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NCT01987986 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Edematous Fibrosclerotic Panniculopathy (EFP), sponsored by Endo Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
150
Enrollment target
10
Study locations

NCT01987986: Completed Phase 2 study of Edematous Fibrosclerotic Panniculopathy (EFP), sponsored by Endo Pharmaceuticals.

NCT01987986 is a Phase 2 study of Edematous Fibrosclerotic Panniculopathy (EFP) that has completed, run by Endo Pharmaceuticals. The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01987986, a Phase 2 study of Edematous Fibrosclerotic Panniculopathy (EFP), has completed, sponsored by Endo Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
150 participants
Enrollment target
10
Study locations

Study 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.

Primary Outcome

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).

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Collagenase Clostridium Histolyticum

Study Locations (10)

California

  • Dermatology Cosmetic Laser Medical Associates of La Jolla - San Diego
  • ATS Clinical Research - Santa Monica

Florida

  • Dermatology Research Institute - Coral Gables
  • Kenneth Beer, MD PA - West Palm Beach

New York

  • Sadick Research Group - New York
  • Stony Brook University Medical Center - Stony Brook

Missouri

  • Mercy Health Research - Washington

Tennessee

  • Tennessee Clinical Research Center - Nashville

Virginia

  • Charlottesville Dermatology - Charlottesville

Washington

  • Premier Clinical Research - Spokane

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2013-10
Est. Completion 2014-08
Phase Phase 2
Endo Pharmaceuticals

23 total trials

What the finished NCT01987986 record still lists

NCT01987986 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).

The record links to 1 condition, with Edematous Fibrosclerotic Panniculopathy (EFP) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01987986 lists 10 locations in 7 states (California, Florida, New York).

Frequently Asked Questions

What is clinical trial NCT01987986 about?

NCT01987986 is a clinical study titled "A Phase 2, Randomized, Double-blind, Placebo Controlled Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy". 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.

What is the current status of trial NCT01987986?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2013-10. Estimated completion is 2014-08.

What conditions does trial NCT01987986 study?

This clinical trial studies the following conditions: Edematous Fibrosclerotic Panniculopathy (EFP).

What interventions are being tested in trial NCT01987986?

The interventions under investigation include: Placebo (BIOLOGICAL), Collagenase Clostridium Histolyticum (BIOLOGICAL).

Who is sponsoring clinical trial NCT01987986?

This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01987986 being conducted?

This trial has 10 study locations across California, Florida, Missouri, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01987986's enrollment target sits among peer trials

150 455th of 2000 higher than 1,510 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01987986, the US trial registry maintained by the National Library of Medicine. NCT01987986 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.