Placebo
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.
Placebo
Phosphate buffered saline placebo for injection
Cold Compress
A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.
Lidocaine / Epinephrine
Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing.
Loratadine
Loratadine 10 mg orally from Day -7 until Day 7
Ibuprofen
Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.
Paradigm 4 / Deoxycholic Acid Injection
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.
Deoxycholic Acid Injection
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Cold Compress
A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.
Lidocaine / Epinephrine
Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing.
Loratadine
Loratadine 10 mg orally from Day -7 until Day 7
Ibuprofen
Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.
Compression Chin Strap
A compression chin strap was applied 15 minutes after dosing for at least 24 hours.
Paradigm 4 / Placebo
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.
Placebo
Phosphate buffered saline placebo for injection
Cold Compress
A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.
Lidocaine / Epinephrine
Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing.
Loratadine
Loratadine 10 mg orally from Day -7 until Day 7
Ibuprofen
Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.
Compression Chin Strap
A compression chin strap was applied 15 minutes after dosing for at least 24 hours.
Interventions
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Deoxycholic Acid Injection
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Placebo
Phosphate buffered saline placebo for injection
Cold Compress
A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.
Lidocaine / Epinephrine
Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing.
Loratadine
Loratadine 10 mg orally from Day -7 until Day 7
Ibuprofen
Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.
Compression Chin Strap
A compression chin strap was applied 15 minutes after dosing for at least 24 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Kythera Biopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Frederick Beddingfield, III, MD, PhD
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Investigational Site
Tempe, Arizona, United States
Countries
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References
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Dover JS, Kenkel JM, Carruthers A, Lizzul PF, Gross TM, Subramanian M, Beddingfield FC 3rd. Management of Patient Experience With ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat. Dermatol Surg. 2016 Nov;42 Suppl 1:S288-S299. doi: 10.1097/DSS.0000000000000908.
Other Identifiers
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ATX-101-13-36
Identifier Type: -
Identifier Source: org_study_id
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