A Phase 2, Randomized, Double-blind, Placebo Controlled Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy

NCT01987986 | Completed Phase 2 Results

• 1 other identifier: AUX-CC-831
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 10

Brief Summary

To assess the safety and effectiveness of repeat doses of AA4500 in the treatment of edematous fibrosclerotic panniculopathy (EFP) commonly known as cellulite in adult women.

Conditions

Edematous Fibrosclerotic Panniculopathy (EFP)

Keywords

cellulite; dimple; orange peel; cottage cheese; mattress texture

Outcome Measures

Primary Outcomes (1)

• Investigator Global Assessment of Aesthetic Improvement

  Investigators assessment of aesthetic improvement (I-GAIS) scores ranged from 3 to -1 as follows: 3 (very much improved), 2 (much improved), 1 (improved), 0 (no change), -1 (worse).

  Baseline, Day 73

Other Outcomes (7)

• Investigator Cellulite Severity Score (CSS) Total Score- Change From Baseline

  Baseline, Day 73

• Subject Cellulite Severity Item (CSI)-Change From Baseline

  Baseline, Day 73

• Subject Global Bother Assessment (SGBA)- Change From Baseline

  Baseline, Day 73

Study Arms (4)

AA4500 0.06 mg (low dose)

EXPERIMENTAL

AA4500 (Collagenase Clostridium Histolyticum) Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.

Biological: Collagenase Clostridium Histolyticum

AA4500 0.48 mg (mid-dose)

EXPERIMENTAL

AA4500 (Collagenase Clostridium Histolyticum) Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.

Biological: Collagenase Clostridium Histolyticum

AA4500 0.84 mg (high dose)

EXPERIMENTAL

AA4500 (Collagenase Clostridium Histolyticum) Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.

Biological: Collagenase Clostridium Histolyticum

Placebo

PLACEBO COMPARATOR

Placebo Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.

Biological: Placebo

Interventions

Collagenase Clostridium Histolyticum BIOLOGICAL

injectible intervention

Also known as: AA4500, Xiaflex, Xiapex

AA4500 0.06 mg (low dose); AA4500 0.48 mg (mid-dose); AA4500 0.84 mg (high dose)

Placebo BIOLOGICAL

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be a female between 18 to 45 years of age.
• Have at least one well defined dimple that is at least 1 cm but not more than 2 cm along the long axis and that is evident when the subject is standing
• Have a photonumeric cellulite severity scale (CSS) score between 6 and 12
• Have a Body Mass Index (BMI) \>19 and \<30 kg/m2, and intends to maintain stable body weight throughout the duration of the study
• Be willing to apply appropriate sunscreen to the selected quadrant before each exposure to the sun while participating in the study
• 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.
• Be willing and able to cooperate with the requirements of 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).
• Be able to read, complete and understand the Patient Reported Outcomes rating instruments in English.

You may not qualify if:

• 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
• Cushing's disease and/or use of systemic corticosteroids
• 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 a medication for chronic anticoagulation (except for ≤ 150 mg aspirin daily)
• Known active hepatitis A, B or C

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (10)

Dermatology Cosmetic Laser Medical Associates of La Jolla

San Diego, California, 92121, United States

Location

ATS Clinical Research

Santa Monica, California, 90404, United States

Location

Dermatology Research Institute

Coral Gables, Florida, 33146, United States

Location

Kenneth Beer, MD PA

West Palm Beach, Florida, 33401, United States

Location

Mercy Health Research

Washington, Missouri, 63090, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Charlottesville Dermatology

Charlottesville, Virginia, 22911, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Cellulite

Interventions

Microbial Collagenase; xiapex

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals Inc.

clinicalsite.inquires@endo.com

Study Officials

• Veronica Urdaneta, MD MPH

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 20, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 5, 2017
• Results First Posted: July 2, 2017

Record last verified: 2017-09

Locations

US (10)