Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Women

Cellulite Clinical Trial

Official title:

A Phase 2a, Open Label Study to Assess the Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Females Using Photonumeric Scales, Magnetic Resonance Imaging and Histopathology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04209530
• Other study ID #: EN3835-212
• Status: Terminated
• Phase: Phase 2
• Start date: November 20, 2019
• Est. completion date: October 5, 2020

Study information

• Verified date: November 2020
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 Edematous Fibrosclerotic Panniculopathy (EFP).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 5, 2020
• Est. primary completion date: July 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Have both buttocks or both posterolateral thighs with:

1. A score of 3 or 4 (moderate or severe) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).

2. A Hexsel Cellulite Severity Scale (CSS) Subsection A "Number of Evident Depressions" score of >0, and Subsection B "Depth of Depressions" score of 2 )medium depth depression) or 3 (deep depressions)..

2. Have a minimum of 2 well defined and isolated cellulite dimples.

3. Be willing to apply sunscreen to the treatment area before each exposure to the sun for the duration of the study (from the Screening Visit through the Day 251/Early Termination Visit).

4. Be judged to be in good health.

5. Have a negative pregnancy test.

6. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

1. Is from a vulnerable population, as defined by the United States (US) Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).

2. Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.

3. Has systemic conditions (coagulation disorders, malignancy, keloidal scar, abnormal wound healing) that restricts study participation.

4. Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.

5. Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin.

6. Requires anticoagulant or antiplatelet medication during the study.

7. Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.

8. Has used any form of artificial tanning (sprays, lotions, tanning booth, etc) within the 30 days prior to the first dose of study treatment or plans to use any form of artificial tanning during the study (through the Day 251/Early Termination Visit).

9. Has a positive HIV test and/or a positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) test at screening.

10. Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment.

11. Has a history of keloids, hypertrophied scars, and/or other complications following biopsy.

12. Has any contraindications for MRI(implant containing metal, internal metallic object, permanent cosmetics/make-up, claustrophobia, syncope, low blood pressure, epilepsy, asthma, sickle cell disease) that restricts study participation.

13. Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH in a previous investigational study for cellulite.

14. Has previously received treatment with CCH in this clinical study.

15. Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit.

16. Is pregnant and/or is providing breast milk or plans to become pregnant and/or to provide breast milk during the course of the study.

17. Has any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.

Related Conditions & MeSH terms

• Cellulite
• Edematous Fibrosclerotic Panniculopathy (EFP)

Intervention

Drug:
• EN3835
Collagenase Clostridium Histolyticum (CCH)

Locations

Country	Name	City	State
United States	Endo Clinical Trial Site #1	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change From Baseline (Screening) in PR-PCSS	Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (None) to "4" (Severe) from a patient's perspective	Day 71
Secondary	The Change From Baseline (Screening) in CR-PCSS	Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (None) to "4" (Severe) from a clinician's perspective	Day 22, Day 43 and Day 71
Secondary	The Change From Baseline (Screening) in Hexsel Cellulite Severity Scale (CSS)	Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite, each feature is evaluated on a 4-point scale from "0" (Low) to "3" (High)	Day 22, Day 43 and Day 71
Secondary	MRI Before and After CCH Treatment	Magnetic Resonance Imaging (MRI) of cellulite before and after CCH treatment	Day 71
Secondary	Histopathology Before and After CCH Treatment	Histopathology of biopsies defined by the observation of the biopsied specimen by a trained Pathologist	Day 71