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Completed

NCT Number: NCT04381117

Long-term Durability Study of Collagenase Clostridium Histolyticum (CCH)

This study will evaluate the long-term safety and duration of efficacy of CCH in the treatment of women with cellulite. This study will be a single day evaluation, approximately 48 months after the first dose of study drug was received in the EN3835-201.

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Key information

Conditions

Edematous Fibrosclerotic Panniculopathy Cellulite Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Clinical Trial Site #4, Clearwater, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have participated in and completed studies EN3835-201, EN3835-202 and EN3835-219 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201.
  • Be willing and able to cooperate with the requirements of the study.

Exclusion criteria

  • Has had retreatment with CCH in the area initially treated during the EN3835-201 study since the completion of study EN3835-219.
  • Has received collagenase treatments (eg, Santyl® Ointment and/or Xiaflex®/Xiapex®) since the completion of study EN3835-219.
  • Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study.
  • Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-201 study since the completion of that study.
  • Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.

Treatment and study plan

Previously Treated with EN3835

Drug

No treatment to be administered - Observational only

Primary outcomes

  1. CR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study

    Time frame: Approximately 4 weeks

    Clinician Reported-Photonumeric Cellulite Severity Scale is a 5-level photonumeric scale with ratings ranging from 0 (None) to 4 (Severe)

  2. PR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study

    Time frame: Approximately 4 weeks

    Patient Reported-Photonumeric Cellulite Severity Scale is a 5-level photonumeric scale with ratings ranging from 0 (None) to 4 (Severe)

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

A Phase 2b, Open-label Long-term Durability Study of CCH Following Treatment of Edematous Fibrosclerotic Panniculopathy (Cellulite)

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 8, 2020
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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