Clinical trials: Edematous Fibrosclerotic Panniculopathy
Edematous Fibrosclerotic Panniculopathy, Cellulite
Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks
The study will evaluate the effect of different doses, strengths (concentrations), diluent additives, depths of injection, and methods of injection on the severity of bruising potentially induced by QWO (collagenase clostridium…
- Trial name
- APHRODITE (NCT05419505)
- Testing
- CCH-aaes, Antifibrinolytic Agent
- Where
- 13 sites in United States
- Volunteers
- 91 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
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, Cellulite
Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite)
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.
- Trial name
- NCT03526549
- Testing
- CCH-aaes, Observation
- Where
- 42 sites in United States
- Volunteers
- 483 people
- 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
Cellulite, Laxity; Skin
Durability and Safety of CCH With Two Different Injection Techniques in Cellulite With Laxity
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.
- Conditions
- Cellulite, Laxity; Skin, Edematous Fibrosclerotic Panniculopathy
- Trial name
- NCT05249257
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Edematous Fibrosclerotic Panniculopathy, Cellulite
CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques
This study is designed to investigate the safety and efficacy of collagenase clostridium histolyticum (CCH) for the treatment of mild to moderate edematous fibrosclerotic panniculopathy (cellulite) in participants with moderate…
- Conditions
- Edematous Fibrosclerotic Panniculopathy, Cellulite, Laxity; Skin
- Trial name
- NCT04580303
- Testing
- collagenase clostridium histolyticum
- Where
- 3 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- 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
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
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
Edematous Fibrosclerotic Panniculopathy, Cellulite
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).
- Trial name
- NCT02942160
- Testing
- Collagenase Clostridium Histolyticum
- Where
- 15 sites in United States
- Volunteers
- 259 people
- 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
Edematous Fibrosclerotic Panniculopathy (Cellulite)
Effectiveness and Safety of EN3835 in the Treatment of 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-2 (NCT03446781)
- Testing
- EN3835
- Where
- 25 sites in United States
- Volunteers
- 422 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, Cellulite
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
The study will evaluate the safety, effectiveness, and immunogenicity of EN3835 in the treatment of adult women with Edematous Fibrosclerotic Panniculopathy (Commonly known as Cellulite).
- Trial name
- NCT02724644
- Testing
- COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
- Where
- 16 sites in United States
- Volunteers
- 375 people, healthy volunteers welcome
- 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
Edematous Fibrosclerotic Panniculopathy, Cellulite
The Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
This study will evaluate the safety, effectiveness, pharmacokinetics, and immunogenicity of AA4500 at increasing doses and concentrations in the treatment of adult women with cellulite.
- Trial name
- NCT01518907
- Testing
- COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company