CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques

NCT ID: NCT04580303

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-09-24

Brief Summary

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 to severe dermal laxity in the buttocks or thighs with comparison between two (2) different CCH injection techniques.

Conditions

Edematous Fibrosclerotic Panniculopathy; Cellulite; Laxity; Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Uniform 0.1-milliliters (mL) 1-Aliquot Grid Injection Technique (Buttock)

Dose per participant per treatment visit = up to 1.68 milligrams (mg) of CCH (0.84 mg in each treatment area)

Group Type: ACTIVE_COMPARATOR

collagenase clostridium histolyticum

Intervention Type: DRUG

Delivered via uniform grid injection techniques.

Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttock)

Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area)

Group Type: ACTIVE_COMPARATOR

collagenase clostridium histolyticum

Intervention Type: DRUG

Delivered via uniform grid injection techniques.

Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thigh)

Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area)

Group Type: ACTIVE_COMPARATOR

collagenase clostridium histolyticum

Intervention Type: DRUG

Delivered via uniform grid injection techniques.

Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thigh)

Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area)

Group Type: ACTIVE_COMPARATOR

collagenase clostridium histolyticum

Intervention Type: DRUG

Delivered via uniform grid injection techniques.

Interventions

collagenase clostridium histolyticum

Delivered via uniform grid injection techniques.

Intervention Type: DRUG

Other Intervention Names

EN3835; CCH

Eligibility Criteria

Inclusion Criteria

1. Have a body mass index of 18 to <29.9 kilograms/square meters

2. Have either both buttocks or both posterolateral thighs with:

1. Score of 2 or 3 (mild or moderate cellulite) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS)

2. Hexsel Cellulite Severity Scale (CSS) Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of 2 or 3 (moderate or severe) as determined by the investigator

3. Have a negative pregnancy test or be of non-childbearing potential

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

5. Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study (from the Screening Visit through the Day 180/Early Termination Visit).

Exclusion Criteria

1. Has a history of hypersensitivity or allergy to collagenase or any other excipients of CCH.

2. During Screening has a CR-PCSS score of less than 2 or greater than 3 for the area to be treated (buttocks or thighs) and/or has a Hexsel CSS Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of less than 2 or greater than 3 (severe) for the areas to be treated (buttocks or thighs).

3. Has a coagulation disorder, which requires anticoagulant or antiplatelet medication during the study (except for ≤150 mg aspirin daily), or has taken anticoagulant or antiplatelet medication(s) within 14 days before injection of study treatment (except for ≤150 mg aspirin daily).

4. Is a prisoner, an individual with impaired decision making capacity, 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), or in the judgment of the investigator the participant is disadvantaged and vulnerable to coercion due to lack of education, or due to poor economic circumstances.

5. 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.

6. Is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study.

7. Has a history of scarring due to keloids or abnormal wound healing.

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

9. Has history of drug or alcohol abuse within the 5 years prior to the Screening Visit.

10. Has evidence of clinically significant abnormalities, as judged by the investigator, in any of the following: physical examination findings, electrocardiogram (ECG), clinical laboratory values, or vital signs.

The sponsor's medical monitor will be required to review the results for confirmation of eligibility in the case of any of the following: abnormalities in electrocardiograms indicating corrected QT interval (QTc) prolongation of 470 milliseconds or greater; and clinical laboratory values of liver enzymes

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

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

13. For the subset of participants participating in the collection of ultrasound data, the following exclusions will apply: participants will be excluded who have: a history of a spinal laminectomy, a previous history or presence of vascular abnormalities (for example, deep vein thrombosis, thrombophlebitis), a healing fracture, an impaired sensation within, or near, the planned treatment area, or any implants within, or near, the planned treatment area.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Hernandez

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Locations

Endo Clinical Trial Site #3

Coral Gables, Florida, United States

Endo Clinical Trial Site #2

Metairie, Louisiana, United States

Endo Clinical Trial Site #1

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

EN3835-224

Identifier Type: -

Identifier Source: org_study_id