Edematous Fibrosclerotic PanniculopathyPhase 2APHRODITENCT05419505

Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks

A Phase 2 study testing CCH-aaes and Antifibrinolytic Agent in people with Edematous Fibrosclerotic Panniculopathy and Cellulite, run by Endo USA Inc., a Keenova Therapeutics Company at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will evaluate the effect of different doses, strengths (concentrations), diluent additives, depths of injection, and methods of injection on the severity of bruising potentially induced by QWO (collagenase clostridium histolyticum-aaes [CCH-aaes]). Read more about this study

Who is it for?: Ages 18 to 60 years, women only
Conditions the study is for: Edematous Fibrosclerotic Panniculopathy, Cellulite
What is being tested?: CCH-aaes and Antifibrinolytic Agent
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 13 sitesUnited States
Study dates: 15 Jun 2022to 21 Jun 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Women only
No healthy volunteers
Adult

Who may be able to join

Have a body mass index of 18 to <32 kilograms (kg)/meter (m)^2 and intends to maintain stable body weight during the study.
Have both buttocks with moderate or severe cellulite as reported by the investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
Have a Hexsel Cellulite Severity Scale (CSS) Total Score of ≤12.
Has a Fitzpatrick Skin Type of I-IV
Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of participation in the study.
Be willing and able to comply with the requirements of the study.

Who cannot join

Has systemic conditions (coagulation disorders, skin pigmentation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation.
Is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study.
Has any local (in the areas to be treated) conditions (thrombosis, post-thrombosis syndrome, vascular disorder, inflammation, active infection, active cutaneous alteration, tattoo or mole) that restricts study participation.
Requires antiplatelet medication, anticoagulants, or non-steroidal anti-inflammatory drugs during the study.
Any medications, supplements, or foods that have, or have been reported to have anticoagulant effects within 14 days of treatment.
Has received treatment with investigational treatment within 30 days before treatment.

Show all 23Show fewer

Has used or intends to use any of the local applications, therapies, injections, or procedures for the treatment of cellulite on either buttock that would restrict study participation.
Intends to initiate an intensive sport or exercise program or intensive weight reduction program during the study.
Intends to engage in strenuous activity within 48 hours of study intervention administration.
Has recently tanned or intends to tan (outdoors or indoors) during the study.
Has a history of hypersensitivity or allergy to collagenase or any other excipient of CCH.
Has any condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
Has participated in a previous investigational study of CCH or received any collagenase treatments at any time prior to treatment in this study for the treatment of cellulite of the buttocks.
In addition to the applicable aforementioned exclusion criteria, participants enrolling in Cohort 7 will be excluded from study participation if the participant:
Has any of the following medical conditions:
history of venous or arterial thromboembolism or current thromboembolic disease.
history of or current renal impairment.
serum creatinine concentration > 1.4 milligram/deciliter at Screening.
Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before CCH-aaes treatment:
concurrently taking combination hormonal contraceptives.
concurrently undergoing hormone replacement therapy.
is a current smoker of nicotine or cannabinoids.
Participants in Cohort 7 should avoid smoking (including vaping, nicotine, or marijuana cigarettes) during the study.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Endo Clinical Trial Site #4
Beverly Hills, California, 90210
Endo Clinical Trial Site #3
Chicago, Illinois, 60611
Endo Clinical Trial Site #8
Coral Gables, Florida, 33146
Endo Clinical Trial Site #9
Encinitas, California, 92024
Endo Clinical Trial Site #12
Greenwood Village, Colorado, 80111
Endo Clinical Trial Site #2
Metairie, Louisiana, 700006
Endo Clinical Trial Site #13
Miami, Florida, 33137
Endo Clinical Trial Site #1
Nashville, Tennessee, 37215
Endo Clinical Trial Site #11
New York, New York, 10021
Endo Clinical Trial Site #5
Pflugerville, Texas, 78660
Endo Clinical Trial Site #10
San Diego, California, 92121
Endo Clinical Trial Site #6
Scottsdale, Arizona, 85255
Endo Clinical Trial Site #7
Solana Beach, California, 92075

Other trials in United States

About this study

Official title: APHRODITE-1: A Phase 2, Open Label, Self-Controlled Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks in Adult Females

Read the detailed description

The study will comprise a Screening Period (28 days), Treatment Period (90 days), and Follow-up Period (90 days). Participants will receive CCH-aaes in different doses, concentrations, diluent additives, depths of injection, and methods of injection in a split buttock arrangement, with the right buttock serving as the control, and the left buttock (investigational side) receiving a study intervention.

