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Edematous Fibrosclerotic Panniculopathy (Cellulite)Phase 3RELEASE-2NCT03446781

Effectiveness and Safety of EN3835 in the Treatment of Cellulite in Women

A Phase 3 study testing EN3835 in people with Edematous Fibrosclerotic Panniculopathy (Cellulite), run by Endo USA Inc., a Keenova Therapeutics Company at 25 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

Subjects will be screened for study eligibility within 14 days prior to enrolling in this study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of cellulite as independently assessed by the subject using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) and by… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
EN3835
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
422 participants
Where
25 sitesUnited States
Study dates
8 Feb 2018to 26 Sep 2018
Phase
Phase 3
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign and date an informed consent agreement
  • Be a female ≥18 years of age
  • At Screening visit, have 2 bilateral buttocks with each buttock having:
  • a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and
  • a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS)
  • At Day 1 visit, have 2 bilateral buttocks with each buttock having:
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  • a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and
  • a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS)
  • Be willing to apply sunscreen to the buttocks before each exposure to the sun while participating in the study (ie, Screening through end of study)
  • Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at Screening
  • Have a negative serum pregnancy test at Screening and a negative urine pregnancy test before injection of study drug and be using a stable and effective contraception method (eg, abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives, or double barrier method) for at least 1 menstrual cycle prior to study enrollment and for the duration of the study; or be menopausal defined as 12 months of amenorrhea in the absence of other biological or physiological causes, as determined by the Investigator; or post-menopausal for at least 1 year; or be surgically sterile
  • Be willing and able to cooperate with the requirements of the study
  • Be able to read, complete and understand the patient-reported outcomes rating instruments in English

Who cannot join

  • Has any of the following systemic conditions:
  • Coagulation disorder
  • Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there has been no recurrence in at least 5 years
  • History of keloidal scarring or abnormal wound healing
  • Concurrent diseases or conditions that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. Any questions about concurrent diseases should be discussed with the Medical Monitor
  • Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values
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  • Has any of the following local conditions in the areas to be treated:
  • History of lower extremity thrombosis or post-thrombosis syndrome
  • Vascular disorder (eg, varicose veins, telangiectasia) in area to be treated
  • Inflammation or active infection
  • Severe skin laxity, flaccidity, and/or sagging
  • Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer
  • Has a tattoo and/or a mole located within 2 cm of the site of injection
  • Requires the following concomitant medications before or during participation in the trial:
  • Anticoagulant or antiplatelet medication or has received anticoagulant or antiplatelet medication (except for ≤150 mg aspirin daily) within 7 days before injection of study drug
  • Has used any of the following for the treatment of EFP on a buttock within the timelines identified below or intends to use any of the following at any time during the course of the study:
  • Liposuction in a buttock during the 12-month period before injection of study drug
  • Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; buttock implant treatment; cryolipolysis; or surgery (including subcision and/or powered subcision) within a buttock during the 12-month period before injection of study drug
  • Any investigational treatment for EFP on a buttock during the 12-month period before the injection of study drug
  • Endermologie or similar treatments within a buttock during the 6-month period before injection of study drug
  • Massage therapy within a buttock during the 3-month period before injection of study drug
  • Creams (eg, Celluvera™, TriLastin®) and/or home therapies to prevent or mitigate EFP within a buttock during the 2-week period before injection of study drug
  • Is presently nursing or providing breast milk
  • Intends to become pregnant during the study
  • Intends to initiate an intensive sport or exercise program during the study
  • Intends to initiate a weight reduction program during the study
  • Intends to use tanning spray or tanning booths during the study
  • Has received an investigational drug or treatment within 30 days before injection of study drug
  • Has a known systemic allergy to collagenase or any other excipient of study drug
  • Has received any collagenase treatments at any time prior to treatment
  • Was a subject in a previous cellulite clinical trial of CCH: AUX-CC-830, AUX-CC-831, EN3835-102, EN3835-104, EN3835-201, EN3835-202, and/or EN3835-205
  • Any other condition(s) that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Endo Clinical Trial Site #20

