Edematous Fibrosclerotic Panniculopathy (EFP), Cellulite
Conditions
Keywords
Bruising mitigation, CCH-aaes
Brief summary
This study will investigate treatments that may mitigate bruising after QWO™ (Collagenase clostridium histolyticum \[CCH\]-aaes) treatment of cellulite in the buttocks.
Detailed description
CCH-aaes is indicated for the treatment of moderate to severe cellulite in the buttocks of adult women. Since bruising may be bothersome, this study will investigate treatments that may mitigate bruising after treatment of cellulite in the buttocks.
Interventions
DRUGCCH-aaes
Participants were administered CCH-aaes by subcutaneous injection to both buttocks.
OTHERCompression
Participants used a compression garment on both buttocks following subcutaneous CCH-aaes injections.
OTHERCold Packs
Participants used cold packs applied to the right buttock for 5-10 minutes immediately after subcutaneous CCH-aaes injections.
DRUGArnica Gel
Participants used Arnica Gel Patches (Arnica montana 50% and Ledum palustre) immediately after the CCH-aaes injection to the right buttock.
DRUGINhance®
Participants used INhance Post-injection Serum topically immediately after the CCH-aaes injection to the right buttock.
OTHERPDL
Investigators applied one treatment with PDL to the right buttock between days 1-7 after injection.
Sponsors
DeNova Research
University of California, San Diego
The Wall Center for Plastic Surgery
Mathew Avram, MD
Laser & Skin Surgery Medical Group, Inc.
Investigate MD, LLC
Biesman, Brian, M.D.
Plastic Surgical Associates of Fort Collins, P.C.
Endo Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Have both buttocks with: 1. Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) score of 3 (moderate) as reported by the Investigator, and 2. Hexsel Cellulite Severity Scale (CSS) Subsection D Grade of laxity, flaccidity, or sagging skin score of 0 (absence of laxity, flaccidity, or sagging skin) or 1 (slightly draped appearance). 2. Have a body mass index between ≥18 and ≤30 kilograms (kg)/square meter (m\^2). 3. Be willing to apply sunscreen before each exposure to the sun while participating in the study (that is, Baseline through end of study). 4. Be judged to be in good health. 5. Be willing and able to cooperate with the requirements of the study. Key
Exclusion criteria
1. Has a coagulation disorder including but not limited to a Factor II, V, VII, or X deficiency. 2. Has local conditions in the areas to be treated (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation. 3. Has skin laxity or linear undulations on buttocks that can be effaced by lifting skin. 4. Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before CCH-aaes treatment. 1. Antiplatelet medication (clopidogrel \[Plavix®\] including aspirin at any dose within 14 days of treatment. 2. Anticoagulants, such as warfarin (Coumadin®); heparin analogues within 14 days of treatment. 3. Non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen (Motrin®, Advil®) and naproxen (Aleve®) 7 days before the study. 4. Any medications or food that have or have been reported to have anticoagulant effects within 14 days of treatment. 5. Antibiotics, such as penicillin and cephalosporin within 48 hours of treatment. 5. Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation. 6. Is pregnant and/or is presently nursing or providing breast milk or plans to become pregnant during the study. 7. Intends to initiate an intensive sport or exercise program during the study. 8. Tanning or use of tanning agents. 9. Intends to engage in strenuous activity within 48 hours after the first injection of CCH-aaes. 10. Has received an investigational drug or treatment within 30 days prior to injection of CCH-aaes. 11. Has a history of hypersensitivity or allergy to collagenase or any other excipient of CCH-aaes. 12. Has a known systemic allergy or local sensitivity to any of the mitigation treatments or including excipients (that is, arnica patches, INhance Post-injection Serum). 13. Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH-aaes in a previous investigational study for cellulite. 14. For participants allocated to PDL treatment Participants will be excluded from PDL treatment if they have any contraindications to PDL a. exposure to Accutane® (isotretinoin) within 6 months of CCH-aaes treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Day 4 (3 days after CCH-aaes injection) | Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-point photonumeric scale ranging from 0 to 4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS) | Days 4 and 7 | The investigator assessed improvement of bruising using the S-BIS, a 3-point Likert scale that compares bruising on the mitigated side to the bruising on the non-mitigated side as either worse (1), the same (2), or improved (3). S-BIS Rating was directly obtained from the participant's assessment rating comparing the bruising of the mitigation-treated buttock to the untreated (with mitigation treatment) buttock. The S-BIS assessment was not completed for participants that did not receive mitigation treatment (Cohort 1) or participants that received bilateral mitigation treatment (Cohort 2), as these participants did not have an untreated buttock as a comparator. |
| Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Day 4 | The Patient Bother by Bruising Scale is a 4-point scale, with a score of 1 indicating not bothered at all, and a score of 4, indicating extremely bothered. A lower score indicates a better outcome. |
| Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 | Day 71 | Improvement was defined as +1 or better score on the I-GAIS for either buttock on Day 71 compared to Baseline. The I-GAIS is a 7-level scale ranging from +3 (very much improved) to -3 (very much worse). A higher score indicated a better outcome. |
| Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS) | Days 4 and 7 | The investigator assessed improvement of bruising using the I-BIS, a 3-point Likert scale that compares bruising on the mitigated side to the bruising on the non-mitigated side as either worse (1), the same (2), or improved (3). I-BIS Rating was directly obtained from the investigator's assessment rating comparing the bruising of the mitigation-treated buttock to the untreated (with mitigation treatment) buttock. |
| The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Day 14 | Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome. |
| The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Day 22 | Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome. |
| Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Day 7 | Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: CCH-aaes CCH-aaes was administered to both buttocks without mitigation treatment (control group). | 7 |
| Cohort 2: CCH-aaes + Compression Garment CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment. | 8 |
| Cohort 3: CCH-aaes + Instant Cold Packs CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment. | 9 |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment. | 9 |
| Cohort 5:CCH-aaes + INhance Post-Injection Serum With TriHex Technology® CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment. | 8 |
| Cohort 6: CCH-aaes + PDL CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment. | 7 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: CCH-aaes | Cohort 2: CCH-aaes + Compression Garment | Cohort 3: CCH-aaes + Instant Cold Packs | Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Cohort 5:CCH-aaes + INhance Post-Injection Serum With TriHex Technology® | Cohort 6: CCH-aaes + PDL | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 39.5 years STANDARD_DEVIATION 6.32 | 37.8 years STANDARD_DEVIATION 9.06 | 38.4 years STANDARD_DEVIATION 6.85 | 37.8 years STANDARD_DEVIATION 7.37 | 41.4 years STANDARD_DEVIATION 8.01 | 39.4 years STANDARD_DEVIATION 5.88 | 39.0 years STANDARD_DEVIATION 7.08 |
| Body Mass Index | 24.46 kg/m^2 STANDARD_DEVIATION 3.182 | 26.54 kg/m^2 STANDARD_DEVIATION 2.729 | 24.68 kg/m^2 STANDARD_DEVIATION 3.44 | 25.50 kg/m^2 STANDARD_DEVIATION 3.094 | 26.81 kg/m^2 STANDARD_DEVIATION 2.645 | 24.97 kg/m^2 STANDARD_DEVIATION 2.759 | 25.51 kg/m^2 STANDARD_DEVIATION 2.978 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 8 Participants | 9 Participants | 8 Participants | 7 Participants | 5 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Rating II (Fair) | 3 units on a scale | 2 units on a scale | 5 units on a scale | 4 units on a scale | 5 units on a scale | 3 units on a scale | 22 units on a scale |
| Fitzpatrick Skin Rating III (Darker White) | 4 units on a scale | 4 units on a scale | 4 units on a scale | 4 units on a scale | 3 units on a scale | 4 units on a scale | 23 units on a scale |
| Fitzpatrick Skin Rating I (Pale White) | 0 units on a scale | 2 units on a scale | 0 units on a scale | 1 units on a scale | 0 units on a scale | 0 units on a scale | 3 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 7 Participants | 9 Participants | 9 Participants | 8 Participants | 7 Participants | 47 Participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 9 Participants | 9 Participants | 8 Participants | 7 Participants | 48 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 6 / 7 | 8 / 8 | 9 / 9 | 9 / 9 | 8 / 8 | 6 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 7 |
Outcome results
Primary
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-point photonumeric scale ranging from 0 to 4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome.