Conditions: Edematous Fibrosclerotic Panniculopathy, Cellulite
Being tested: CCH-aaes, Antifibrinolytic Agent
Keywords: Collagenase Clostridium Histolyticum, collagenase clostridium histolyticum-aaes
Medical subject headings: Cellulite

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CCH-aaesDrug
Also called Collagenase clostridium histolyticum-aaes, QWO®
Administered by subcutaneous injection.
Antifibrinolytic AgentDrug
Self-administered by participants enrolled in Cohort 7.

Study groups in NCT05419505
Study group	Role	What they receive
Cohort 1: CCH-aaes Dose Evaluation	Experimental	Participants will be administered CCH-aaes at different doses. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment. Receives: Drug: CCH-aaes
Cohort 2: CCH-aaes Concentration Evaluation	Experimental	Participants will be administered CCH-aaes at different concentrations. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment. Receives: Drug: CCH-aaes
Cohort 3: CCH-aaes Injection Depth Evaluation	Experimental	Participants will be administered CCH-aaes using different injection depths. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment. Receives: Drug: CCH-aaes
Cohort 4: CCH-aaes Injection Method Evaluation	Experimental	Participants will be administered CCH-aaes using different injection methods. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment. Receives: Drug: CCH-aaes
Cohort 5: CCH-aaes and Diluent Additive Evaluation	Experimental	Participants will be administered CCH-aaes and diluent additive. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment. Receives: Drug: CCH-aaes
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation	Experimental	Participants will be administered CCH-aaes using a different treatment schedule and different doses and concentrations. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment. Receives: Drug: CCH-aaes
Cohort 7: CCH-aaes and Antifibrinolytic Agent	Experimental	Participants will be administered CCH-aaes and an antifibrinolytic agent. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment. Receives: Drug: CCH-aaes; Drug: Antifibrinolytic Agent

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With at Least 1-Level Lower Score 3 to 5 Days After Initial CCH-aaes Injection, as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection
The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcomes.
The investigator compared the bruising of the left (test) buttock to the right (control) buttock. Responders were participants whose left buttock/test side demonstrated at least a 1-level lower IABSS score versus the right buttock/control side.
Percentages are based on the number of participants with an assessment at specified timepoint.
Measured: 3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control)

Secondary outcomes (3)

Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS
The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome.
The investigator compared the bruising of the left buttock (test) to the right (control) buttock. Responders were participants whose left buttock/test side at Visit A demonstrated at least a 1-level lower IABSS score versus the right buttock/control side at Visit B, where Visit A and B could either be the same or different. Follow-up after first injection is presented: Follow-up 1 is 1 to 2 days after injection visit, Follow-up 2 is 3 to 5 days after injection visit, Follow-up 3 is 6 to 9 days after injection visit, and Follow-up 4 is 10 to 14 days after injection visit.
Percentages are based on the number of participants with an assessment at specified timepoint.
Measured: Follow-up 1, 2, 3, and 4 after CCH-aaes injection of left buttock (test) and right buttock (control)
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
The investigator determined the degree of improvement of each buttock by comparing treated cellulite dimples from the Day 1 pre-treatment (Baseline) digital image of each buttock to the treated dimples observed in a live assessment.
The investigator determined the degree of improvement of each buttock with the I-GAIS, which uses a 7-point scale ranging from +3 (very much improved) to -3 (very much worse). A higher score indicated a better outcome. The investigator compared the bruising of the left (test) buttock to the right (control) buttock.
A 1-level I-GAIS responder was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at an analysis visit for that treatment area.
Percentages are based on the number of participants with an assessment at specified timepoint.
Measured: Day 22 and Day 43 for Cohorts 1 to 5, Day 43 for Cohort 6, Day 22, Day 43, and Day 64 for Cohort 7, and Day 90, Day 135, and Day 180 for all cohorts
Percentage of Participants With Injection Site Reactions
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that occur or worsen (increase in severity) on the same day or after the study intervention administration on Day 1. Percent of participants with TEAEs of injection site reactions are presented by left buttock (test) and right buttock (control).
A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: From Day 1 (after dose) through Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 202221 Jun 2023

