Edematous Fibrosclerotic Panniculopathy (EFP)Phase 4MOBINCT04677712
Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite
A Phase 4 study testing CCH-aaes, Compression and Cold Packs in people with Edematous Fibrosclerotic Panniculopathy (EFP) and Cellulite, run by Endo USA Inc., a Keenova Therapeutics Company at 8 sites in United States.
Trial summary
This study will investigate treatments that may mitigate bruising after QWO™ (Collagenase clostridium histolyticum [CCH]-aaes) treatment of cellulite in the buttocks. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Edematous Fibrosclerotic Panniculopathy (EFP), Cellulite
- What is being tested?
- CCH-aaes, Compression and Cold Packs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 8 sitesUnited States
- Study dates
- 28 Dec 2020to 2 Sep 2021
- Phase
- Phase 4
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have both buttocks with:
- Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) score of 3 (moderate) as reported by the Investigator, and
- 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 body mass index 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.
Who cannot join
- 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.
- Antiplatelet medication (clopidogrel [Plavix®] including aspirin at any dose within 14 days of treatment.
- Anticoagulants, such as warfarin (Coumadin®); heparin analogues within 14 days of treatment.
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- Non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen (Motrin®, Advil®) and naproxen (Aleve®) 7 days before the study.
- Any medications or food that have or have been reported to have anticoagulant effects within 14 days of treatment.
- 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 investigational drug or treatment within 30 days prior to injection of CCH-aaes.
- Has a history of hypersensitivity or allergy to collagenase or any other excipient 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 contraindications to PDL a. exposure to Accutane® (isotretinoin) within 6 months of CCH-aaes treatment.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Endo Clinical Trial Site #8
Boston, Massachusetts, 02114
Endo Clinical Trial Site #5
Chicago, Illinois, 60611
Endo Clinical Trial Site #6
Fort Collins, Colorado, 80525
Endo Clinical Trial Site #4
Nashville, Tennessee, 37203
Endo Clinical Trial Site #2
Sacramento, California, 95816
Endo Clinical Trial Site #7
San Diego, California, 92122
Endo Clinical Trial Site #3
Scottsdale, Arizona, 85255
Endo Clinical Trial Site #1
Shreveport, Louisiana, 71105
About this study
Official title: MOBI: A Phase 4, Open-Label Study to Assess Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite in Adult Females
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.
- Being tested
- CCH-aaes, Compression, Cold Packs, Arnica Gel, INhance®
- Keywords
- Bruising mitigation, CCH-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 QWO™
Participants were administered CCH-aaes by subcutaneous injection to both buttocks.
CompressionOther
Participants used a compression garment on both buttocks following subcutaneous CCH-aaes injections.
Cold PacksOther
Participants used cold packs applied to the right buttock for 5-10 minutes immediately after subcutaneous CCH-aaes injections.
Arnica GelDrug
Participants used Arnica Gel Patches (Arnica montana 50% and Ledum palustre) immediately after the CCH-aaes injection to the right buttock.
INhance®Drug
Participants used INhance Post-injection Serum topically immediately after the CCH-aaes injection to the right buttock.
PDLOther
Investigators applied one treatment with PDL to the right buttock between days 1-7 after injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: CCH-aaes | Active comparator | CCH-aaes was administered without mitigation treatment (control group). Receives: Drug: CCH-aaes |
| Cohort 2: CCH-aaes + Compression Garment | Active comparator | CCH-aaes was administered with compression garment. Receives: Other: Compression |
| Cohort 3: CCH-aaes + Instant Cold Packs | Active comparator | CCH-aaes was administered with instant cold packs. Receives: Other: Cold Packs |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Active comparator | CCH-aaes was administered with arnica gel patches (OcuMend). Receives: Drug: Arnica Gel |
| Cohort 5:CCH-aaes + INhance Post-Injection Serum with TriHex Technology® | Active comparator | CCH-aaes was administered with INhance Post-Injection Serum with TriHex Technology® Receives: Drug: INhance® |
| Cohort 6: CCH-aaes + Pulse Dye Laser Treatment (PDL) | Active comparator | CCH-aaes was administered with PDL. Receives: Other: PDL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 4 (3 days after CCH-aaes injection)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start28 Dec 2020
- Primary completion26 Jun 2021
- Study completion2 Sep 2021
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 Panniculopathy (EFP)Studies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Investigators
- Medical Affairs, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677712
- Sponsor's protocol ID
- EN3835-401
- Acronym
- MOBI
- Status last verified
- Aug 2023
- First submitted
- 17 Dec 2020
- Last updated
- 21 Aug 2023
- 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 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOBI: A Phase 4, Open-Label Study to Assess Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite in Adult Females
- ClinicalTrials.gov ID
- NCT04677712
- Acronym / sponsor ID
- MOBI / EN3835-401
- Keywords
- Bruising mitigation, CCH-aaes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- 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.
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 26 Jun 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Posted 21 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: CCH-aaes | Active comparator | Drug: CCH-aaesCCH-aaes was administered without mitigation treatment (control group). |
| Cohort 2: CCH-aaes + Compression Garment | Active comparator | Other: CompressionCCH-aaes was administered with compression garment. |
| Cohort 3: CCH-aaes + Instant Cold Packs | Active comparator | Other: Cold PacksCCH-aaes was administered with instant cold packs. |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Active comparator | Drug: Arnica GelCCH-aaes was administered with arnica gel patches (OcuMend). |
| Cohort 5:CCH-aaes + INhance Post-Injection Serum with TriHex Technology® | Active comparator | Drug: INhance®CCH-aaes was administered with INhance Post-Injection Serum with TriHex Technology® |
| Cohort 6: CCH-aaes + Pulse Dye Laser Treatment (PDL) | Active comparator | Other: PDLCCH-aaes was administered with PDL. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Have both buttocks with:
- Have a body mass index 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 (19 listed)
- 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.
- Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
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: QWO™Participants were administered CCH-aaes by subcutaneous injection to both buttocks. | Drug | Cohort 1: CCH-aaes |
| CompressionParticipants used a compression garment on both buttocks following subcutaneous CCH-aaes injections. | Other | Cohort 2: CCH-aaes + Compression Garment |
| Cold PacksParticipants used cold packs applied to the right buttock for 5-10 minutes immediately after subcutaneous CCH-aaes injections. | Other | Cohort 3: CCH-aaes + Instant Cold Packs |
| Arnica GelParticipants used Arnica Gel Patches (Arnica montana 50% and Ledum palustre) immediately after the CCH-aaes injection to the right buttock. | Drug | Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) |
| INhance®Participants used INhance Post-injection Serum topically immediately after the CCH-aaes injection to the right buttock. | Drug | Cohort 5:CCH-aaes + INhance Post-Injection Serum with TriHex Technology® |
| PDLInvestigators applied one treatment with PDL to the right buttock between days 1-7 after injection. | Other | Cohort 6: CCH-aaes + Pulse Dye Laser Treatment (PDL) |
Primary outcome
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
Time frame: 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.
7 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)
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)
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
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
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
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
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
Time frame: Day 22
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- 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.
Medical Affairs study director
Endo USA Inc., a Keenova Therapeutics Company
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CCH-aaes, Compression and Cold Packs in people with Edematous Fibrosclerotic Panniculopathy (EFP) and Cellulite, run by Endo USA Inc., a Keenova Therapeutics Company at 8 sites in United States.
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 7 inclusion and 19 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 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 21 Aug 2023). 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?
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 (time frame: Day 4 (3 days after CCH-aaes injection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2023.