Trial Outcomes & Findings for CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques (NCT NCT04580303)

Last Updated: 2022-09-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Day 180

Results posted on

2022-09-28

Participant Flow

Participants were randomized to receive treatment in either a uniform 0.1-milliliter (mL), 1-aliquot, grid injection technique or uniform 0.3-mL, 2-aliquot grid injection technique in a 1:1 ratio. Each participant had 2 treatment areas (each buttock or each thigh).

Unit of analysis: buttock or thigh

Participant milestones

Participant milestones
Measure	Uniform 0.1-mL (Milliliter) 1-Aliquot Grid Injection Technique (Buttocks) Dose per participant per treatment visit = up to 1.68 milligrams (mg) of collagenase clostridium histolyticum (CCH) (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).
Overall Study STARTED	7 14	9 18	9 18	10 20
Overall Study COMPLETED	7 14	8 16	8 16	10 20
Overall Study NOT COMPLETED	0 0	1 2	1 2	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Uniform 0.1-mL (Milliliter) 1-Aliquot Grid Injection Technique (Buttocks) Dose per participant per treatment visit = up to 1.68 milligrams (mg) of collagenase clostridium histolyticum (CCH) (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).
Overall Study Adverse Event	0	1	0	0
Overall Study Withdrawal by Subject	0	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttock or Thigh) n=16 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttock or Thigh) n=19 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Total n=35 Participants Total of all reporting groups
Age, Continuous	40.73 years STANDARD_DEVIATION 8.844 • n=5 Participants	42.51 years STANDARD_DEVIATION 6.225 • n=7 Participants	41.70 years STANDARD_DEVIATION 7.472 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 180

Population: Modified Intent-to-Treat (mITT) Population: All enrolled participants who received at least 1 injection of CCH and who had at least 1 valid I-GAIS evaluation after the injection of CCH.

Outcome measures

Outcome measures
Measure	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) n=7 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) n=8 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) n=8 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) n=10 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).
Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh	85.7 percentage of participants Interval 42.13 to 99.64	87.5 percentage of participants Interval 47.35 to 99.68	75.0 percentage of participants Interval 34.91 to 96.81	80.0 percentage of participants Interval 44.39 to 97.48

SECONDARY outcome

Timeframe: Days 28, 56, 84, 112, and 140

Population: mITT Population: All enrolled participants who received at least 1 injection of CCH and who had at least 1 valid I-GAIS evaluation after the injection of CCH.

Outcome measures

Outcome measures
Measure	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) n=7 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) n=9 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) n=9 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) n=10 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).
Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh Day 140	71.4 percentage of participants Interval 29.04 to 96.33	75.0 percentage of participants Interval 34.91 to 96.81	75.0 percentage of participants Interval 34.91 to 96.81	80.0 percentage of participants Interval 44.39 to 97.48
Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh Day 28	71.4 percentage of participants Interval 29.04 to 96.33	44.4 percentage of participants Interval 13.7 to 78.8	77.8 percentage of participants Interval 39.99 to 97.19	77.8 percentage of participants Interval 39.99 to 97.19
Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh Day 56	85.7 percentage of participants Interval 42.13 to 99.64	62.5 percentage of participants Interval 24.49 to 91.48	88.9 percentage of participants Interval 51.75 to 99.72	88.9 percentage of participants Interval 51.75 to 99.72
Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh Day 84	57.1 percentage of participants Interval 18.41 to 90.1	75.0 percentage of participants Interval 34.91 to 96.81	77.8 percentage of participants Interval 39.99 to 97.19	70.0 percentage of participants Interval 34.75 to 93.33
Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh Day 112	85.7 percentage of participants Interval 42.13 to 99.64	50.0 percentage of participants Interval 15.7 to 84.3	77.8 percentage of participants Interval 39.99 to 97.19	80.0 percentage of participants Interval 44.39 to 97.48

SECONDARY outcome

Timeframe: Days 28, 56, 84, 112, 140, and 180

Population: mITT Population: All enrolled participants who received at least 1 injection of CCH and who had at least 1 valid S-GAIS evaluation after the injection of CCH.

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.

Outcome measures

Outcome measures
Measure	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) n=7 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) n=9 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) n=9 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) n=10 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).
Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh Day 28	71.4 percentage of participants Interval 29.04 to 96.33	44.4 percentage of participants Interval 13.7 to 78.8	66.7 percentage of participants Interval 29.93 to 92.51	66.7 percentage of participants Interval 29.93 to 92.51
Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh Day 56	85.7 percentage of participants Interval 42.13 to 99.64	75.0 percentage of participants Interval 34.91 to 96.81	88.9 percentage of participants Interval 51.75 to 99.72	88.9 percentage of participants Interval 51.75 to 99.72
Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh Day 84	71.4 percentage of participants Interval 29.04 to 96.33	87.5 percentage of participants Interval 47.35 to 99.68	55.6 percentage of participants Interval 21.2 to 86.3	70.0 percentage of participants Interval 34.75 to 93.33
Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh Day 112	85.7 percentage of participants Interval 42.13 to 99.64	62.5 percentage of participants Interval 24.49 to 91.48	55.6 percentage of participants Interval 21.2 to 86.3	70.0 percentage of participants Interval 34.75 to 93.33
Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh Day 140	71.4 percentage of participants Interval 29.04 to 96.33	87.5 percentage of participants Interval 47.35 to 99.68	62.5 percentage of participants Interval 24.49 to 91.48	70.0 percentage of participants Interval 34.75 to 93.33
Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh Day 180	85.7 percentage of participants Interval 42.13 to 99.64	100.0 percentage of participants Confidence interval was not calculated for dispersion since all participants were responders.	62.5 percentage of participants Interval 24.49 to 91.48	90.0 percentage of participants Interval 55.5 to 99.75

SECONDARY outcome

Timeframe: Baseline, Day 180

Population: mITT Population: All enrolled participants who received at least 1 injection of CCH and who had an assessment as the specified timepoint.