First posted15 Jun 2022
Study start15 Jun 2022
Primary completion3 Jan 2023
Study completion21 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Edematous Fibrosclerotic PanniculopathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05419505
Sponsor's protocol ID: EN3835-226
Acronym: APHRODITE
Status last verified: Mar 2025
First submitted: 9 Jun 2022
Last updated: 7 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: APHRODITE-1: A Phase 2, Open Label, Self-Controlled Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks in Adult Females
ClinicalTrials.gov ID: NCT05419505
Acronym / sponsor ID: APHRODITE / EN3835-226
Conditions: Edematous Fibrosclerotic Panniculopathy, Cellulite
Keywords: Collagenase Clostridium Histolyticum, collagenase clostridium histolyticum-aaes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
Study start: 15 Jun 2022 (actual)
Primary completion: 3 Jan 2023 (actual)
Study completion: 21 Jun 2023 (actual)
First posted: 15 Jun 2022 (actual)
Results: Posted 7 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
Cohort 1: CCH-aaes Dose Evaluation	Experimental	Drug: CCH-aaesParticipants will be administered CCH-aaes at different doses. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
Cohort 2: CCH-aaes Concentration Evaluation	Experimental	Drug: CCH-aaesParticipants will be administered CCH-aaes at different concentrations. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
Cohort 3: CCH-aaes Injection Depth Evaluation	Experimental	Drug: CCH-aaesParticipants will be administered CCH-aaes using different injection depths. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
Cohort 4: CCH-aaes Injection Method Evaluation	Experimental	Drug: CCH-aaesParticipants will be administered CCH-aaes using different injection methods. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
Cohort 5: CCH-aaes and Diluent Additive Evaluation	Experimental	Drug: CCH-aaesParticipants will be administered CCH-aaes and diluent additive. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation	Experimental	Drug: CCH-aaesParticipants will be administered CCH-aaes using a different treatment schedule and different doses and concentrations. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
Cohort 7: CCH-aaes and Antifibrinolytic Agent	Experimental	Drug: CCH-aaes, Drug: Antifibrinolytic AgentParticipants will be administered CCH-aaes and an antifibrinolytic agent. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Have a body mass index of 18 to <32 kilograms (kg)/meter (m)^2 and intends to maintain stable body weight during the study.
Have both buttocks with moderate or severe cellulite as reported by the investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
Have a Hexsel Cellulite Severity Scale (CSS) Total Score of ≤12.
Has a Fitzpatrick Skin Type of I-IV
Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of participation in the study.

Key exclusion criteria (23 listed)

Has systemic conditions (coagulation disorders, skin pigmentation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation.
Is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study.
Has any local (in the areas to be treated) conditions (thrombosis, post-thrombosis syndrome, vascular disorder, inflammation, active infection, active cutaneous alteration, tattoo or mole) that restricts study participation.
Requires antiplatelet medication, anticoagulants, or non-steroidal anti-inflammatory drugs during the study.
Any medications, supplements, or foods that have, or have been reported to have anticoagulant effects within 14 days of treatment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CCH-aaesAlso: Collagenase clostridium histolyticum-aaes, QWO®Administered by subcutaneous injection.	Drug	Cohort 1: CCH-aaes Dose Evaluation, Cohort 2: CCH-aaes Concentration Evaluation, Cohort 3: CCH-aaes Injection Depth Evaluation, Cohort 4: CCH-aaes Injection Method Evaluation, Cohort 5: CCH-aaes and Diluent Additive Evaluation, Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation, Cohort 7: CCH-aaes and Antifibrinolytic Agent
Antifibrinolytic AgentSelf-administered by participants enrolled in Cohort 7.	Drug	Cohort 7: CCH-aaes and Antifibrinolytic Agent

Primary outcome

Percentage of Participants With at Least 1-Level Lower Score 3 to 5 Days After Initial CCH-aaes Injection, as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection
Time frame: 3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control)
The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcomes. The investigator compared the bruising of the left (test) buttock to the right (control) buttock. Responders were participants whose left buttock/test side demonstrated at least a 1-level lower IABSS score versus the right buttock/control side. Percentages are based on the number of participants with an assessment at specified timepoint.

