CompletedPhase 3

Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite)

United States483 participantsStarted 2018-04-26

Plain-language summary

A Phase 3b, Open-Label Extension Study to evaluate safety and how long response of EN3835 (Collagenase Clostridium Histolyticum \[CCH\]-aaes) lasts in the treatment of 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

. Voluntarily sign and date an informed consent agreement
. Have participated in and completed the double-blind Phase 3 study EN3835-302 or EN3835-303
. Be willing to apply sunscreen to the buttocks before each exposure to the sun and/or tanning booths while participating in the study
. Be judged to be in good health
. Be willing and able to cooperate with the requirements of the study
. Be able to read, complete and understand the participant reported outcomes rating instruments in English.

Exclusion criteria

. Intends to or has used any of the local applications/therapies/injections/procedures that restricts study participation
. Intends to use tanning spray or tanning booths during this period
. Has received or intends to receive an investigational drug or treatment, other than the treatment received in study EN3835-302/303 during this period
. Any other condition(s) that, in the Investigator's opinion, might indicate the participant to be unsuitable for the 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

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to Day 1080

Percentage of Participants Who Were Seropositive for Anti-Drug Antibodies (ADAs) After CCH-aaes Treatment

Timeframe: From Day 180 (Open-label Phase) up to Day 1080

Trial details

NCT IDNCT03526549

SponsorEndo USA Inc., a Keenova Therapeutics Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-08

Results submitted2022-10-07

View on ClinicalTrials.gov More Edematous Fibrosclerotic Panniculopathy trials