CellulitePhase 4NCT05026216
To Assess the Effectiveness of Multiple Dose, Multiple Concentrations of Qwo, for the Treatment of Mild to Moderate Cellulite.
A Phase 4 study testing Qwo in people with Cellulite, run by DMR Research, PLLC at 1 site in United States.
Trial summary
This is a single center, off-label, multiple dose, multiple injection areas, Phase 4 study to assess the safety and efficacy of multi-dilution CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite
- What is being tested?
- Qwo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2021to 31 Aug 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Subject Inclusion Criteria:
In order to be eligible to participate in the study, at the Screening Visit and on Study Day 1, subjects must:
- Be female and 18-60 years of age at the time of consent.
- Have both buttocks and both posterolateral thighs with:
- A score of 2 or 3 (mild or moderate) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
- A 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) at the Screening Visit only.
- Have a body mass index (BMI) score between 18.0 kg/m2 and 30.0 kg/m2 and intends to maintain stable body weight (:S10% change from the Day 1 Visit weight) throughout the duration of the study (from the Screening Visit through the Day 180/Early Termination Visit).
- Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study (from the Screening Visit through the Day 180/Early Termination Visit).
- Be judged by the investigator to be in good health, based upon the results of a medical history and physical examination,.
- Be of nonchildbearing potential (history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the Screening Visit); or, if of childbearing potential, be nonpregnant, nonlactating, and agree to use effective contraception when with a male partner for the duration of the study. Acceptable forms of contraception include hormonal measures (oral contraceptive pills, contraceptive patch, contraceptive ring, injections, etc), intrauterine devices, double barrier method (condom plus diaphragm, condom or diaphragm plus spermicidal gel or foam), surgical sterilization of the male partner, and abstinence.
- Have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test prior to dosing at each treatment session.
- Be willing and able to comply with all protocol required visits and assessment Be able to read, understand, and independently complete patient reported outcome instruments in English.
- Be able to read, understand, and independently complete patient reported outcome instruments in English.
- Be adequately informed and understand the nature and risks of the study and be able to provide consent as outlined in Section 10.1.3.
Subject Exclusion Criteria
- A subject is ineligible for study participation if, at the Screening Visit or on Day 1, the subject:
- 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 any of the following systemic conditions:
- Coagulation disorder.
- Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there had 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 will be discussed with the Medical Monitor.
- Evidence of clinically significant abnormalities on physical examination.
- Has any of the following local conditions in the areas to be treated (both buttocks and both thighs):
- History of lower extremity thrombosis or post-thrombosis syndrome.
- Vascular disorder (eg, varicose veins, telangiectasia).
- Inflammation or active infection.
- Active cutaneous alteration including rash, eczema, or psoriasis.
- A tattoo or other artificially inflicted body marker.
- Has a mole located within 2 cm of any injection site.
- Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin.
- Has a Hexsel CSS Subsection D "Grade of laxity, flaccidity, or sagging skin" of 2 (moderate draped appearance) or 3 (severe draped appearance).
- Requires anticoagulant or antiplatelet medication during the study or has received anticoagulant or antiplatelet medication (except for :S150 mg aspirin daily) within 7 days before injection of study treatment.
- Has used any of the following for the treatment of EFP on either thigh and either buttock within the timelines identified below or intends to use any of the following at any time during the course of the study:
- Liposuction during the 12-month period before dosing with study treatment.
- Injections (eg, mesotherapy, dermal fillers, biostimulatory fillers); radiofrequency device treatments; laser treatment; buttock and thigh implant treatment; cryolipolysis; or surgery (including subcision and/or powered subcision) during the 12-month period before injection of study treatment.
- Any investigational treatment for EFP on a buttock and thigh during the 12-month period before the injection of study treatment.
- Endermologie or similar treatments during the 6 month period before injection of study treatment.
- Massage therapy during the 3-month period before injection of study treatment. Creams (eg, Celluvera™, TriLastin®) and/or home therapies to prevent or mitigate EFP during the 2-week period before injection of study treatment.
- Has received any collagenase treatments at any time prior to treatment in this study and/or has received previous treatment with EN3835 or CCH for cellulite.
- 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.
- Intends to initiate an intensive sport or exercise program during the study.
- Intends to initiate an intensive weight reduction program during 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.
About this study
Official title: To Assess the Effectiveness of Multiple Dose, Multiple Concentrations of Clostridium Histolyticum-aases, Qwo, for the Treatment of Mild to Moderate Cellulite in Adult Females to the Buttocks and Thighs
This is a single center, off-label, multiple dose, multiple injection areas, Phase 4 study to assess the safety and efficacy of multi-dilution CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP). 5 subjects will be screened and dosed in the buttock and thigh areas using a multi-dilution injection technique.
Qualified subjects (determined by investigator assessment) will receive a single vial of 0.84 mg of CCH to treatment areas (buttocks and thighs) for a total dose of 1.68 mg in both buttocks and both thighs per treatment session × 3 treatment sessions (Day 1, Day 22, and Day 43). Subjects will have follow-up visits at approximately 90 after Day 1.
- Conditions
- Cellulite
- Being tested
- Qwo
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QwoDrug
Collagenase clostridium histolyticum-aaes is a combination of bacterial collagenases AUX-I and AUX-II, in an approximate 1:1 mass ratio, which are isolated and purified from the fermentation of Clostridium histolyticum bacteria. Collagenase AUX-I is a single polypeptide chain consisting of approximately 1000 amino acids. Collagenase AUX-II is a single polypeptide chain consisting of approximately 1000 amino acids.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm study | Experimental | Using CCH-ases on bilateral buttocks and thigh injections. No placebo being used. Receives: Drug: Qwo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With ≥1-point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Buttocks)
The Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale ranging from -3 = very much worse to +3 = very much improved. Participants were considered responders if they had an I-GAIS score of +1 = improved or greater at Day 90.
Measured: Day 90
Number of Participants With ≥1-Point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Thighs)
The Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale ranging from -3 (very much worse) to +3 (very much improved). Responders were defined as subjects with a score of +1 (improved) or greater.
Measured: Day 90
Secondary outcomes (3)
I-GAIS at Multiple Timepoints Buttocks
The Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale ranging from -3 (very much worse) to +3 (very much improved). Responders were defined as subjects with a score of +1 (improved) or greater.
Measured: Days 22, 43, 90
I-GAIS at Multiple Timepoints Thighs
The Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale ranging from -3 (very much worse) to +3 (very much improved). Responders were defined as subjects with a score of +1 (improved) or greater.
Measured: Day 22, Day 43, Day 90
Mean Change From Baseline in Body-Q Appraisal of Cellulite at Day 90
The Body-Q Appraisal of Cellulite is a patient-reported outcome ranging from 11 to 44, with higher scores indicating less bother from cellulite. Change from baseline to Day 90 was calculated for all participants.
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start29 Mar 2021
- Primary completion15 Aug 2021
- Study completion31 Aug 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 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- DMR Research, PLLC
- Sponsor type
- University, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026216
- Sponsor's protocol ID
- DMRR-001
- Status last verified
- May 2026
- First submitted
- 26 Mar 2021
- Last updated
- 28 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Effectiveness of Multiple Dose, Multiple Concentrations of Clostridium Histolyticum-aases, Qwo, for the Treatment of Mild to Moderate Cellulite in Adult Females to the Buttocks and Thighs
- ClinicalTrials.gov ID
- NCT05026216
- Acronym / sponsor ID
- DMRR-001
- Conditions
- Cellulite
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- DMR Research, PLLCUniversity, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Posted 28 May 2026
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, off-label, multiple dose, multiple injection areas, Phase 4 study to assess the safety and efficacy of multi-dilution CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP). 5 subjects will be screened and dosed in the buttock and thigh areas using a multi-dilution injection technique.
Qualified subjects (determined by investigator assessment) will receive a single vial of 0.84 mg of CCH to treatment areas (buttocks and thighs) for a total dose of 1.68 mg in both buttocks and both thighs per treatment session × 3 treatment sessions (Day 1, Day 22, and Day 43). Subjects will have follow-up visits at approximately 90 after Day 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm study | Experimental | Drug: QwoUsing CCH-ases on bilateral buttocks and thigh injections. No placebo being used. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| QwoCollagenase clostridium histolyticum-aaes is a combination of bacterial collagenases AUX-I and AUX-II, in an approximate 1:1 mass ratio, which are isolated and purified from the fermentation of Clostridium histolyticum bacteria. Collagenase AUX-I is a single polypeptide chain consisting of approximately 1000 amino acids. Collagenase AUX-II is a single polypeptide chain consisting of approximately 1000 amino acids. | Drug | Single-arm study |
Primary outcome
Proportion of Subjects With ≥1-point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Buttocks)
Time frame: Day 90
The Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale ranging from -3 = very much worse to +3 = very much improved. Participants were considered responders if they had an I-GAIS score of +1 = improved or greater at Day 90.
Number of Participants With ≥1-Point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Thighs)
Time frame: Day 90
The Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale ranging from -3 (very much worse) to +3 (very much improved). Responders were defined as subjects with a score of +1 (improved) or greater.
3 secondary outcomes
I-GAIS at Multiple Timepoints Buttocks
Time frame: Days 22, 43, 90
I-GAIS at Multiple Timepoints Thighs
Time frame: Day 22, Day 43, Day 90
Mean Change From Baseline in Body-Q Appraisal of Cellulite at Day 90
Time frame: Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cellulite
Not yet recruiting
Pilot Study of Naringenin Beta Carotene Cream for Local Fat Reduction (SCULPT)
Thigh Cellulite
Active, not recruiting
Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Qwo in people with Cellulite, run by DMR Research, PLLC 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?
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 28 May 2026. 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 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 28 May 2026). 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?
Proportion of Subjects With ≥1-point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Buttocks) (time frame: Day 90). 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 28 May 2026.