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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04580303
Recruitment Status : Completed
First Posted : October 8, 2020
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 2, 2020
First Posted Date  ICMJE October 8, 2020
Last Update Posted Date November 19, 2021
Actual Study Start Date  ICMJE October 1, 2020
Actual Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2021)
  • 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
  • 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
  • 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).
  • 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
  • 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
  • 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
  • Neutralizing antibodies to AUX-I and AUX-II [ Time Frame: Day 1 and 180 ]
    Neutralizing antibodies to AUX-I and AUX-II
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Edematous Fibrosclerotic Panniculopathy
  • Cellulite
  • Laxity; Skin
Intervention  ICMJE Drug: EN3835
collagenase clostridium histolyticum (CCH)
Study Arms  ICMJE
  • 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)
    Intervention: Drug: EN3835
  • 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)
    Intervention: Drug: EN3835
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2021)
35
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2020)
32
Actual Study Completion Date  ICMJE September 24, 2021
Actual Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04580303
Other Study ID Numbers  ICMJE EN3835-224
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Responsible Party Endo Pharmaceuticals
Study Sponsor  ICMJE Endo Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Karen Chajko Endo Pharmaceuticals
PRS Account Endo Pharmaceuticals
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP