The Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
A Phase 1b, Open-label, Dose-escalation Study of the Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy Commonly Known as Cellulite
1 other identifier
interventional
99
1 country
1
Brief Summary
This study will evaluate the safety, effectiveness, pharmacokinetics, and immunogenicity of AA4500 at increasing doses and concentrations in the treatment of adult women with cellulite.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 24, 2012
CompletedFirst Posted
Study publicly available on registry
January 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMarch 19, 2015
March 1, 2015
11 months
January 24, 2012
March 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Investigator global aesthetic improvement scale assessment of the target cellulite area
Day 90
Subject global aesthetic improvement scale assessment of the target cellulite area
Day 90
A responder analysis based on proportion of subjects with a ≥ 30% improvement from baseline in the absolute surface depth of the central dimple/depression based on 3D digital photography.
Day 90
Percent change from baseline in total absolute surface depth of the central dimple/depression based on 3D digital photography.
Day 90
Study Arms (11)
AA4500 0.0029 mg in 1 mL
EXPERIMENTALAA4500 0.0145 mg in 5 mL
EXPERIMENTALAA4500 0.0145 mg in 1 mL
EXPERIMENTALAA4500 0.0435 mg in 5 mL
EXPERIMENTALAA4500 0.0435 mg in 1 mL
EXPERIMENTALAA4500 0.116 mg in 5 mL
EXPERIMENTALAA4500 0.116 mg in 1 mL
EXPERIMENTALAA4500 0.232 mg in 5 mL
EXPERIMENTALAA4500 at 0.232 in 1 mL
EXPERIMENTALAA4500 0.464 mg in 5 mL
EXPERIMENTALAA4500 0.464 mg in 1 mL
EXPERIMENTALInterventions
Subdermal dose
Eligibility Criteria
You may qualify if:
- Be a female and be ≥ 21 years of age and ≤ 60 years of age
- Have a skin type classification of I through V according to the Fitzpatrick scale
- Have EFP within the posterolateral thigh(s) and/or buttock(s) for at least 12 months before the screening visit
- Have a photonumeric cellulite severity scale (CSS) score of ≥ 7 representing moderate to severe cellulite severity within the right or left buttock or the right or left posterolateral thigh (selected quadrant)
- Have an area of EFP within the selected quadrant that is at least 8 cm x 10 cm (ie, target EFP area) and is suitable for treatment:
- The target EFP area must be located on the posterolateral thigh or within the buttock and does not involve the gluteal fold
- The target EFP area must be evident when the subject is standing, without the use of any manipulation such as skin pinching or muscle contraction (ie, CSS Classification E score of 2 or 3) at screening and before injection
- Have a Body Mass Index (BMI) between 20.0 and 33.0 kg/m2, and intends to maintain stable body weight throughout the duration of the study (a variation of ≤5% from baseline body weight is permitted)
- Be willing to refrain from using artificial tanning devices and lotions during the 2-week period before screening and throughout the duration of the study
- Be willing to apply sunscreen with sun protection factor (SPF) ≥15 to the selected quadrant before each exposure to the sun while participating in the study (ie, screening through Day 90)
- Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening
- Have a negative urine pregnancy test at screening and before injection of AA4500 and be using an effective contraception method (ie, abstinence, intrauterine device \[IUD\], hormonal \[estrogen/progestin\] contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for the duration of the study, or be surgically sterile, or be a postmenopausal female (no menses for at least 1 year or hysterectomy)
- Be willing and able to cooperate with the requirements of the study including requirements during the confinement period and throughout the study
- Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC). The subject must also sign an authorization form to allow disclosure of her protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution
- Be able to complete and understand the various rating instruments in English
You may not qualify if:
- Has any of the following conditions:
- Thyroid disease, unless controlled with medication for ≥ 6 months
- Uncontrolled diabetes mellitus, as determined by the investigator
- Uncontrolled hypertension, as determined by the investigator
- Vascular disorder (eg, phlebitis or varicose veins) in area to be treated
- Lipedema or a lymphatic disorder
- History of lower extremity thrombosis or post-thrombosis syndrome
- Documented autoimmune disorder such as lupus erythematosus, rheumatoid arthritis
- Inflammation or active infection in area to be treated
- Cutaneous alteration in area to be treated
- Rash, eczema, psoriasis, or skin cancer in the area to be treated
- History of keloidal scarring or abnormal wound healing
- Coagulation disorder; taking an anticoagulant (except for ≤ 150 mg aspirin daily) up to 7 days prior to injection day
- Known active hepatitis B or C (history of hepatitis A is permitted)
- Known immune deficiency disease or a positive test for human immunodeficiency virus (HIV)
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SNBL Clinical Pharmacology Center, Inc
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Veronica Urdaneta, MD MPH
Endo Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2012
First Posted
January 26, 2012
Study Start
January 1, 2012
Primary Completion
December 1, 2012
Study Completion
February 1, 2013
Last Updated
March 19, 2015
Record last verified: 2015-03