Collagenase clostridium histolyticum

Generic Name: Collagenase clostridium histolyticum

Brand Names: Qwo, Santyl, Xiaflex

Drug Type: Biotech

CAS Number: 9001-12-1

Unique Ingredient Identifier: 9X7O8V25IT

Background: Collagenase clostridium histolyticum is an enzyme produced by the bacterium Clostridium histolyticum. It is beneficial in the breakdown of collagen plaques for the treatment of Dupuytren's contracture and Peyronie's disease. The topical formulation is used for the debridement of necrotic tissue due to burns or chronic ulcers.

On July 6, 2020 a combination of injectable bacterial collagenases was approved by the FDA for the treatment of cellulite in adult women. Also known as Qwo, this injection is the first approved injectable treatment for cellulite and was developed by Endo International.

Indication: Collagenase clostridium histolyticum is indicated for the treatment of adults with Dupuytren's contracture with a palpable cord. Additionally, it is used to treat men with Peyronie's disease diagnosed with a penile curvature deformity of at least a 30-degree angle at the beginning of therapy in addition to palpable plaques. Collagenase ointment is used for the tissue debridement of chronic dermal ulcers and severely burned tissues.

The combination collagenase product, also known as Qwo, is used for the treatment of moderate to severe cellulite in the buttocks of adult women.

Associated Conditions: Dupuytren's Contracture of the Hand (Viking's Disease), Peyronie's Disease, Necrotic tissue

Clinical Trials

Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma

Phase 2

Completed

Conditions: Lipoma

Interventions: Drug: AA4500
Drug: placebo

First Posted Date: 2014-09-25

Last Posted Date: 2017-02-23

Lead Sponsor: Gerut, Zachary, M.D.

Target Recruit Count: 19

Registration Number: NCT02249052

Locations: 🇺🇸
Aesthetic Center, Hewlett, New York, United States
🇺🇸
Vanderbilt University, Nashville, Tennessee, United States

EZCast-DFU Study With Portal for Application of Topical Medications

Phase 1

Completed

Conditions: Foot Ulcer
Diabetic Foot

Interventions: Drug: Collagenase ointment
Device: Modified Contact Cast System

First Posted Date: 2014-05-06

Last Posted Date: 2015-06-10

Lead Sponsor: University of Miami

Target Recruit Count: 4

Registration Number: NCT02131961

Locations: 🇺🇸
University of Miami, University of Miami Hospital & Clinics, Miami, Florida, United States

Evaluate the Noninferiority of Medicines Treating Uninfected Pressure Ulcers.

Phase 3

Withdrawn

Conditions: Pressure Ulcer

Interventions: Drug: Kollagenase
Drug: Collagenase

First Posted Date: 2013-12-09

Last Posted Date: 2015-07-16

Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.

Registration Number: NCT02004626

Locations: 🇧🇷
Clínica Dr. Norton Sayeg Ltda, São Paulo, Brazil

A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma

Phase 2

Completed

Conditions: Lipoma

Interventions: Drug: Collagenase Clostridium Histolyticum

First Posted Date: 2012-06-07

Last Posted Date: 2016-10-06

Lead Sponsor: Zachary Gerut

Target Recruit Count: 14

Registration Number: NCT01613313

Locations: 🇺🇸
Zachary E. Gerut, M.D., Hewlett, New York, United States

Collagenase Option for Reduction of Dupuytren's Contracture in Japan

Phase 3

Completed

Conditions: Dupuytren's Contracture

Interventions: Drug: Collagenase Clostridium Histolyticum

First Posted Date: 2012-04-30

Last Posted Date: 2017-03-21

Lead Sponsor: Asahi Kasei Pharma Corporation

Target Recruit Count: 104

Registration Number: NCT01588353

Using Santyl or Bacitracin on Second Degree Burns

Phase 4

Withdrawn

Conditions: Burn, Partial Thickness

Interventions: Drug: Collagenase Santyl
Biological: Bacitracin

First Posted Date: 2012-01-24

Last Posted Date: 2012-05-16

Lead Sponsor: Healthpoint

Registration Number: NCT01516463

Injectable Collagenase For Burns' Associated Contracture

Phase 2

Conditions: Burn's Associated Contracture

Interventions: Drug: Xiaflex (FDA approved collagenase)

First Posted Date: 2010-11-10

Last Posted Date: 2010-11-10

Lead Sponsor: Sheba Medical Center

Target Recruit Count: 10

Registration Number: NCT01237964

Locations: 🇮🇱
Sheba Hospital, Ramat Gan, Israel

A Study to Look at the Effects of Four Weeks of Treatment on the Healing of Diabetic Foot Ulcers

Phase 4

Completed

Conditions: Diabetic Foot Ulcers

Interventions: Drug: Santyl
Other: White Petrolatum

First Posted Date: 2010-06-14

Last Posted Date: 2013-05-06

Lead Sponsor: Healthpoint

Target Recruit Count: 57

Registration Number: NCT01143714

Locations: 🇺🇸
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
🇺🇸
The Foot and Ankle Institute of Western Pennsylvania, Pittsburgh, Pennsylvania, United States
🇺🇸
Boston Medical Center, Boston, Massachusetts, United States

and more 3 locations

Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers

Phase 4

Completed

Conditions: Diabetic Foot Ulcers

Interventions: Drug: Tegaderm Hydrogel
Drug: Santyl

First Posted Date: 2010-06-14

Last Posted Date: 2013-05-31

Lead Sponsor: Healthpoint

Target Recruit Count: 20

Registration Number: NCT01143727

Locations: 🇺🇸
Richard C. Galperin, DPM, Dallas, Texas, United States

Santyl vs. Sharp Debridement of Diabetic Foot Wounds

Phase 4

Completed

Conditions: Diabetic Foot Ulcers
Foot Wounds

Interventions: Drug: Santyl
Procedure: Control

First Posted Date: 2010-01-26

Last Posted Date: 2012-11-21

Lead Sponsor: Healthpoint

Target Recruit Count: 48

Registration Number: NCT01056198

Locations: 🇺🇸
St. Elizabeth Regional Medical Center, Lincoln, Nebraska, United States
🇺🇸
UNTHSC Fort Worth, Fort Worth, Texas, United States
🇺🇸
Advanced Regional Center for Ankle and Foot Care, Altoona, Pennsylvania, United States

and more 6 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy