ClinicalTrials.gg
CompletedNCT04580303Updated Sep 28, 2022Results posted

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

A Phase 2 interventional study of collagenase clostridium histolyticum in Edematous Fibrosclerotic Panniculopathy, Cellulite and Laxity; Skin, sponsored by Endo Pharmaceuticals. Completed at 3 sites in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-28.

Sponsored by Endo Pharmaceuticals (part of Keenova Therapeutics plc) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Edematous Fibrosclerotic Panniculopathy
  • Cellulite
  • Laxity; Skin

Browse trials for

03

In context

Cellulite

71 studies on the registry are indexed under Cellulite; 3 are open to participants now.

This study's enrollment of 35 is close to the median of 34 across 65 interventional studies indexed under Cellulite.

Browse Cellulite studies →

Lead sponsor

Endo Pharmaceuticals is the lead sponsor of 99 studies on the registry; none are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.

First submitted before Endo Pharmaceuticals became part of Keenova Therapeutics plc.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Have a 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-
  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

Exclusion Criteria:

  1. Has a history of or allergy to collagenase or any other 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 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 abnormalities, as judged by the investigator, in any of the following: physical examination findings, (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 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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Active comparator
    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)

    Drug: collagenase clostridium histolyticum

  • Active comparator
    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)

    Drug: collagenase clostridium histolyticum

  • Active comparator
    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)

    Drug: collagenase clostridium histolyticum

  • Active comparator
    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)

    Drug: collagenase clostridium histolyticum

Interventions

06

What researchers measure

Primary outcomes

  1. Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh

    I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.

    Time frame: Day 180

Secondary outcomes

  1. Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh

    I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.

    Time frame: Days 28, 56, 84, 112, and 140

  2. Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh

    S-GAIS assessments were based on digital photographs, and were performed separately for each of 2 treatment areas. S-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the participant ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level S-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the S-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.

    Time frame: Days 28, 56, 84, 112, 140, and 180

  3. Change From Baseline in Body-Q Appraisal of Cellulite Total Score

    The Body-Q Appraisal of Cellulite is a subset of 11 questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. Total score is the sum of all 11 question scores. The minimum possible total score is 11 and the maximum possible total score is 44. Higher scores indicate the individual is less bothered by their cellulite.

    Time frame: Baseline, Day 180

  4. Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score

    Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite using a 4-point scale from a low of 0 to high of 3: 0 (absence of laxity, flaccidity, or sagging skin), 1 (slight draped appearance), 2 (moderate draped appearance), and 3 (severe draped appearance). The investigator or qualified designee used the Hexsel CSS Subsection D to assess the severity of dermal laxity in each buttock or each thigh independently. A decrease from baseline indicated a better outcome.

    Time frame: Baseline, Days 28, 56, 84, 112,140, and 180

  5. Percentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies

    Blood samples were collected to assess anti-clostridial class I collagenase (AUX-I) and anti-Clostridial class II collagenase (AUX-II) antibody levels. The percentage of participants who were positive for anti-AUX-I and anti-AUX-II antibodies are presented.

    Time frame: Day 180

  6. Percentage of Participants Positive for Neutralizing Antibodies to AUX-I and AUX-II

    Blood samples were collected to assess neutralizing antibodies to AUX-I and AUX-II. The percentage of participants who were positive for neutralizing antibodies to AUX-I and AUX-II are presented.

    Time frame: Day 180

07

Results

Posted Sep 28, 2022

Participant flow

Participant flow — Overall Study
MilestoneUniform 0.1-mL (Milliliter) 1-Aliquot Grid Injection Technique (Buttocks)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks)Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs)
Started79910
Completed78810
Not completed0110
Withdrew: Adverse event0100
Withdrew: Withdrawal by subject0010

Outcome measures

PrimaryPercentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh

I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.

Time frame:
Day 180
Reported as:
Number · percentage of participants
Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh
percentage of participantsUniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks)Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs)
Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh85.7 (42.13 to 99.64)87.5 (47.35 to 99.68)75.0 (34.91 to 96.81)80.0 (44.39 to 97.48)
SecondaryPercentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh

I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.

