CelluliteNCT05249257
Durability and Safety of CCH With Two Different Injection Techniques in Cellulite With Laxity
An observational study of Cellulite and Laxity; Skin, run by Endo USA Inc., a Keenova Therapeutics Company at 3 sites in United States.
Trial summary
All participants who completed the EN3835-224 study will be invited to participate in this observational study to evaluate long term durability of response and safety. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Cellulite, Laxity; Skin, Edematous Fibrosclerotic Panniculopathy
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jan 2022to 12 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years
- Women only
- No healthy volunteers
- Adult
Study population: The Safety Population is defined as all participants who meet the inclusion/exclusion criteria at Day 360. All Safety analyses will be based on this population. The Full Analysis Set (FAS) is defined as all participants in the Safety Population who have at least 1 I-GAIS assessment. All efficacy analyses will be based on this population.
Who may be able to join
- Have participated in and completed study EN3835-224 (parent study).
- Be willing and able to cooperate with the requirements of the study.
Who cannot join
- Has received any collagenase treatments (eg, Santyl® Ointment) at any time since
- Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-224 study since the completion of that study.
- Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Endo Clinical Trial Site #2
Coral Gables, Florida, 33146
Endo Clinical Trial Site #3
Metairie, Louisiana, 70006
Endo Clinical Trial Site #1
New York, New York, 10021
About this study
Official title: A Phase 2, Multicenter, Observational Study to Assess the Durability and Safety of Collagenase Clostridium Histolyticum Injected With GRID Technique in Buttocks or Thigh Cellulite With Laxity in Adult Females
All participants who completed the EN3835-224 study will be invited to participate in this observational study to evaluate long term durability of response and safety.
- Medical subject headings
- Cellulite, Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No Treatment - previously treated in parent study | Participants who completed the parent study EN3835-224 (NCT04580303) will be eligible for this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to "-3" (very much worse) to determine the degree of improvement of the treated areas
Measured: Day 360
Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to "-3" (very much worse) to determine the degree of improvement of the treated areas
Measured: Day 540
Secondary outcomes (3)
I-GAIS ratings
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to a "-3" (very much worse) to determine the degree of improvement of the treated areas.
Measured: Day 360 and Day 540
Proportion of 1-level responders (+1 or better score) on the S-GAIS for either buttock or either thigh
Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-level scale ranging from "+3" (very much improved) to a "-3" (very much worse).
Measured: Day 360 and Day 540
Change from Day 1 (pre-treatment) of the parent study and each study visit in Subsection D of the Hexsel CSS
Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite using a 4-point scale ranging from "0" (low) to "3" (high).
Measured: Day 360 and Day 540
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start25 Jan 2022
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Chajko, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249257
- Sponsor's protocol ID
- EN3835-225
- Status last verified
- Jan 2023
- First submitted
- 25 Jan 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Observational Study to Assess the Durability and Safety of Collagenase Clostridium Histolyticum Injected With GRID Technique in Buttocks or Thigh Cellulite With Laxity in Adult Females
- ClinicalTrials.gov ID
- NCT05249257
- Acronym / sponsor ID
- EN3835-225
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All participants who completed the EN3835-224 study will be invited to participate in this observational study to evaluate long term durability of response and safety.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Treatment - previously treated in parent study | – | –Participants who completed the parent study EN3835-224 (NCT04580303) will be eligible for this study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The Safety Population is defined as all participants who meet the inclusion/exclusion criteria at Day 360. All Safety analyses will be based on this population. The Full Analysis Set (FAS) is defined as all participants in the Safety Population who have at least 1 I-GAIS assessment. All efficacy analyses will be based on this population.
Key inclusion criteria (2 listed)
- Have participated in and completed study EN3835-224 (parent study).
- Be willing and able to cooperate with the requirements of the study.
Key exclusion criteria (3 listed)
- Has received any collagenase treatments (eg, Santyl® Ointment) at any time since
- Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-224 study since the completion of that study.
- Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh
Time frame: Day 360
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to "-3" (very much worse) to determine the degree of improvement of the treated areas
Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh
Time frame: Day 540
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to "-3" (very much worse) to determine the degree of improvement of the treated areas
3 secondary outcomes
I-GAIS ratings
Time frame: Day 360 and Day 540
Proportion of 1-level responders (+1 or better score) on the S-GAIS for either buttock or either thigh
Time frame: Day 360 and Day 540
Change from Day 1 (pre-treatment) of the parent study and each study visit in Subsection D of the Hexsel CSS
Time frame: Day 360 and Day 540
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: No
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Thigh Cellulite
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Cellulite
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.
Karen Chajko study director
Endo USA Inc., a Keenova Therapeutics Company
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cellulite and Laxity; Skin, run by Endo USA Inc., a Keenova Therapeutics Company at 3 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 2 inclusion and 3 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 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh (time frame: Day 360). The study lists 2 primary outcomes in all. 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 19 Jan 2023.