Time frame: Day 4 (3 days after CCH-aaes injection)
Population: Evaluable Population: All participants allocated to treatment who receive at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: severe bruising (3) | 3 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): severe bruising (3) | 3 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: Moderate bruising (2) | 1 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: severe bruising (4) | 1 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): Moderate bruising (2) | 1 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): mild bruising (1) | 2 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: mild bruising (1) | 2 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: None or almost no bruising (0) | 0 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): None or almost no bruising (0) | 0 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): very severe bruising (4) | 1 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: None or almost no bruising (0) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: mild bruising (1) | 3 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): None or almost no bruising (0) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): Moderate bruising (2) | 3 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: severe bruising (3) | 3 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: Moderate bruising (2) | 2 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): mild bruising (1) | 2 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): severe bruising (3) | 3 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): Moderate bruising (2) | 3 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: Moderate bruising (2) | 3 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: None or almost no bruising (0) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): mild bruising (1) | 5 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: severe bruising (3) | 1 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: mild bruising (1) | 5 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): severe bruising (3) | 1 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): None or almost no bruising (0) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): very severe bruising (4) | 1 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): None or almost no bruising (0) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: None or almost no bruising (0) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): mild bruising (1) | 1 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: mild bruising (1) | 1 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): Moderate bruising (2) | 3 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: Moderate bruising (2) | 4 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): severe bruising (3) | 4 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: severe bruising (3) | 3 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: severe bruising (4) | 1 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: mild bruising (1) | 1 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: None or almost no bruising (0) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): severe bruising (3) | 5 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): mild bruising (1) | 1 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): None or almost no bruising (0) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: Moderate bruising (2) | 3 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: severe bruising (3) | 4 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): Moderate bruising (2) | 2 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): Moderate bruising (2) | 2 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: mild bruising (1) | 4 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): severe bruising (3) | 1 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): mild bruising (1) | 3 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: None or almost no bruising (0) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: severe bruising (3) | 1 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): very severe bruising (4) | 1 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Left Buttock (control): None or almost no bruising (0) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Right Buttock: Moderate bruising (2) | 2 Participants |
Secondary
Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4
The Patient Bother by Bruising Scale is a 4-point scale, with a score of 1 indicating not bothered at all, and a score of 4, indicating extremely bothered. A lower score indicates a better outcome.
Time frame: Day 4
Population: Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: CCH-aaes | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Not at all bothered (1) | 3 Participants |
| Cohort 1: CCH-aaes | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): A little bothered (2) | 3 Participants |
| Cohort 1: CCH-aaes | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Not at all bothered (1) | 3 Participants |
| Cohort 1: CCH-aaes | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Extremely bothered (4) | 0 Participants |
| Cohort 1: CCH-aaes | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Extremely bothered (4) | 0 Participants |
| Cohort 1: CCH-aaes | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Moderately bothered (3) | 1 Participants |
| Cohort 1: CCH-aaes | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: A little bothered (2) | 3 Participants |
| Cohort 1: CCH-aaes | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Moderately bothered (3) | 1 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Moderately bothered (3) | 1 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Extremely bothered (4) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Not at all bothered (1) | 5 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): A little bothered (2) | 2 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Extremely bothered (4) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: A little bothered (2) | 2 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Not at all bothered (1) | 5 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Moderately bothered (3) | 1 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Not at all bothered (1) | 9 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Moderately bothered (3) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Moderately bothered (3) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Extremely bothered (4) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: A little bothered (2) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Extremely bothered (4) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): A little bothered (2) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Not at all bothered (1) | 9 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): A little bothered (2) | 2 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Extremely bothered (4) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Extremely bothered (4) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: A little bothered (2) | 2 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Moderately bothered (3) | 2 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Not at all bothered (1) | 5 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Not at all bothered (1) | 5 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Moderately bothered (3) | 2 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Not at all bothered (1) | 4 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Not at all bothered (1) | 4 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): A little bothered (2) | 2 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: A little bothered (2) | 2 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Moderately bothered (3) | 2 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Moderately bothered (3) | 2 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Extremely bothered (4) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Extremely bothered (4) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Extremely bothered (4) | 1 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Extremely bothered (4) | 1 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: A little bothered (2) | 4 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): A little bothered (2) | 4 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Not at all bothered (1) | 1 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Not at all bothered (1) | 1 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Right Buttock: Moderately bothered (3) | 1 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | Left Buttock (control): Moderately bothered (3) | 1 Participants |
Secondary
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7
Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome.