    Austin, Texas, 78759

  • Endo Clinical Trial Site #21

    Beaumont, Texas, 77701

  • Endo Clinical Trial Site #3

    Beverly Hills, California, 90210

  • Endo Clinical Trial Site #11

    Carmel, Indiana, 46032

  • Endo Clinical Trial Site #18

    Cincinnati, Ohio, 45212

  • Endo Clinical Trial Site #8

    Coral Gables, Florida, 33146

  • Endo Clinical Trial Site #16

    East Setauket, New York, 11733

  • Endo Clinical Trial Site #1

    Glendale, Arizona, 85308

  • Endo Clinical Trial Site #7

    Greenwood Village, Colorado, 80111

  • Endo Clinical Trial Site #22

    Houston, Texas, 77494

  • Endo Clinical Trial Site #25

    Lynchburg, Virginia, 24501

  • Endo Clinical Trial Site #12

    Metairie, Louisiana, 70006

  • Endo Clinical Trial Site #9

    Miami, Florida, 33137

  • Endo Clinical Trial Site #15

    Montclair, New Jersey, 07042

  • Endo Clinical Trial Site #4

    Murrieta, California, 92562

  • Endo Clinical Trial Site #10

    Nampa, Idaho, 83651

  • Endo Clinical Trial Site #19

    Nashville, Tennessee, 37215

  • Endo Clinical Trial Site #13

    New Orleans, Louisiana, 70124

  • Endo Clinical Trial Site #17

    New York, New York, 10016

  • Endo Clinical Trial Site #5

    Newport Beach, California, 92663

  • Endo Clinical Trial Site #2

    North Little Rock, Arkansas, 72116

  • Endo Clinical Trial Site #24

    Salt Lake City, Utah, 84101

  • Endo Clinical Trial Site #23

    San Antonio, Texas, 78229

  • Endo Clinical Trial Site #6

    San Diego, California, 92121

  • Endo Clinical Trial Site #14

    Warren, Michigan, 48088

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of EN3835 In The Treatment Of Edematous Fibrosclerotic Panniculopathy (Cellulite)

Subjects will be screened for study eligibility within 14 days prior to enrolling in this study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of cellulite as independently assessed by the subject using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) and by the Investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) will be eligible. The eligibility of the buttocks will be confirmed on Day 1. Once the eligibility of the buttocks is confirmed, subjects will be randomly assigned to a treatment group (EN3835 0.84 mg per buttock or placebo) in a 1:1 ratio within an investigational site. Each subject will receive a treatment course which consists of up to 3 treatment visits (sessions), separated by 21 days (ie, Days 1, 22, and 43). Each treatment visit will consist of 12 injections (0.3 mL per injection of EN3835 0.07 mg/injection or placebo; 0.84 mg in 3.6 mL per buttock) in each of the two buttocks for a total volume of 7.2 mL (1.68 mg). Selection of dimples to be treated in the buttocks will be at the discretion of the Investigator. End of study will occur at study day 71.

Being tested
EN3835, Placebo
Medical subject headings
Cellulite

What participants receive

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

  • EN3835Biological

    Collagenase clostridium histolyticum

  • PlaceboBiological

    Placebo

Study groups in NCT03446781
Study groupRoleWhat they receive
EN3835 ActiveActive comparatorEN3835 0.84mg (Collagenase Clostridium Histolyticum)
Receives: Biological: EN3835
PlaceboPlacebo comparatorPlacebo
Receives: Biological: Placebo

What is being measured

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

  1. 2-level Composite Responders for the Target Buttock

    Proportion of 2-level Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) / Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) composite responders in the target buttock at Day 71. CR-PCSS and PR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is defined as a participant with improvement from baseline of at least 2-levels of severity in the CR-PCSS and an improvement from baseline of at least 2-levels of severity in the PR-PCSS of the target buttock. A participant who missed one or two assessments of CR-PCSS and PR-PCSS at Day 71 was defined as a non-responder.

    Measured: Day 71

Secondary outcomes (10)

  1. 1-level PR-PCSS Responders of the Target Buttock

    Improvement in cellulite severity of the Target Buttock from baseline of at least 1-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS). PR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).

    Measured: Day 71

  2. 2-level PR-PCSS Responders of the Target Buttock

    Improvement in cellulite severity of the Target Buttock from baseline of at least 2-levels of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS). PR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).

    Measured: Day 71

  3. 1-level Composite Responders of the Target Buttock

    Improvement in cellulite severity of the Target Buttock from baseline of at least 1-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) / Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS). PR-PCSS and CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).

