20 completed, 3 active not recruiting, 2 unknown, 2 withdrawn. 9 Phase 2, 8 Phase 4, 7 Phase 3, 2 Not applicable, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 8, Withdrawn 1 |
| Phase 4 | 8 | Completed 4, Active not recruiting 3, Unknown 1 |
| Phase 3 | 7 | Completed 7 |
| Not applicable | 2 | Recruiting 1, Withdrawn 1 |
| Phase 1 | 1 | Completed 1 |
Follow XIAFLEX: new trials by email Literature Review of XIAFLEX trials Research Report on XIAFLEX
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease Collagenase Clostridium Histolyticum, RestoreX, Sildenafil - Peyronie Disease | Phase 4 | Active not recruiting | Charitable Union for the Research and Education of Peyronie's Disease | 40 | 2024-10-11 | 2026-08-26 |
| Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease Collagenase Clostridium Histolyticum, Storz Duolith LiSWT - Peyronie Disease, Erectile Dysfunction | Not applicable | Recruiting | Mayo Clinic | 60 | 2024-01-19 | 2026-10-16 |
| Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease Collagenase Clostridium Histolyticum (CCH) - Peyronie Disease, Sexual Dysfunctions, Psychological | Phase 4 | Active not recruiting | University of Miami | 12 | 2023-10-02 | 2026-06-04 |
| Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction Collagenase Clostridium Histolyticum, Duolith SD1 T-TOP - Peyronie Disease, Penile Curvature | Not applicable | Withdrawn | Mayo Clinic | 2023-03-01 | 2023-10-10 | |
| Effectiveness of Splinting After Collagenase Injection Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex], Xiaflex + Hand-Based Custom Orthosis - Dupuytren Contracture, Dupuytren's Disease | Phase 3 | Completed | Foundation for Orthopaedic Research and Education | 80 | 2021-07-12 | 2025-02-26 |
| Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH), Penile Plication Surgery, Incision and Grafting (I&G) Surgery - Peyronie's Disease | Phase 4 | Active not recruiting | Charitable Union for the Research and Education of Peyronie's Disease | 40 | 2020-12-30 | 2026-08-26 |
| Safety and Effectiveness of EN3835 in the Treatment of EFP in Women Collagenase Clostridium Histolyticum - Edematous Fibrosclerotic Panniculopathy, Cellulite | Phase 2 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 158 | 2017-11-17 | 2020-12-29 |
| EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) Collagenase Clostridium Histolyticum - Edematous Fibrosclerotic Panniculopathy, Cellulite | Phase 2 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 259 | 2016-10-05 | 2020-11-24 |
| EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) COLLAGENASE CLOSTRIDIUM HISTOLYTICUM, Placebo Comparator - Edematous Fibrosclerotic Panniculopathy, Cellulite | Phase 2 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 375 | 2016-02-01 | 2017-11-06 |
| Collagenase Injection vs Percutaneous Needle Aponeurotomy for Dupuytren's Disease Percutaneous Needle Aponeurotomy, XIAFLEX - Dupuytren Contracture, Dupuytren's Disease of Finger | Phase 4 | Unknown | University of Calgary | 334 | 2016-01-01 | 2016-12-21 |
| An Open-label Study to Assess the Safety and Effectiveness of AA4500 in Combination With the ErecAid® Esteem® Manual Vacuum Therapy System in Treating Men With Peyronie's Disease AA4500, ErecAid® Esteem® Manual Vacuum Therapy System, Investigator Modeling - Peyronie's Disease | Phase 3 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 30 | 2014-10-01 | 2017-11-08 |
| Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules Collagenase clostridium histolyticum, Placebo - Dupuytren's Disease | Phase 2 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 76 | 2014-07-01 | 2017-10-05 |
| Short-term Function and Pain After Treatment for Dupuytren's Disease Percutaneous Needle Aponeurotomy, Collagenase clostridium histolyticum - Dupuytren Disease | Unknown | Sunnybrook Health Sciences Centre | 60 | 2014-07-01 | 2016-12-06 | |
| Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder Collagenase Clostridium Histolyticum, Placebo - Adhesive Capsulitis, Frozen Shoulder | Phase 2 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 322 | 2013-11-01 | 2017-10-05 |
| Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF Xiapex, Needle aponeurotomy - Dupuytren Contracture | Phase 4 | Completed | University Hospital, Akershus | 80 | 2013-10-01 | 2022-04-26 |
| A Phase 2, Randomized, Double-blind, Placebo Controlled Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy Collagenase Clostridium Histolyticum, Placebo - Edematous Fibrosclerotic Panniculopathy (EFP) | Phase 2 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 150 | 2013-10-01 | 2017-10-05 |
| A Phase 3, Open-label Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease AA4500 - Peyronie's Disease | Phase 3 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 189 | 2012-09-01 | 2017-10-05 |
| A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma Collagenase Clostridium Histolyticum - Lipoma | Phase 2 | Completed | Zachary Gerut | 14 | 2012-05-01 | 2016-10-06 |
| Retreatment of Recurrent Dupuytren's Contractures Collagenase clostridium histolyticum - Dupuytren's Disease | Phase 4 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 52 | 2012-03-01 | 2017-10-05 |
| The Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) COLLAGENASE CLOSTRIDIUM HISTOLYTICUM - Edematous Fibrosclerotic Panniculopathy, Cellulite | Phase 1 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 99 | 2012-01-01 | 2015-03-19 |
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Penile Induration (10) · Dupuytren Contracture (9) · Cellulite (5) · Bursitis (3) · Erectile Dysfunction (2) · Contracture (1) · Genital Diseases, Male (1) · Lipoma (1) · Sexual Dysfunctions, Psychological (1) · Shoulder Pain (1) · Surgical Wound (1)
Endo USA Inc., a Keenova Therapeutics Company (15) · Charitable Union for the Research and Education of Peyronie's Disease (2) · Mayo Clinic (2) · Foundation for Orthopaedic Research and Education (1) · Hospital for Special Surgery, New York (1) · Indiana Hand to Shoulder Center (1) · Stony Brook University (1) · Sunnybrook Health Sciences Centre (1) · University Hospital, Akershus (1) · University of Calgary (1) · University of Miami (1) · Zachary Gerut (1)
United States (23) · Australia (6) · United Kingdom (3) · Canada (2) · Sweden (2) · Denmark (1) · France (1) · Germany (1) · Italy (1) · New Zealand (1) · Norway (1) · Spain (1)
Veronica Urdaneta, MD MPH (3) · Gregory J. Kaufman, MD (2) · Gregory Kaufman, MD (2) · Veronica Urdaneta, MD, MPPH (2) · Jason Nydick, DO (1) · Justin Yeung, MD (1) · Landon Trost, MD (1) · Marie A Badalamente, PhD (1) · Mike McLane (1) · Mike McLane, PhD (1) · Neil H Schusterman, MD FACP (1) · Neil H Shusterman, MD FACP (1) · Neil Shusterman, MD (1) · Per-Henrik Randsborg, PhD (1) · Scott W Wolfe, MD (1)