CompletedPhase 1

Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP

United States12 participantsStarted 2018-09-18

Plain-language summary

This study will evaluate the safety and Pharmacokinetics (PK) of a single 3.36-mg dose of Collagenase Clostridium Histolyticum (CCH) in 4 quadrants concurrently, in subjects with Edematous fibrosclerotic panniculopathy (EFP). This study will provide insight to the PK profile and safety of concurrent subcutaneous injections of CCH 0.84 mg/quadrant into 4 quadrants.

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 a female ≥18 years of age.
. Have evidence of cellulite within 4 quadrants (a quadrant is defined as a left buttock, right buttock, left posterolateral thigh or right posterolateral thigh) as assessed by the Investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at the Screening visit; has a score of 2 (mild), 3 (moderate) or 4 (severe) as reported by the Investigator (CR-PCSS) in 4 quadrants at the Screening visit.
. Have a body mass index (BMI) between 20.0 and 35.0 kg/m\^2, and intends to maintain stable body weight throughout the duration of the study (a variation of ≤10% from baseline body weight is permitted).
. Be willing to apply sunscreen to the dosing quadrants before each exposure to the sun while participating in the study (ie, screening through end of study).
. Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening.

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

Plasma AUX-I and AUX-II Concentrations

Timeframe: Day 1 to Day 22

Investigator CR-PCSS Rating

Timeframe: Day 1 to Day 22

Investigator CR-PCSS Change From Baseline

Timeframe: Day 1 to Day 22

Investigator CR-PCSS Responder Analysis at End of Study

Timeframe: Day 22

Trial details

NCT IDNCT03675685

SponsorEndo USA Inc., a Keenova Therapeutics Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-01

Results submitted2020-08-05

View on ClinicalTrials.gov More Edematous Fibrosclerotic Panniculopathy trials

Plain-language summary

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 a female ≥18 years of age.
. Have evidence of cellulite within 4 quadrants (a quadrant is defined as a left buttock, right buttock, left posterolateral thigh or right posterolateral thigh) as assessed by the Investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at the Screening visit; has a score of 2 (mild), 3 (moderate) or 4 (severe) as reported by the Investigator (CR-PCSS) in 4 quadrants at the Screening visit.
. Have a body mass index (BMI) between 20.0 and 35.0 kg/m\^2, and intends to maintain stable body weight throughout the duration of the study (a variation of ≤10% from baseline body weight is permitted).
. Be willing to apply sunscreen to the dosing quadrants before each exposure to the sun while participating in the study (ie, screening through end of study).
. Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening.

Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP

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