Time frame:
Days 28, 56, 84, 112, and 140
Reported as:
Number · percentage of participants
Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh
percentage of participantsUniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks)Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs)
Day 2871.4 (29.04 to 96.33)44.4 (13.70 to 78.80)77.8 (39.99 to 97.19)77.8 (39.99 to 97.19)
Day 5685.7 (42.13 to 99.64)62.5 (24.49 to 91.48)88.9 (51.75 to 99.72)88.9 (51.75 to 99.72)
Day 8457.1 (18.41 to 90.10)75.0 (34.91 to 96.81)77.8 (39.99 to 97.19)70.0 (34.75 to 93.33)
Day 11285.7 (42.13 to 99.64)50.0 (15.70 to 84.30)77.8 (39.99 to 97.19)80.0 (44.39 to 97.48)
Day 14071.4 (29.04 to 96.33)75.0 (34.91 to 96.81)75.0 (34.91 to 96.81)80.0 (44.39 to 97.48)
SecondaryPercentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh

S-GAIS assessments were based on digital photographs, and were performed separately for each of 2 treatment areas. S-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the participant ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level S-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the S-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.

Time frame:
Days 28, 56, 84, 112, 140, and 180
Reported as:
Number · percentage of participants
Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh
percentage of participantsUniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks)Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs)
Day 2871.4 (29.04 to 96.33)44.4 (13.70 to 78.80)66.7 (29.93 to 92.51)66.7 (29.93 to 92.51)
Day 5685.7 (42.13 to 99.64)75.0 (34.91 to 96.81)88.9 (51.75 to 99.72)88.9 (51.75 to 99.72)
Day 8471.4 (29.04 to 96.33)87.5 (47.35 to 99.68)55.6 (21.20 to 86.30)70.0 (34.75 to 93.33)
Day 11285.7 (42.13 to 99.64)62.5 (24.49 to 91.48)55.6 (21.20 to 86.30)70.0 (34.75 to 93.33)
Day 14071.4 (29.04 to 96.33)87.5 (47.35 to 99.68)62.5 (24.49 to 91.48)70.0 (34.75 to 93.33)
Day 18085.7 (42.13 to 99.64)100.0 (NA to NA)62.5 (24.49 to 91.48)90.0 (55.50 to 99.75)
SecondaryChange From Baseline in Body-Q Appraisal of Cellulite Total Score

The Body-Q Appraisal of Cellulite is a subset of 11 questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. Total score is the sum of all 11 question scores. The minimum possible total score is 11 and the maximum possible total score is 44. Higher scores indicate the individual is less bothered by their cellulite.

Time frame:
Baseline, Day 180
Reported as:
Mean · units on a scale
Change From Baseline in Body-Q Appraisal of Cellulite Total Score
units on a scaleUniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks)Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs)
Change From Baseline in Body-Q Appraisal of Cellulite Total Score13.4 ± 11.1213.6 ± 9.9410.0 ± 5.816.4 ± 10.56
SecondaryChange From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score

Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite using a 4-point scale from a low of 0 to high of 3: 0 (absence of laxity, flaccidity, or sagging skin), 1 (slight draped appearance), 2 (moderate draped appearance), and 3 (severe draped appearance). The investigator or qualified designee used the Hexsel CSS Subsection D to assess the severity of dermal laxity in each buttock or each thigh independently. A decrease from baseline indicated a better outcome.

