A Study to Assess Injection Comfort of Two Formulations of ATX-101

Healthy Clinical Trial

Official title:

A Study to Assess Injection Comfort of Two Formulations of ATX-101 (Sodium Deoxycholate Injection) Following Subcutaneous Administration in the Submental Area

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320761
• Other study ID #: ATX-101-10-19
• Status: Completed
• Phase: Phase 1
• First received: March 18, 2011
• Last updated: March 21, 2011

Study information

• Verified date: March 2011
• Source: Kythera Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To assess the safety and injection comfort of ATX-101-BA versus ATX-101-BA-free immediately following injection and at regular intervals up to 24-hours post-injection following subcutaneous administration into the submental area.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Presence of submental fat graded by the investigator as 2, 3, or 4 using the CR-SMFRS (Appendix B).

2. Sufficient and symmetrical submental fat such that the protocol-specified number of injections can be safely administered on both the right and left side.

3. No difference in perception or sensitivity (pain or otherwise) between left and right sides of the submental area.

4. Abstinence from alcohol for at least 6 hours prior to both the Baseline and 24-hour visits.

5. Males or nonpregnant, nonlactating females who are aged 18 to 65 years, inclusive, on Baseline date.

6. Females of child-bearing potential must have a negative urine human chorionic gonadotropin (hCG) test result from a sample obtained during the screening period. Females of childbearing potential must agree to practice adequate contraception, in the judgment of the investigator, during the course of the trial (including post-screening).

7. The subject is expected to comply with and understand the visit schedule and all of the protocol-specified tests and procedures.

8. The subject is medically able to undergo the administration of study material as determined by clinical and laboratory evaluations obtained within 14 days before dosing with study material for which the investigator identifies no clinically significant abnormality.

9. Signed informed consent obtained before any study-specific procedure is conducted.

Exclusion Criteria:

1. History of any intervention (e.g., liposuction) or trauma associated with the chin or neck areas, which in the judgment of the investigator, may affect subject safety or other evaluations of treatment.

2. Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement, cervical adenopathy) other than localized submental fat.

3. Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, thyroid dysfunction), that would interfere with the assessment of safety in this trial or would compromise the ability of the subject to undergo study procedures or to give informed consent.

4. Any cognitive impairment that, in the Investigator's opinion, would preclude study participation or compliance with protocol-specified procedures.

5. Treatment with analgesics or other agents that could affect the pain response, including but not limited to acetaminophen or ibuprofen taken within 1 day prior to Baseline; additionally, narcotic analgesics, tranquilizers, hypnotics, sedatives, or opiates within 7 days prior to Baseline.

6. Treatment of the chin or SMF with injectable steroids within 90 days prior to Baseline.

7. Participation in a pain study within 6 months prior to Baseline.

8. History of chronic pain and/or a history of chronic analgesic or tranquilizer use within 90 days prior to Baseline.

9. Any anticipated need for agents with anticoagulative effects (e.g., aspirin, ibuprofen, warfarin, heparin) during the course of the trial.

10. Treatment with oral anticoagulants (e.g., aspirin, warfarin) within 10 days prior to Baseline.

11. Treatment with topical agents to the submental or neck area, including but not limited to creams or ointments used to treat dermatologic conditions (e.g., steroids, capsaicin, retinoids, fluorouracil) within 7 days prior to Baseline.

12. Treatment with radio frequency, laser procedures, chemical peel, or dermal fillers in the neck or chin area within 12 months before dosing or botulinum toxin injections within 6 months prior to Baseline.

13. Previous enrollment into this trial or treatment with ATX-101 or agents containing deoxycholate.

14. Treatment with an investigational agent within 28 days prior to Baseline.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ATX-101-BA-free
ATX-101-BA-free
• ATX-101-BA
ATX-101-BA

Locations

Country	Name	City	State
United States	Joel Schlessinger, M.D.	Omaha	Nebraska
United States	Jeffrey M. Adelglass, M.D.	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Kythera Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort measure	The primary measure of comfort is the pain comparison scale between ATX-101-BA and ATX-101-BA-free at the time of injection using the pain comparison scale and the VAS pain rating scale.	up to 24 hours after treatment	No