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Completed

NCT Number: NCT05249257

Durability and Safety of CCH With Two Different Injection Techniques in Cellulite With Laxity

All participants who completed the EN3835-224 study will be invited to participate in this observational study to evaluate long term durability of response and safety.

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Key information

Conditions

Cellulite Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Edematous Fibrosclerotic Panniculopathy Genetic Diseases, Inborn Laxity; Skin Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Diseases, Genetic Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Endo Clinical Trial Site #2, Coral Gables, 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 study EN3835-224 (parent study).
  • Be willing and able to cooperate with the requirements of the study.

Exclusion criteria

  • Has received any collagenase treatments (eg, Santyl® Ointment) at any time since
  • Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-224 study since the completion of that study.
  • Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study

Treatment and study plan

Primary outcomes

  1. Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh

    Time frame: Day 360

    Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to "-3" (very much worse) to determine the degree of improvement of the treated areas

  2. Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh

    Time frame: Day 540

    Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to "-3" (very much worse) to determine the degree of improvement of the treated areas

Secondary outcomes

  1. I-GAIS ratings

    Time frame: Day 360 and Day 540

    Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to a "-3" (very much worse) to determine the degree of improvement of the treated areas.

  2. Proportion of 1-level responders (+1 or better score) on the S-GAIS for either buttock or either thigh

    Time frame: Day 360 and Day 540

    Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-level scale ranging from "+3" (very much improved) to a "-3" (very much worse).

  3. Change from Day 1 (pre-treatment) of the parent study and each study visit in Subsection D of the Hexsel CSS

    Time frame: Day 360 and Day 540

    Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite using a 4-point scale ranging from "0" (low) to "3" (high).

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

A Phase 2, Multicenter, Observational Study to Assess the Durability and Safety of Collagenase Clostridium Histolyticum Injected With GRID Technique in Buttocks or Thigh Cellulite With Laxity in Adult Females

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2022
Registry last updated
Jan 19, 2023

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

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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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