Time frame:
Baseline, Days 28, 56, 84, 112,140, and 180
Reported as:
Mean · units on a scale
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score
units on a scaleUniform 0.1-mL 1-Aliqout Grid Injection Technique (Buttocks)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks)Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs)
Day 28 Left Treatment Area0.0 ± 0.000.0 ± 0.000.0 ± 0.000.0 ± 0.00
Day 28 Right Treatment Area0.0 ± 0.000.0 ± 0.000.0 ± 0.000.0 ± 0.00
Day 56 Left Treatment Area0.0 ± 0.000.0 ± 0.000.0 ± 0.000.0 ± 0.00
Day 56 Right Treatment Area0.0 ± 0.000.0 ± 0.000.0 ± 0.000.0 ± 0.00
Day 84 Left Treatment Area-0.1 ± 0.380.0 ± 0.000.0 ± 0.000.0 ± 0.00
Day 84 Right Treatment Area-0.1 ± 0.380.0 ± 0.000.0 ± 0.000.0 ± 0.00
Day 112 Left Treatment Area-0.1 ± 0.380.0 ± 0.000.0 ± 0.000.0 ± 0.00
Day 112 Right Treatment Area-0.1 ± 0.380.0 ± 0.000.0 ± 0.000.0 ± 0.00
Day 140 Left Treatment Area-0.4 ± 0.53-0.1 ± 0.350.0 ± 0.00-0.2 ± 0.42
Day 140 Right Treatment Area-0.3 ± 0.49-0.1 ± 0.35-0.1 ± 0.35-0.2 ± 0.42
Day 180 Left Treatment Area-0.3 ± 0.49-0.1 ± 0.64-0.1 ± 0.35-0.6 ± 0.52
Day 180 Right Treatment Area-0.3 ± 0.49-0.1 ± 0.64-0.1 ± 0.35-0.5 ± 0.53
SecondaryPercentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies

Blood samples were collected to assess anti-clostridial class I collagenase (AUX-I) and anti-Clostridial class II collagenase (AUX-II) antibody levels. The percentage of participants who were positive for anti-AUX-I and anti-AUX-II antibodies are presented.

Time frame:
Day 180
Reported as:
Number · percentage of participants
Percentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies
percentage of participantsCCH: Overall Participants
Anti-AUX-I Antibodies100
Anti-AUX-II Antibodies100
SecondaryPercentage of Participants Positive for Neutralizing Antibodies to AUX-I and AUX-II

Blood samples were collected to assess neutralizing antibodies to AUX-I and AUX-II. The percentage of participants who were positive for neutralizing antibodies to AUX-I and AUX-II are presented.

Time frame:
Day 180
Reported as:
Number · percentage of participants
Percentage of Participants Positive for Neutralizing Antibodies to AUX-I and AUX-II
percentage of participantsCCH: Overall Participants
Neutralizing antibodies to AUX-I87.5
Neutralizing antibodies to AUX-II84.4

Adverse events

Collected over Day 1 (after dosing) through Day 180. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks or Thighs)0/16 (0%)0/16 (0%)16/16 (100%)
Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks or Thighs)0/19 (0%)0/19 (0%)19/19 (100%)
Most frequent other events
Showing 10 of 17
Most frequent other events
EventUniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks or Thighs)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks or Thighs)
Injection site bruisingGeneral disorders16/1619/19
Injection site painGeneral disorders10/1613/19
Injection site swellingGeneral disorders10/1610/19
Injection site pruritusGeneral disorders2/162/19
Injection site discolourationGeneral disorders1/161/19
Injection site urticariaGeneral disorders1/160/19
Ear infectionInfections and infestations1/160/19
AlcoholismPsychiatric disorders1/160/19
FatigueGeneral disorders0/161/19
Implant site inflammationGeneral disorders0/161/19

Baseline characteristics

Safety Population: All enrolled participants who received at least 1 injection of CCH. Participants who received injection in the buttock or thigh are combined for each injection technique.

Age, Continuous
Age, Continuous(years)Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttock or Thigh)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttock or Thigh)Total
Mean40.73 ± 8.84442.51 ± 6.22541.70 ± 7.472
Sex: Female, Male
Sex: Female, Male(Participants)Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttock or Thigh)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttock or Thigh)Total
Female161935
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttock or Thigh)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttock or Thigh)Total
Hispanic or Latino044
Not Hispanic or Latino161531
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttock or Thigh)Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttock or Thigh)Total
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American213
White131831
More than one race000
Unknown or Not Reported000
08

Study locations

3 sites
  • Endo Clinical Trial Site #3
    Coral Gables, Florida 33146, United States
  • Endo Clinical Trial Site #2
    Metairie, Louisiana 70006, United States
  • Endo Clinical Trial Site #1
    New York, New York 10021, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04580303
Responsible party
Sponsor
First posted
Oct 8, 2020
Start date
Oct 1, 2020
Primary completion
Aug 30, 2021
Completion
Sep 24, 2021
Results posted
Sep 28, 2022
Last update
Sep 28, 2022

Study contacts

David Hernandez
study director · Endo Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Microbial Collagenase

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