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

NCT05249257 | Completed

• 1 other identifier: EN3835-225
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Cellulite; Laxity; Skin; Edematous Fibrosclerotic Panniculopathy

Outcome Measures

Primary Outcomes (2)

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

  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

  Day 360

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

  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

  Day 540

Secondary Outcomes (3)

• I-GAIS ratings

  Day 360 and Day 540

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

  Day 360 and Day 540

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

  Day 360 and Day 540

Study Arms (1)

No Treatment - previously treated in parent study

Participants who completed the parent study EN3835-224 (NCT04580303) will be eligible for this study.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The Safety Population is defined as all participants who meet the inclusion/exclusion criteria at Day 360. All Safety analyses will be based on this population. The Full Analysis Set (FAS) is defined as all participants in the Safety Population who have at least 1 I-GAIS assessment. All efficacy analyses will be based on this population.

You may qualify if:

• Have participated in and completed study EN3835-224 (parent study).
• Be willing and able to cooperate with the requirements of the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (3)

Endo Clinical Trial Site #2

Coral Gables, Florida, 33146, United States

Location

Endo Clinical Trial Site #3

Metairie, Louisiana, 70006, United States

Location

Endo Clinical Trial Site #1

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Cellulite; Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Karen Chajko

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 21, 2022
• Study Start: January 25, 2022
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)