CellulitePhase 2NCT04209530
Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Women
A Phase 2 study testing EN3835 in people with Cellulite and Edematous Fibrosclerotic Panniculopathy (EFP), run by Endo USA Inc., a Keenova Therapeutics Company at 1 site in United States.
Trial summary
This is a single center, open-label, Phase 2a study to assess the photonumeric scale, morphological, and histopathological changes associated with Collagenase Clostridium Histolyticum (CCH) in adult women with moderate or severe Edematous Fibrosclerotic Panniculopathy (EFP). 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
- Cellulite, Edematous Fibrosclerotic Panniculopathy (EFP)
- What is being tested?
- EN3835
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2019to 5 Oct 2020
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have both buttocks or both posterolateral thighs with:
- A score of 3 or 4 (moderate or severe) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
- A Hexsel Cellulite Severity Scale (CSS) Subsection A "Number of Evident Depressions" score of >0, and Subsection B "Depth of Depressions" score of 2 )medium depth depression) or 3 (deep depressions)..
- Have a minimum of 2 well defined and isolated cellulite dimples.
- Be willing to apply sunscreen to the treatment area before each exposure to the sun for the duration of the study (from the Screening Visit through the Day 251/Early Termination Visit).
- Be judged to be in good health.
- Have a negative pregnancy test.
- Be willing and able to cooperate with the requirements of the study.
Who cannot join
- Is from a vulnerable population, as defined by the United States (US) Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.
- Has systemic conditions (coagulation disorders, malignancy, keloidal scar, abnormal wound healing) that restricts study participation.
- Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
- Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin.
- Requires anticoagulant or antiplatelet medication during the study.
Show all 17Show fewer
- Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
- Has used any form of artificial tanning (sprays, lotions, tanning booth, etc) within the 30 days prior to the first dose of study treatment or plans to use any form of artificial tanning during the study (through the Day 251/Early Termination Visit).
- Has a positive HIV test and/or a positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) test at screening.
- Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment.
- Has a history of keloids, hypertrophied scars, and/or other complications following biopsy.
- Has any contraindications for MRI(implant containing metal, internal metallic object, permanent cosmetics/make-up, claustrophobia, syncope, low blood pressure, epilepsy, asthma, sickle cell disease) that restricts study participation.
- Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH in a previous investigational study for cellulite.
- Has previously received treatment with CCH in this clinical study.
- Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit.
- Is pregnant and/or is providing breast milk or plans to become pregnant and/or to provide breast milk during the course of the study.
- Has any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Endo Clinical Trial Site #1
Coral Gables, Florida, 33146
About this study
Official title: A Phase 2a, Open Label Study to Assess the Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Females Using Photonumeric Scales, Magnetic Resonance Imaging and Histopathology
This is a single center, open-label, Phase 2a study to assess the photonumeric scale, morphological, and histopathological changes associated with Collagenase Clostridium Histolyticum (CCH) in adult women with moderate or severe Edematous Fibrosclerotic Panniculopathy (EFP).
- Being tested
- EN3835
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EN3835Drug
Collagenase Clostridium Histolyticum (CCH)
| Study group | Role | What they receive |
|---|---|---|
| Buttock & Posterolateral Thigh | Experimental | EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum) Receives: Drug: EN3835 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change From Baseline (Screening) in PR-PCSS
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (None) to "4" (Severe) from a patient's perspective
Measured: Day 71
Secondary outcomes (4)
The Change From Baseline (Screening) in CR-PCSS
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (None) to "4" (Severe) from a clinician's perspective
Measured: Day 22, Day 43 and Day 71
The Change From Baseline (Screening) in Hexsel Cellulite Severity Scale (CSS)
Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite, each feature is evaluated on a 4-point scale from "0" (Low) to "3" (High)
Measured: Day 22, Day 43 and Day 71
MRI Before and After CCH Treatment
Magnetic Resonance Imaging (MRI) of cellulite before and after CCH treatment
Measured: Day 71
Histopathology Before and After CCH Treatment
Histopathology of biopsies defined by the observation of the biopsied specimen by a trained Pathologist
Measured: Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start20 Nov 2019
- Primary completion23 Jul 2020
- Study completion5 Oct 2020
Why it stopped: Study terminated due to COVID-19 impact
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 CelluliteStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashley Dayoub, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209530
- Sponsor's protocol ID
- EN3835-212
- Status last verified
- Nov 2020
- First submitted
- 11 Dec 2019
- Last updated
- 7 Oct 2021
- 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 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open Label Study to Assess the Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Females Using Photonumeric Scales, Magnetic Resonance Imaging and Histopathology
- ClinicalTrials.gov ID
- NCT04209530
- Acronym / sponsor ID
- EN3835-212
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to COVID-19 impact
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 23 Jul 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Posted 7 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center, open-label, Phase 2a study to assess the photonumeric scale, morphological, and histopathological changes associated with Collagenase Clostridium Histolyticum (CCH) in adult women with moderate or severe Edematous Fibrosclerotic Panniculopathy (EFP).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Buttock & Posterolateral Thigh | Experimental | Drug: EN3835EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Have both buttocks or both posterolateral thighs with:
- Have a minimum of 2 well defined and isolated cellulite dimples.
- Be willing to apply sunscreen to the treatment area before each exposure to the sun for the duration of the study (from the Screening Visit through the Day 251/Early Termination Visit).
- Be judged to be in good health.
- Have a negative pregnancy test.
Key exclusion criteria (17 listed)
- Is from a vulnerable population, as defined by the United States (US) Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.
- Has systemic conditions (coagulation disorders, malignancy, keloidal scar, abnormal wound healing) that restricts study participation.
- Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
- Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin.
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 |
|---|---|---|
| EN3835Collagenase Clostridium Histolyticum (CCH) | Drug | Buttock & Posterolateral Thigh |
Primary outcome
The Change From Baseline (Screening) in PR-PCSS
Time frame: Day 71
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (None) to "4" (Severe) from a patient's perspective
4 secondary outcomes
The Change From Baseline (Screening) in CR-PCSS
Time frame: Day 22, Day 43 and Day 71
The Change From Baseline (Screening) in Hexsel Cellulite Severity Scale (CSS)
Time frame: Day 22, Day 43 and Day 71
MRI Before and After CCH Treatment
Time frame: Day 71
Histopathology Before and After CCH Treatment
Time frame: Day 71
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Ashley Dayoub study director
Endo USA Inc., a Keenova Therapeutics Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EN3835 in people with Cellulite and Edematous Fibrosclerotic Panniculopathy (EFP), run by Endo USA Inc., a Keenova Therapeutics Company at 1 site 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 8 inclusion and 17 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: stopped early, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Oct 2021). 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?
The Change From Baseline (Screening) in PR-PCSS (time frame: Day 71). 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 7 Oct 2021.