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.

Outcome measures

Outcome measures
Measure	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) n=7 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) n=8 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) n=8 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) n=10 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).
Change From Baseline in Body-Q Appraisal of Cellulite Total Score	13.4 units on a scale Standard Deviation 11.12	13.6 units on a scale Standard Deviation 9.94	10.0 units on a scale Standard Deviation 5.81	6.4 units on a scale Standard Deviation 10.56

SECONDARY outcome

Timeframe: Baseline, Days 28, 56, 84, 112,140, and 180

Population: mITT Population: All enrolled participants who received at least 1 injection of CCH and who had an assessment as the specified timepoint.

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.

Outcome measures

Outcome measures
Measure	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) n=7 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) n=9 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) n=9 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) n=10 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score Day 28 Left Treatment Area	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score Day 28 Right Treatment Area	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score Day 56 Right Treatment Area	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score Day 84 Right Treatment Area	-0.1 units on a scale Standard Deviation 0.38	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score Day 56 Left Treatment Area	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score Day 84 Left Treatment Area	-0.1 units on a scale Standard Deviation 0.38	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score Day 112 Left Treatment Area	-0.1 units on a scale Standard Deviation 0.38	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score Day 112 Right Treatment Area	-0.1 units on a scale Standard Deviation 0.38	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score Day 140 Left Treatment Area	-0.4 units on a scale Standard Deviation 0.53	-0.1 units on a scale Standard Deviation 0.35	0.0 units on a scale Standard Deviation 0.00	-0.2 units on a scale Standard Deviation 0.42
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score Day 140 Right Treatment Area	-0.3 units on a scale Standard Deviation 0.49	-0.1 units on a scale Standard Deviation 0.35	-0.1 units on a scale Standard Deviation 0.35	-0.2 units on a scale Standard Deviation 0.42
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score Day 180 Left Treatment Area	-0.3 units on a scale Standard Deviation 0.49	-0.1 units on a scale Standard Deviation 0.64	-0.1 units on a scale Standard Deviation 0.35	-0.6 units on a scale Standard Deviation 0.52
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score Day 180 Right Treatment Area	-0.3 units on a scale Standard Deviation 0.49	-0.1 units on a scale Standard Deviation 0.64	-0.1 units on a scale Standard Deviation 0.35	-0.5 units on a scale Standard Deviation 0.53

SECONDARY outcome

Timeframe: Day 180

Population: mITT Population: All enrolled participants who received at least 1 injection of CCH and were assessed for anti-AUX-I and anti-AUX-II Antibodies at the specified timepoint. Immunogenicity analysis was conducted by overall participants and not treatment area/injection technique.

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.

Outcome measures

Outcome measures
Measure	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) n=32 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).
Percentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies Anti-AUX-I Antibodies	100 percentage of participants	—	—	—
Percentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies Anti-AUX-II Antibodies	100 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 180

Population: mITT Population: All enrolled participants who received at least 1 injection of CCH and who had an assessment as the specified timepoint. Immunogenicity analysis was conducted by overall participants and not treatment area/injection technique.

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.

Outcome measures

Outcome measures
Measure	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) n=32 Participants Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).
Percentage of Participants Positive for Neutralizing Antibodies to AUX-I and AUX-II Neutralizing antibodies to AUX-I	87.5 percentage of participants	—	—	—
Percentage of Participants Positive for Neutralizing Antibodies to AUX-I and AUX-II Neutralizing antibodies to AUX-II	84.4 percentage of participants	—	—	—

Adverse Events

Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks or Thighs)

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks or Thighs)

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Clinical Operations

Endo Pharmaceuticals

Phone: 1-800-462-3636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks or Thighs) n=16 participants at risk Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks or Thighs) n=19 participants at risk Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).
General disorders Fatigue	0.00% 0/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	5.3% 1/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
General disorders Implant site inflammation	0.00% 0/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	5.3% 1/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
General disorders Implant site pain	0.00% 0/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	5.3% 1/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
General disorders Injection site bruising	100.0% 16/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	100.0% 19/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
General disorders Injection site discolouration	6.2% 1/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	5.3% 1/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
General disorders Injection site mass	0.00% 0/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	5.3% 1/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
General disorders Injection site pain	62.5% 10/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	68.4% 13/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
General disorders Injection site pruritus	12.5% 2/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	10.5% 2/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
General disorders Injection site swelling	62.5% 10/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	52.6% 10/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
General disorders Injection site urticaria	6.2% 1/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	0.00% 0/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
Infections and infestations Ear infection	6.2% 1/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	0.00% 0/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
Infections and infestations Nasopharyngitis	0.00% 0/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	5.3% 1/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
Investigations SARS-CoV-2 test positive	0.00% 0/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	5.3% 1/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	5.3% 1/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
Product Issues Device breakage	0.00% 0/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	5.3% 1/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
Psychiatric disorders Alcoholism	6.2% 1/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	0.00% 0/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
Skin and subcutaneous tissue disorders Pityriasis rosea	0.00% 0/16 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.	5.3% 1/19 • Day 1 (after dosing) through Day 180 Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.