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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04580303
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:
This study is designed to investigate the safety and efficacy of CCH for the treatment of 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 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
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

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)




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 subjects participating in the collection of ultrasound data, the following exclusions will apply: subjects 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04580303


Contacts
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Contact: Erin Brown 800-462-3636 ClinicalTrials@Endo.com
Contact: Robert Yon 800-462-3636 ClinicalTrials@Endo.com

Locations
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United States, Louisiana
Endo Clinical Trial Site #2 Recruiting
Metairie, Louisiana, United States, 70006
United States, New York
Endo Clinical Trial Site #1 Recruiting
New York, New York, United States, 10021
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Karen Chajko Endo Pharmaceuticals
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04580303    
Other Study ID Numbers: EN3835-224
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cellulite
Skin Manifestations