CompletedNCT04677712MOBIUpdated Aug 21, 2023Results posted

Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite

A Phase 4 interventional study of CCH-aaes and Compression in Edematous Fibrosclerotic Panniculopathy (EFP) and Cellulite, sponsored by Endo Pharmaceuticals. Completed at 8 sites in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Endo Pharmaceuticals (part of Keenova Therapeutics plc) · Phase 4, Interventional, and Prevention

Phase: Phase 4
Study type: Interventional
Enrollment: 48
Allocation: Non-randomized
Ages: 18 Years to 50 Years
Sex: Female

Study summary

This study will investigate treatments that may mitigate bruising after QWO™ (Collagenase clostridium histolyticum [CCH]-aaes) treatment of cellulite in the buttocks.

Read the 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.

Conditions studied

Edematous Fibrosclerotic Panniculopathy (EFP)
Cellulite

Browse trials for

Cellulite 71

Keywords

Bruising mitigation
CCH-aaes

In context

Cellulite

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

This study's enrollment of 48 is above the median of 34 across 65 interventional studies indexed under Cellulite.

Browse Cellulite studies →

Lead sponsor

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

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

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

Browse Endo Pharmaceuticals studies →All Keenova Therapeutics plc studies →

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

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Eligibility criteria

Key Inclusion Criteria:

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).
Have a between ≥18 and ≤30 kilograms (kg)/square meter (m\^2).
Be willing to apply sunscreen before each exposure to the sun while participating in the study (that is, Baseline through end of study).
Be judged to be in good health.
Be willing and able to cooperate with the requirements of the study.

Key Exclusion Criteria:

Has a coagulation disorder including but not limited to a Factor II, V, VII, or X deficiency.
Has local conditions in the areas to be treated (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
Has skin laxity or linear undulations on buttocks that can be effaced by lifting skin.
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.
Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
Is pregnant and/or is presently nursing or providing breast milk or plans to become pregnant during the study.
Intends to initiate an intensive sport or exercise program during the study.
Tanning or use of tanning agents.
Intends to engage in strenuous activity within 48 hours after the first injection of CCH-aaes.
Has received an drug or treatment within 30 days prior to injection of CCH-aaes.
Has a history of or allergy to collagenase or any other of CCH-aaes.
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).
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.
For participants allocated to PDL treatment Participants will be excluded from PDL treatment if they have any to PDL a. exposure to Accutane® (isotretinoin) within 6 months of CCH-aaes treatment.

Terms in these criteria, in plain language(5)

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

BMI (body mass index)

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

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

Investigational drug or device

A drug or device being studied in a clinical trial.

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

Hypersensitivity

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

Excipients

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

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 48 participants (actual)

Study arms

Active comparator
Cohort 1: CCH-aaes
CCH-aaes was administered without mitigation treatment (control group).
Drug: CCH-aaes
Active comparator
Cohort 2: CCH-aaes + Compression Garment
CCH-aaes was administered with compression garment.
Other: Compression
Active comparator
Cohort 3: CCH-aaes + Instant Cold Packs
CCH-aaes was administered with instant cold packs.
Other: Cold Packs
Active comparator
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
CCH-aaes was administered with arnica gel patches (OcuMend).
Drug: Arnica Gel
Active comparator
Cohort 5:CCH-aaes + INhance Post-Injection Serum with TriHex Technology®
CCH-aaes was administered with INhance Post-Injection Serum with TriHex Technology®
Drug: INhance®
Active comparator
Cohort 6: CCH-aaes + Pulse Dye Laser Treatment (PDL)
CCH-aaes was administered with PDL.
Other: PDL

Interventions

DrugCCH-aaes
Participants were administered CCH-aaes by subcutaneous injection to both buttocks.
Also known as: QWO™
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.

What researchers measure

Primary outcomes

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)

Secondary outcomes

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
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
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
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
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
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
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

Results

Posted Aug 21, 2023

Participant flow

Participant flow — Overall Study
Milestone	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 + Pulse Dye Laser Treatment (PDL)
Started	7	8	9	9	8	7
Received at least 1 dose of study drug	7	8	9	9	8	7
Completed	7	7	9	9	8	7
Not completed	0	1	0	0	0	0
Withdrew: Lost to follow-up	0	1	0	0	0	0

Outcome measures

PrimaryNumber 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)
Reported as:: Count of participants · Participants

Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
Participants	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 + Post-Injection Serum With TriHex Technology®	Cohort 6: CCH-aaes + PDL
Left Buttock (control): None or almost no bruising (0)	0	0	0	0	0	0
Right Buttock: None or almost no bruising (0)	0	0	0	0	0	0
Left Buttock (control): mild bruising (1)	2	2	5	1	1	3
Right Buttock: mild bruising (1)	2	3	5	1	1	4
Left Buttock (control): Moderate bruising (2)	1	3	3	3	2	2
Right Buttock: Moderate bruising (2)	1	2	3	4	3	2
Left Buttock (control): severe bruising (3)	3	3	1	4	5	1
Right Buttock: severe bruising (3)	3	3	1	3	4	1
Left Buttock (control): very severe bruising (4)	1	0	0	1	0	1
Right Buttock: severe bruising (4)	1	0	0	1	0	0

SecondaryNumber 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
Reported as:: Count of participants · Participants

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)
Participants	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
Day 4	2	4	2	4
Day 7	4	5	5	4

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS)
Participants	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
Day 4	0	3	1	3
Day 7	4	4	3	4

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4
Participants	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
Left Buttock (control): Not at all bothered (1)	3	5	9	5	4	1
Right Buttock: Not at all bothered (1)	3	5	9	5	4	1
Left Buttock (control): A little bothered (2)	3	2	0	2	2	4
Right Buttock: A little bothered (2)	3	2	0	2	2	4
Left Buttock (control): Moderately bothered (3)	1	1	0	2	2	1
Right Buttock: Moderately bothered (3)	1	1	0	2	2	1
Left Buttock (control): Extremely bothered (4)	0	0	0	0	0	1
Right Buttock: Extremely bothered (4)	0	0	0	0	0	1

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71
Participants	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
Left Buttock (control)	6	6	9	9	7	5
Right Buttock	6	6	9	9	7	6

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7
Participants	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 + Post-Injection Serum With TriHex Technology®	Cohort 6: CCH-aaes + PDL
Left Buttock (control): None or almost no bruising (0)	0	0	0	0	0	1
Right Buttock: None or almost no bruising (0)	0	0	0	0	0	1
Left Buttock (control): mild bruising (1)	2	2	6	5	3	4
Right Buttock: mild bruising (1)	2	2	6	5	3	4
Left Buttock (control): Moderate bruising (2)	4	4	2	4	3	1
Right Buttock: Moderate bruising (2)	4	4	2	4	3	1
Left Buttock (control): severe bruising (3)	1	2	1	0	1	1
Right Buttock: severe bruising (3)	1	2	1	0	1	1
Left Buttock (control): very severe bruising (4)	0	0	0	0	1	0
Right Buttock: severe bruising (4)	0	0	0	0	1	0

SecondaryThe Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14

Time frame:: Day 14
Reported as:: Count of participants · Participants

The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14
Participants	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 + Post-Injection Serum With TriHex Technology®	Cohort 6: CCH-aaes + PDL
Left Buttock (control): None or almost no bruising (0)	3	5	8	7	4	3
Right Buttock: None or almost no bruising (0)	3	6	9	8	4	3
Left Buttock (control): mild bruising (1)	4	2	1	2	2	4
Right Buttock: mild bruising (1)	4	1	0	1	4	4
Left Buttock (control): Moderate bruising (2)	0	0	0	0	2	0
Right Buttock: Moderate bruising (2)	0	0	0	0	0	0
Left Buttock (control): severe bruising (3)	0	0	0	0	0	0
Right Buttock: severe bruising (3)	0	0	0	0	0	0
Left Buttock (control): very severe bruising (4)	0	0	0	0	0	0
Right Buttock: severe bruising (4)	0	0	0	0	0	0

SecondaryThe Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22

Time frame:: Day 22
Reported as:: Count of participants · Participants

The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22
Participants	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 + Post-Injection Serum With TriHex Technology®	Cohort 6: CCH-aaes + PDL
Left Buttock (control): None or almost no bruising (0)	6	7	9	9	6	7
Right Buttock: None or almost no bruising (0)	6	7	9	9	7	7
Left Buttock (control): mild bruising (1)	0	0	0	0	2	0
Right Buttock: mild bruising (1)	0	0	0	0	1	0
Left Buttock (control): Moderate bruising (2)	0	0	0	0	0	0
Right Buttock: Moderate bruising (2)	0	0	0	0	0	0
Left Buttock (control): severe bruising (3)	0	0	0	0	0	0
Right Buttock: severe bruising (3)	0	0	0	0	0	0
Left Buttock (control): very severe bruising (4)	0	0	0	0	0	0
Right Buttock: severe bruising (4)	0	0	0	0	0	0

