CompletedPhase 2

Injection Techniques of Collagenase Clostridium Histolyticum (CCH) for the Treatment of EFP (Cellulite)

United States64 participantsStarted 2018-09-18

Plain-language summary

The study will evaluate the safety and effectiveness of different injection techniques of Collagenase Clostridium Histolyticum (CCH) for the treatment of adult women with mild, moderate or severe Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Be able to provide voluntary written informed consent prior to the initiation of any study specific procedures per the policy of the governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
. Be female and at least 18 years of age at the time of consent.
. Have evidence of cellulite in 2 bilateral treatment areas (defined as right and left buttocks or right and left posterolateral thighs) as assessed by the Investigator at the Screening visit, and fulfills the following requirements:
. has a score of 2 (mild), 3 (moderate) or 4 (severe) as reported by the Investigator (CR-PCSS) in 2 treatment areas (two thighs or two buttocks) at the Screening Visit.
. has at least 2 dimples from each treatment area that:
. Be willing to apply sunscreen to the dosing areas before each exposure to the sun while participating in the study (that is, screening through end of study).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22

Timeframe: Day 22

Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43

Timeframe: Day 43

Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71

Timeframe: Day 71

Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22

Timeframe: Baseline, Day 22

Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43

Timeframe: Baseline, Day 43

Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71

Timeframe: Baseline, Day 71

Trial details

NCT IDNCT03632993

SponsorEndo USA Inc., a Keenova Therapeutics Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-24

Results submitted2022-05-27

View on ClinicalTrials.gov More Edematous Skin trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Be able to provide voluntary written informed consent prior to the initiation of any study specific procedures per the policy of the governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
. Be female and at least 18 years of age at the time of consent.
. Have evidence of cellulite in 2 bilateral treatment areas (defined as right and left buttocks or right and left posterolateral thighs) as assessed by the Investigator at the Screening visit, and fulfills the following requirements:
. has a score of 2 (mild), 3 (moderate) or 4 (severe) as reported by the Investigator (CR-PCSS) in 2 treatment areas (two thighs or two buttocks) at the Screening Visit.
. has at least 2 dimples from each treatment area that:
. Be willing to apply sunscreen to the dosing areas before each exposure to the sun while participating in the study (that is, screening through end of study).

What they're measuring

Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22

Timeframe: Day 22

Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43

Timeframe: Day 43

Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71

Timeframe: Day 71

Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22

Timeframe: Baseline, Day 22

Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43

Timeframe: Baseline, Day 43

Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71

Timeframe: Baseline, Day 71

Injection Techniques of Collagenase Clostridium Histolyticum (CCH) for the Treatment of EFP (Cellulite)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Injection Techniques of Collagenase Clostridium Histolyticum (CCH) for the Treatment of EFP (Cellulite)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria