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

This study has been completed.
Sponsor:
Information provided by:
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01320761
First received: March 18, 2011
Last updated: March 21, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: ATX-101-BA-free
Drug: ATX-101-BA
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Assess Injection Comfort of Two Formulations of ATX-101 (Sodium Deoxycholate Injection) Following Subcutaneous Administration in the Submental Area

Further study details as provided by Kythera Biopharmaceuticals:

Primary Outcome Measures:
  • Comfort measure [ Time Frame: up to 24 hours after treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Arms Assigned Interventions
Experimental: Group 1A

Left side injected first:

Left submental - ATX-101-BA Right submental - ATX-101-BA-free

Drug: ATX-101-BA-free
ATX-101-BA-free
Drug: ATX-101-BA
ATX-101-BA
Experimental: Group 1B

Right side injected first:

Left submental - ATX-101-BA Right submental - ATX-101-BA-free

Drug: ATX-101-BA-free
ATX-101-BA-free
Drug: ATX-101-BA
ATX-101-BA
Experimental: Group 2A

Left side injected first:

Left submental - ATX-101-BA-free Right submental - ATX-101-BA

Drug: ATX-101-BA-free
ATX-101-BA-free
Drug: ATX-101-BA
ATX-101-BA
Experimental: Group 2B

Right side injected first:

Left submental - ATX-101-BA-free Right submental - ATX-101-BA

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320761

Locations
United States, Nebraska
Joel Schlessinger, M.D.
Omaha, Nebraska, United States, 68144
United States, Texas
Jeffrey M. Adelglass, M.D.
Plano, Texas, United States, 75093
Sponsors and Collaborators
Kythera Biopharmaceuticals
Investigators
Study Director: Patricia Walker, M.D. Kythera Biopharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Daniel R. Lee, M.S., Director, Clinical Affairs, Kythera Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01320761     History of Changes
Other Study ID Numbers: ATX-101-10-19
Study First Received: March 18, 2011
Last Updated: March 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Kythera Biopharmaceuticals:
Formulation Comparison

ClinicalTrials.gov processed this record on July 20, 2014