Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Dose-Escalation Study of the Pharmacokinetics, Safety, and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas
Overview
- Phase
- Phase 1
- Intervention
- Deoxycholic Acid Injection
- Conditions
- Lipoma
- Sponsor
- Kythera Biopharmaceuticals
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Assessments of Safety with Laboratory tests
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this research is to compare the safety and effectiveness of 4 different concentrations of deoxycholic acid injection against a placebo in the treatment of superficial lipomas.
Detailed Description
A lipoma is a fatty lump typically located on the trunk, shoulder, arms or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)
Investigators
Eligibility Criteria
Inclusion Criteria
- •One or more lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:
- •History of slow growth followed by dormancy, and stable for at least 6 months.
- •Greatest length by greatest perpendicular width between 1 and 16 square centimeters, inclusive
- •Discrete, oval to rounded in shape, not hard or attached to underlying tissue
- •Located on the trunk, arms, legs, or neck
- •Stable body weight with a body mass index of less than 30 kg/m²
- •Signed informed consent
Exclusion Criteria
- •Absence of significant medical conditions that could affect safety
- •History of surgical treatment for lipomas
- •Treatment with an investigational agent within 30 days before ATX-101 treatment
Arms & Interventions
Deoxycholic Acid Injection 0.5%
Participants received 0.5% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Intervention: Deoxycholic Acid Injection
Deoxycholic Acid Injection 1.0%
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Intervention: Deoxycholic Acid Injection
Deoxycholic Acid Injection 2.0%
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Intervention: Deoxycholic Acid Injection
Deoxycholic Acid Injection 4.0%
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Intervention: Deoxycholic Acid Injection
Placebo
Participants received matching vehicle placebo administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Intervention: Placebo
Outcomes
Primary Outcomes
Assessments of Safety with Laboratory tests
Time Frame: up to 16 weeks
Assessments of Safety with ECG
Time Frame: up to 16 weeks
Assessments of Safety with Medical Evaluations
Time Frame: up to 16 weeks
Secondary Outcomes
- Lipoma size reduction(up to 16 weeks)