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

• ClinicalTrials.gov Identifier: NCT04580303
• Recruitment Status: Completed
• First Posted: October 8, 2020
• Last Update Posted: November 19, 2021
• Sponsor: Endo Pharmaceuticals
• Information provided by (Responsible Party): Endo Pharmaceuticals

Study Description

Brief Summary:

This study is designed to investigate the safety and efficacy of CCH for the treatment of mild to moderate edematous fibrosclerotic panniculopathy (cellulite) in participants with moderate to severe dermal laxity in buttocks and thighs with comparison between two (2) different CCH injection techniques.

Condition or disease	Intervention/treatment	Phase
Edematous Fibrosclerotic Panniculopathy; Cellulite; Laxity; Skin	Drug: EN3835	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Multicenter, Open-label, Randomized, Parallel-group, Multiple-dose Study to Assess the Effectiveness, Safety and Satisfaction With Collagenase Clostridium Histolyticum Grid Technique Injections of Buttock or Thigh Cellulite With Laxity in Adult Females
• Actual Study Start Date: October 1, 2020
• Actual Primary Completion Date: August 30, 2021
• Actual Study Completion Date: September 24, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Uniform 0.1-mL 1-Aliqout GRID Injection Technique; Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area)	Drug: EN3835; collagenase clostridium histolyticum (CCH)
Active Comparator: Uniform 0.3-mL 2-Aliquot GRID Injection Technique; Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area)	Drug: EN3835; collagenase clostridium histolyticum (CCH)

Outcome Measures

Primary Outcome Measures :

1. Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh [ Time Frame: Day 180 ]
   Investigator-Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to "-3" (very much worse) to determine the degree of improvement of the treated areas

Secondary Outcome Measures :

1. Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh [ Time Frame: Day 28, 56, 84, 112, and 140 ]
   Investigator-Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to "-3" (very much worse) to determine the degree of improvement of the treated areas
2. I-GAIS ratings [ Time Frame: Days 28, 56, 84, 112, 140, and 180 ]
   Investigator-Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to "-3" (very much worse) to determine the degree of improvement of the treated areas
3. Proportion of I-level responders (+ 1 or better score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for either buttock or either thigh [ Time Frame: Day 28, 56, 84, 112, 140, and 180 ]
   The S-GAIS is a 7-level scale ranging from 3 (very much improved) to -3 (very much worse).
4. Change from Baseline in the Body-Q Appraisal of the individual item cellulite scores and total score [ Time Frame: Change from baseline to Day 180 ]
   Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire that was developed to measure patient perceptions of weight loss and/or body contouring
5. Change from baseline to each study visit in Hexsel CSS Subsection D severity score [ Time Frame: Day 28 through Day 180 ]
   Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite using a 4-point scale from a low of O to a high of 3
6. Anti-AUX-I and Anti-AUX-II antibody levels [ Time Frame: Day 1 and 180 ]
   Anti- Clostridial class I collagenase (AUX-I) and Anti- Clostridial class II collagenase (AUX-II) antibody levels
7. Neutralizing antibodies to AUX-I and AUX-II [ Time Frame: Day 1 and 180 ]
   Neutralizing antibodies to AUX-I and AUX-II

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Have a BMI of 18 to < 29.9 kg/m2.

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

   1. A score of 2 or 3 (mild or moderate cellulite) as reported by the investigator using the CR-PCSS, and
   2. a Hexsel 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. At the Screening Visit 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 subject 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 ECGs indicating corrected QT interval (QTc) prolongation of 470 ms 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 (e.g., 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.

Contacts and Locations

Locations

United States, Florida

Endo Clinical Trial Site #3

Coral Gables, Florida, United States, 33146

United States, Louisiana

Endo Clinical Trial Site #2

Metairie, Louisiana, United States, 70006

United States, New York

Endo Clinical Trial Site #1

New York, New York, United States, 10021

Sponsors and Collaborators

Endo Pharmaceuticals

Investigators

• Study Director: Karen Chajko; Endo Pharmaceuticals

More Information

• Responsible Party: Endo Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04580303
• Other Study ID Numbers: EN3835-224
• First Posted: October 8, 2020
• Last Update Posted: November 19, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cellulite; Skin Manifestations