3 secondary outcomes

Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS
Time frame: Follow-up 1, 2, 3, and 4 after CCH-aaes injection of left buttock (test) and right buttock (control)
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
Time frame: Day 22 and Day 43 for Cohorts 1 to 5, Day 43 for Cohort 6, Day 22, Day 43, and Day 64 for Cohort 7, and Day 90, Day 135, and Day 180 for all cohorts
Percentage of Participants With Injection Site Reactions
Time frame: From Day 1 (after dose) through Day 180

Results and safety

Results posted to the registry on 7 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: CCH-aaes Dose Evaluation	22	19
Cohort 2: CCH-aaes Concentration Evaluation	14	11
Cohort 3: CCH-aaes Injection Depth Evaluation	5	5
Cohort 4: CCH-aaes Injection Method Evaluation	7	6
Cohort 5: CCH-aaes and Diluent Additive Evaluation	10	9
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation	19	17
Cohort 7a: CCH-aaes and Antifibrinolytic Agent	7	6
Cohort 7b: CCH-aaes and Antifibrinolytic Agent	7	6

Primary outcome: Percentage of Participants With at Least 1-Level Lower Score 3 to 5 Days After Initial CCH-aaes Injection, as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection

Time frame: 3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cohort 1: CCH-aaes Dose Evaluation n = 21	Cohort 2: CCH-aaes Concentration Evaluation n = 12	Cohort 3: CCH-aaes Injection Depth Evaluation n = 5	Cohort 4: CCH-aaes Injection Method Evaluation n = 6	Cohort 5: CCH-aaes and Diluent Additive Evaluation n = 9	Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation n = 19	Cohort 7a: CCH-aaes and Antifibrinolytic Agent n = 6	Cohort 7b: CCH-aaes and Antifibrinolytic Agent n = 6
Value	90.5 (69.62 to 98.83)	25.0 (5.49 to 57.19)	20.0 (0.51 to 71.64)	33.3 (4.33 to 77.72)	44.4 (13.70 to 78.80)	63.2 (38.36 to 83.71)	33.3 (4.33 to 77.72)	33.3 (4.33 to 77.72)

Population analysed: All participants who received at least 1 injection of CCH-aaes and who had at least 1 valid IABSS assessment after an injection of CCH-aaes at specified timepoint. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 (after dose) through Day 180. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: CCH-aaes Dose Evaluation-Test (ISR)	0 of 0	22 of 22 (100%)	0
Cohort 1: CCH-aaes Dose Evaluation-Control (ISR)	0 of 0	22 of 22 (100%)	0
Cohort 2: CCH-aaes Concentration Evaluation-Test (ISR)	0 of 0	13 of 14 (92.9%)	0
Cohort 2: CCH-aaes Concentration Evaluation -Control (ISR)	0 of 0	13 of 14 (92.9%)	0
Cohort 3: CCH-aaes Injection Depth Evaluation-Test (ISR)	0 of 0	5 of 5 (100%)	0
Cohort 3: CCH-aaes Injection Depth Evaluation-Control (ISR)	0 of 0	5 of 5 (100%)	0
Cohort 4: CCH-aaes Injection Method Evaluation-Test (ISR)	0 of 0	7 of 7 (100%)	0
Cohort 4: CCH-aaes Injection Method Evaluation-Control (ISR)	0 of 0	7 of 7 (100%)	0
Cohort 5: CCH-aaes and Diluent Additive Evaluation-Test (ISR)	0 of 0	10 of 10 (100%)	0
Cohort 5: CCH-aaes and Diluent Additive Evaluation-Control (ISR)	0 of 0	10 of 10 (100%)	0
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation -Test (ISR)	0 of 0	19 of 19 (100%)	0
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation-Control (ISR)	0 of 0	19 of 19 (100%)	0
Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Test (ISR)	0 of 0	7 of 7 (100%)	0
Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Control (ISR)	0 of 0	6 of 7 (85.7%)	0
Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Test (ISR)	0 of 0	7 of 7 (100%)	0
Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Control (ISR)	0 of 0	7 of 7 (100%)	0
Cohort 1: Systemic/Non-ISR AEs

Limitations and caveats (from the sponsor): The study was halted before the predetermined sample size was enrolled, therefore, was not adequately powered to draw conclusions or to make comparisons between cohorts.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Hernandez study director

Endo USA Inc., a Keenova Therapeutics Company

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With at Least 1-Level Lower Score 3 to 5 Days After Initial CCH-aaes Injection, as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection (time frame: 3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05419505.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.