Clinical trials: Edematous Fibrosclerotic Panniculopathy (EFP)
Cellulite
A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 1)
The Stage 1 of this phase 2 study is an open-label single ascending dose (SAD) study to assess the efficacy and safety of CBL-514 in participants with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite.
- Trial name
- NCT05632926
- Testing
- 40 mg CBL-514, 60 mg CBL-514, 80 mg CBL-514
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Caliway Biopharmaceuticals Co., Ltd.
Edematous Skin
Injection Techniques of Collagenase Clostridium Histolyticum (CCH) for the Treatment of EFP (Cellulite)
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…
- Trial name
- NCT03632993
- Testing
- collagenase clostridium histolyticum (CCH)
- Where
- 5 sites in United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Edematous Fibrosclerotic Panniculopathy (EFP), Cellulite
Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite
This study will investigate treatments that may mitigate bruising after QWO™ (Collagenase clostridium histolyticum [CCH]-aaes) treatment of cellulite in the buttocks.
- Trial name
- MOBI (NCT04677712)
- Testing
- CCH-aaes, Compression, Cold Packs
- Where
- 8 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Edematous Fibrosclerotic Panniculopathy
Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP
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).
- Trial name
- NCT03675685
- Testing
- CCH (collagenase clostridium histolyticum)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Edematous Fibrosclerotic Panniculopathy
Durability and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women
This is a Phase 2b, rollover, long-term study to evaluate the safety and duration of efficacy of EN3835 in the treatment of women with EFP.
- Trial name
- NCT03893890
- Testing
- Previously Treated with EN3835
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Edematous Fibrosclerotic Panniculopathy (EFP)
A Phase 2, Randomized, Double-blind, Placebo Controlled Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy
To assess the safety and effectiveness of repeat doses of AA4500 in the treatment of edematous fibrosclerotic panniculopathy (EFP) commonly known as cellulite in adult women.
- Trial name
- NCT01987986
- Testing
- Collagenase Clostridium Histolyticum
- Where
- 10 sites in United States
- Volunteers
- 150 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Cellulite
A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 2)
The Stage 2 of this phase 2 study is an open-label, single-arm study to assess the efficacy and safety of CBL-514 in participants with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite.
- Trial name
- NCT05836779
- Testing
- CBL-514 injection
- Where
- 5 sites in United States
- Volunteers
- 23 people
- Sponsor
- Caliway Biopharmaceuticals Co., Ltd.
Edematous Fibrosclerotic Panniculopathy
Long-term Durability Study of Collagenase Clostridium Histolyticum (CCH)
This study will evaluate the long-term safety and duration of efficacy of CCH in the treatment of women with cellulite. This study will be a single day evaluation, approximately 48 months after the first dose of study drug was…
- Trial name
- NCT04381117
- Testing
- Previously Treated with EN3835
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Edematous Fibrosclerotic Panniculopathy (EFP), Cellulite
Real World CCH Study in Adult Females With Cellulite
This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP).
- Trial name
- NCT04170296
- Testing
- EN3835
- Where
- 12 sites in United States, Puerto Rico
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Edematous Fibrosclerotic Panniculopathy, Cellulite
Safety and Effectiveness of EN3835 in the Treatment of EFP in Women
An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women.
- Trial name
- NCT03329989
- Testing
- Collagenase Clostridium Histolyticum
- Where
- 11 sites in United States
- Volunteers
- 158 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Cellulite, Edematous Fibrosclerotic Panniculopathy (EFP)
Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Women
This is a single center, open-label, Phase 2a study to assess the photonumeric scale, morphological, and histopathological changes associated with Collagenase Clostridium Histolyticum (CCH) in adult women with moderate or severe…
- Trial name
- NCT04209530
- Testing
- EN3835
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Edematous Fibrosclerotic Panniculopathy (Cellulite)
Effectiveness and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women
Subjects will be screened for study eligibility within 14 days prior to enrolling in this study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of cellulite as independently assessed by the…
- Trial name
- RELEASE-1 (NCT03428750)
- Testing
- EN3835
- Where
- 26 sites in United States
- Volunteers
- 423 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company