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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05249257

Enrollment

Registered

2022-02-21

Start date

2022-01-25

Completion date

2022-09-12

Last updated

2023-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cellulite, Edematous Fibrosclerotic Panniculopathy, Laxity; Skin

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	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).
I-GAIS ratings	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.
Proportion of 1-level responders (+1 or better score) on the S-GAIS for either buttock or either thigh	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).

Countries

United States

Outcome results