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

Cellulite Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05249257
• Other study ID #: EN3835-225
• Status: Completed
• Start date: January 25, 2022
• Est. completion date: September 12, 2022

Study information

• Verified date: January 2023
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 12, 2022
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Have participated in and completed study EN3835-224 (parent study).

2. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

1. Has received any collagenase treatments (eg, Santyl® Ointment) at any time since

2. 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.

3. Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study

Related Conditions & MeSH terms

• Cellulite
• Edematous Fibrosclerotic Panniculopathy
• Laxity; Skin

Locations

Country	Name	City	State
United States	Endo Clinical Trial Site #2	Coral Gables	Florida
United States	Endo Clinical Trial Site #3	Metairie	Louisiana
United States	Endo Clinical Trial Site #1	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	I-GAIS ratings	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.	Day 360 and Day 540
Secondary	Proportion of 1-level responders (+1 or better score) on the S-GAIS for either buttock or either thigh	Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-level scale ranging from "+3" (very much improved) to a "-3" (very much worse).	Day 360 and Day 540
Secondary	Change from Day 1 (pre-treatment) of the parent study and each study visit in Subsection D of the Hexsel CSS	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).	Day 360 and Day 540