Time frame: Day 7
Population: Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): Moderate bruising (2) | 4 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: Moderate bruising (2) | 4 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: severe bruising (3) | 1 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): None or almost no bruising (0) | 0 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: None or almost no bruising (0) | 0 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): mild bruising (1) | 2 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: mild bruising (1) | 2 Participants |
| Cohort 1: CCH-aaes | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): severe bruising (3) | 1 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: mild bruising (1) | 2 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): None or almost no bruising (0) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: severe bruising (3) | 2 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: None or almost no bruising (0) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): mild bruising (1) | 2 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: Moderate bruising (2) | 4 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): severe bruising (3) | 2 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): Moderate bruising (2) | 4 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: mild bruising (1) | 6 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): Moderate bruising (2) | 2 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): None or almost no bruising (0) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): mild bruising (1) | 6 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: Moderate bruising (2) | 2 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: severe bruising (3) | 1 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: None or almost no bruising (0) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): severe bruising (3) | 1 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): None or almost no bruising (0) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: None or almost no bruising (0) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): mild bruising (1) | 5 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: mild bruising (1) | 5 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): Moderate bruising (2) | 4 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: Moderate bruising (2) | 4 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): severe bruising (3) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: severe bruising (3) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: mild bruising (1) | 3 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): severe bruising (3) | 1 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): mild bruising (1) | 3 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): None or almost no bruising (0) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): very severe bruising (4) | 1 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: None or almost no bruising (0) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: severe bruising (4) | 1 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): Moderate bruising (2) | 3 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: severe bruising (3) | 1 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: Moderate bruising (2) | 3 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: severe bruising (3) | 1 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: mild bruising (1) | 4 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): severe bruising (3) | 1 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: Moderate bruising (2) | 1 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): mild bruising (1) | 4 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Right Buttock: None or almost no bruising (0) | 1 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): Moderate bruising (2) | 1 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Left Buttock (control): None or almost no bruising (0) | 1 Participants |
Secondary
Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS)
The investigator assessed improvement of bruising using the I-BIS, a 3-point Likert scale that compares bruising on the mitigated side to the bruising on the non-mitigated side as either worse (1), the same (2), or improved (3). I-BIS Rating was directly obtained from the investigator's assessment rating comparing the bruising of the mitigation-treated buttock to the untreated (with mitigation treatment) buttock.
Time frame: Days 4 and 7
Population: Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes. The I-BIS assessment was not completed for participants that did not receive mitigation treatment (Cohort 1) or participants that received bilateral mitigation treatment (Cohort 2), as these participants did not have an untreated buttock as a comparator.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: CCH-aaes | Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS) | Day 4 | 2 Participants |
| Cohort 1: CCH-aaes | Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS) | Day 7 | 4 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS) | Day 7 | 5 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS) | Day 4 | 4 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS) | Day 4 | 2 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS) | Day 7 | 5 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS) | Day 4 | 4 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS) | Day 7 | 4 Participants |
Secondary
Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71
Improvement was defined as +1 or better score on the I-GAIS for either buttock on Day 71 compared to Baseline. The I-GAIS is a 7-level scale ranging from +3 (very much improved) to -3 (very much worse). A higher score indicated a better outcome.
Time frame: Day 71
Population: Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: CCH-aaes | Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 | Right Buttock | 6 Participants |
| Cohort 1: CCH-aaes | Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 | Left Buttock (control) | 6 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 | Right Buttock | 6 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 | Left Buttock (control) | 6 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 | Left Buttock (control) | 9 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 | Right Buttock | 9 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 | Left Buttock (control) | 9 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 | Right Buttock | 9 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 | Left Buttock (control) | 7 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 | Right Buttock | 7 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 | Right Buttock | 6 Participants |
| Cohort 6: CCH-aaes + PDL | Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 | Left Buttock (control) | 5 Participants |
Secondary
Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS)
The investigator assessed improvement of bruising using the S-BIS, a 3-point Likert scale that compares bruising on the mitigated side to the bruising on the non-mitigated side as either worse (1), the same (2), or improved (3). S-BIS Rating was directly obtained from the participant's assessment rating comparing the bruising of the mitigation-treated buttock to the untreated (with mitigation treatment) buttock. The S-BIS assessment was not completed for participants that did not receive mitigation treatment (Cohort 1) or participants that received bilateral mitigation treatment (Cohort 2), as these participants did not have an untreated buttock as a comparator.