    Measured: Day 71

  4. 2-level Composite Responders of the Non-target Buttock

    Improvement in cellulite severity of the Non-target Buttock from baseline of at least 2-levels of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) / Clinician -Reported Photonumeric Cellulite Severity Scale (CR-PCSS). PR-PCSS and CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).

    Measured: Day 71

  5. 1-level SSRS Responders

    Subject Self-Rating Scale (SSRS) is a measure that assesses participant satisfaction with appearance in association with cellulite on the buttocks using whole numbers on a 7-level scale that ranges from "0" (Extremely Dissatisfied) to "6" (Extremely Satisfied). A 1-level SSRS responder is defined as a participant who is at least slightly satisfied (Slightly Satisfied [4], Very Satisfied [5], or Extremely Satisfied [6]) with the appearance of the cellulite on her buttocks at Day 71.

    Measured: Day 71

  6. Change From Baseline in PR-CIS Total Score

    Patient-Reported Cellulite Impact Scale (PR-CIS) is a 6-item static questionnaire, each item is answered by a participant on a 11-level numerical rating scale that ranges from "0" (Not at all) to "10" (Extremely). The PR-CIS total score is the sum of individual item scores and can range from "0" to "60" with higher numbers reflecting a more negative impact from the cellulite. A responder is defined as a participant with a reduction in the PR-CIS total score of at least 12 from baseline at evaluation time point. A negative change from baseline indicates an improvement in cellulite severity.

    Measured: Day 71

  7. 1-level S-GAIS Responders of Target Buttock

    Subject Global Aesthetic Improvement Scale (S-GAIS) is a measure that assesses participant rating of cellulite appearance after treatment. This scale has 7-levels ranging from "+3" (Very Much Improved) to "-3" (Very Much Worse). Responders are defined as participants with ≥1-level improvement (Improved, Much Improved or Very Improved) in S-GAIS assessment of the Target Buttock.

    Measured: Day 71

  8. 2-level S-GAIS Responders of Target Buttock

    Subject Global Aesthetic Improvement Scale (S-GAIS) is a measure that assesses participant rating of cellulite appearance after treatment. This scale has 7-levels ranging from "+3" (Very Much Improved) to "-3" (Very Much Worse). Responders are defined as participants with ≥ 2-level improvement (Much Improved or Very Much Improved) in S-GAIS assessment of the Target Buttock.

    Measured: Day 71

  9. PR-PCSS Rating for the Target and Non-target Buttock by Visit

    The Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level photonumeric scale used by the patient (participant) to assess the severity of the participant's cellulite. The ratings range from "0" (None) to "4" (Severe).

    Measured: Day 71

  10. Subjects Satisfaction With Cellulite Treatment

    A 1-level Subject Satisfaction Responder is defined as a participant who is at least satisfied (Satisfied [+1], or Very Satisfied [+2]) with the appearance of the cellulite on her buttocks at the Day 71 visit. A positive change indicates an improvement in cellulite.

    Measured: Day 71

Timeline

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

  1. First posted27 Feb 2018
  2. Study start8 Feb 2018
  3. Primary completion26 Sep 2018
  4. Study completion26 Sep 2018

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
422 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03446781
Sponsor's protocol ID
EN3835-303
Acronym
RELEASE-2
Status last verified
Sep 2020
First submitted
4 Feb 2018
Last updated
8 Oct 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kaufman-Janette J, Joseph JH, Kaminer MS, Clark J, Fabi SG, Gold MH, Goldman MP, Katz BE, Peddy K, Schlessinger J, Young VL, Davis M, Hurley D, Liu G, McLane MP, Vijayan S, Bass LS. Collagenase Clostridium Histolyticum-aaes for the Treatment of Cellulite in Women: Results From Two Phase 3 Randomized, Placebo-Controlled Trials. Dermatol Surg. 2021 May 1;47(5):649-656. doi: 10.1097/DSS.0000000000002952.

    PubMed 33840781

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EN3835 in people with Edematous Fibrosclerotic Panniculopathy (Cellulite), run by Endo USA Inc., a Keenova Therapeutics Company at 25 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 13 inclusion and 32 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 8 Oct 2020). 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?

2-level Composite Responders for the Target Buttock (time frame: Day 71). 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 NCT03446781, which also lists 1 linked publication.

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 8 Oct 2020.

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