Adverse events

Collected over Day 1 (after dosing) through Day 71. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1: CCH-aaes	0/7 (0%)	0/7 (0%)	6/7 (85.7%)
Cohort 2: CCH-aaes + Compression Garment	0/8 (0%)	0/8 (0%)	8/8 (100%)
Cohort 3:CCH-aaes + Instant Cold Packs	0/9 (0%)	0/9 (0%)	9/9 (100%)
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)	0/9 (0%)	0/9 (0%)	9/9 (100%)
Cohort 5: CCH-aaes + INhance Post-Injection Serum With TriHex Technology®	0/8 (0%)	0/8 (0%)	8/8 (100%)
Cohort 6: CCH-aaes + PDL	0/7 (0%)	0/7 (0%)	6/7 (85.7%)

Most frequent other events

Most frequent other events
Event	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
Injection site bruisingGeneral disorders	6/7	8/8	9/9	9/9	8/8	6/7
Injection site painGeneral disorders	4/7	5/8	7/9	7/9	5/8	5/7
Injection site discolourationGeneral disorders	2/7	2/8	4/9	2/9	2/8	2/7
Injection site noduleGeneral disorders	1/7	2/8	2/9	0/9	0/8	3/7
Injection site pruritusGeneral disorders	0/7	1/8	0/9	0/9	0/8	0/7
ContusionInjury, poisoning and procedural complications	0/7	0/8	0/9	1/9	1/8	0/7

Baseline characteristics

Safety Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes with or without mitigation treatment

Age, Continuous
Age, Continuous(years)	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
Mean	39.5 ± 6.32	37.8 ± 9.06	38.4 ± 6.85	37.8 ± 7.37	41.4 ± 8.01	39.4 ± 5.88	39.0 ± 7.08

Sex: Female, Male
Sex: Female, Male(Participants)	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
Female	7	8	9	9	8	7	48
Male	0	0	0	0	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	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
Hispanic or Latino	2	0	0	1	1	2	6
Not Hispanic or Latino	5	8	9	8	7	5	42
Unknown or Not Reported	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	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
American Indian or Alaska Native	0	0	0	0	0	0	0
Asian	0	0	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0
Black or African American	0	1	0	0	0	0	1
White	7	7	9	9	8	7	47
More than one race	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	0

Body Mass Index
Body Mass Index(kg/m^2)	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
Mean	24.46 ± 3.182	26.54 ± 2.729	24.68 ± 3.440	25.50 ± 3.094	26.81 ± 2.645	24.97 ± 2.759	25.51 ± 2.978

Fitzpatrick Skin Rating
Fitzpatrick Skin Rating(units on a scale)	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
I (Pale White)	0	2	0	1	0	0	3
II (Fair)	3	2	5	4	5	3	22
III (Darker White)	4	4	4	4	3	4	23

Study locations

8 sites

Endo Clinical Trial Site #3
Scottsdale, Arizona 85255, United States
Endo Clinical Trial Site #2
Sacramento, California 95816, United States
Endo Clinical Trial Site #7
San Diego, California 92122, United States
Endo Clinical Trial Site #6
Fort Collins, Colorado 80525, United States
Endo Clinical Trial Site #5
Chicago, Illinois 60611, United States
Endo Clinical Trial Site #1
Shreveport, Louisiana 71105, United States
Endo Clinical Trial Site #8
Boston, Massachusetts 02114, United States
Endo Clinical Trial Site #4
Nashville, Tennessee 37203, United States

References and documents

Study documents

Study protocol ↗ · May 20, 2022
Statistical analysis plan ↗ · Feb 10, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2020 to primary completion in Jun 2021, 5 months.

Results were first posted in Aug 2023, 2 years 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 17, 2020
First posted: Dec 21, 2020
StartActual: Dec 28, 2020
Primary completionActual: Jun 26, 2021
CompletionActual: Sep 2, 2021
Results first posted: Aug 21, 2023
Last update: Aug 21, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04677712
Lead sponsor: Endo Pharmaceuticals
Collaborators: 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.
Responsible party: Sponsor
First posted: Dec 21, 2020
Start date: Dec 28, 2020
Primary completion: Jun 26, 2021
Completion: Sep 2, 2021
Results posted: Aug 21, 2023
Last update: Aug 21, 2023

Study contacts

Medical Affairs

study director · Endo Pharmaceuticals

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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