Time frame: Days 4 and 7
Population: Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes. The S-BIS assessment was not completed for participants that did not receive mitigation treatment (Cohort 1) or participants that received bilateral mitigation treatment (Cohort 2), as these participants did not have an untreated buttock as a comparator.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: CCH-aaes | Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS) | Day 4 | 0 Participants |
| Cohort 1: CCH-aaes | Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS) | Day 7 | 4 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS) | Day 7 | 4 Participants |
| Cohort 2: CCH-aaes + Compression Garment | Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS) | Day 4 | 3 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS) | Day 4 | 1 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS) | Day 7 | 3 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS) | Day 4 | 3 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS) | Day 7 | 4 Participants |
Secondary
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14
Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome.
Time frame: Day 14
Population: Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): mild bruising (1) | 4 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): Moderate bruising (2) | 0 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: None or almost no bruising (0) | 3 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: mild bruising (1) | 4 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): None or almost no bruising (0) | 3 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): severe bruising (3) | 0 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: severe bruising (3) | 0 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: Moderate bruising (2) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: Moderate bruising (2) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): severe bruising (3) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: severe bruising (3) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): None or almost no bruising (0) | 5 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: None or almost no bruising (0) | 6 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): mild bruising (1) | 2 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: mild bruising (1) | 1 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): Moderate bruising (2) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): None or almost no bruising (0) | 8 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): mild bruising (1) | 1 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): severe bruising (3) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: Moderate bruising (2) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): Moderate bruising (2) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: severe bruising (3) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: None or almost no bruising (0) | 9 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: mild bruising (1) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): mild bruising (1) | 2 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): severe bruising (3) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: Moderate bruising (2) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: mild bruising (1) | 1 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: severe bruising (3) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): Moderate bruising (2) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: None or almost no bruising (0) | 8 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): None or almost no bruising (0) | 7 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: mild bruising (1) | 4 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: severe bruising (3) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): None or almost no bruising (0) | 4 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: None or almost no bruising (0) | 4 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): mild bruising (1) | 2 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: Moderate bruising (2) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): Moderate bruising (2) | 2 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): severe bruising (3) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): Moderate bruising (2) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: mild bruising (1) | 4 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): mild bruising (1) | 4 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: None or almost no bruising (0) | 3 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): None or almost no bruising (0) | 3 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: severe bruising (3) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Right Buttock: Moderate bruising (2) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Left Buttock (control): severe bruising (3) | 0 Participants |
Secondary
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22
Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome.
Time frame: Day 22
Population: Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: Moderate bruising (2) | 0 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: mild bruising (1) | 0 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): severe bruising (3) | 0 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): mild bruising (1) | 0 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): None or almost no bruising (0) | 6 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: None or almost no bruising (0) | 6 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): Moderate bruising (2) | 0 Participants |
| Cohort 1: CCH-aaes | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: severe bruising (3) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): None or almost no bruising (0) | 7 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: mild bruising (1) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): mild bruising (1) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): severe bruising (3) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: Moderate bruising (2) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: severe bruising (3) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): Moderate bruising (2) | 0 Participants |
| Cohort 2: CCH-aaes + Compression Garment | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: None or almost no bruising (0) | 7 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: mild bruising (1) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): None or almost no bruising (0) | 9 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: None or almost no bruising (0) | 9 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): Moderate bruising (2) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): severe bruising (3) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: severe bruising (3) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): mild bruising (1) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: Moderate bruising (2) | 0 Participants |
| Cohort 3: CCH-aaes + Instant Cold Packs | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): None or almost no bruising (0) | 9 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): mild bruising (1) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: severe bruising (3) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): Moderate bruising (2) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): severe bruising (3) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: Moderate bruising (2) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: mild bruising (1) | 0 Participants |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: None or almost no bruising (0) | 9 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): severe bruising (3) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): mild bruising (1) | 2 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: mild bruising (1) | 1 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: severe bruising (3) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): Moderate bruising (2) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: Moderate bruising (2) | 0 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): None or almost no bruising (0) | 6 Participants |
| Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: None or almost no bruising (0) | 7 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): very severe bruising (4) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): severe bruising (3) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): Moderate bruising (2) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): None or almost no bruising (0) | 7 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: None or almost no bruising (0) | 7 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: mild bruising (1) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: severe bruising (3) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: severe bruising (4) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Left Buttock (control): mild bruising (1) | 0 Participants |
| Cohort 6: CCH-aaes + PDL | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Right Buttock: Moderate bruising (2) | 0 Participants |