A Phase 4 interventional study of Qwo in Cellulite, sponsored by DMR Research, PLLC. Completed at 1 site in United States. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by DMR Research, PLLC · Phase 4, Interventional, and Treatment
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.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 5 is below the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →This is the only study on the registry with DMR Research, PLLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subject Inclusion Criteria:
In order to be eligible to participate in the study, at the Screening Visit and on Study Day 1, subjects must:
Have both buttocks and both posterolateral thighs with:
Subject Exclusion Criteria
Has any of the following systemic conditions:
Has any of the following local conditions in the areas to be treated (both buttocks and both thighs):
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Using CCH-ases on bilateral buttocks and thigh injections. No placebo being used.
Drug: Qwo
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.
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.
Time frame: 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.
Time frame: Day 90
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 90
Patients who completed the EN3835-305 real-world study were recruited to participate in the IIR.
| Milestone | Single-arm Study |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
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.
| Participants | Single-arm Study |
|---|---|
| Responders (≥+1) | 3 |
| Non-responders (<+1) | 2 |
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.
| Participants | Single-arm Study |
|---|---|
| Day 22 — Responders (≥+1) | 0 |
| Day 22 — Non-responders (<+1) | 5 |
| Day 43 — Responders (≥+1) | 1 |
| Day 43 — Non-responders (<+1) | 4 |
| Day 90 — Responders (≥+1) | 3 |
| Day 90 — Non-responders (<+1) | 2 |
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.
| Participants | Single-arm Study |
|---|---|
| Responders (≥+1) | 4 |
| Non-responders (<+1) | 1 |
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.
| Participants | Single-arm Study |
|---|---|
| Day 22 — Responders (≥+1) | 3 |
| Day 22 — Non-responders (<+1) | 2 |
| Day 43 — Responders (≥+1) | 2 |
| Day 43 — Non-responders (<+1) | 3 |
| Day 90 — Responders (≥+1) | 4 |
| Day 90 — Non-responders (<+1) | 1 |
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.
| Score (11-44 scale) | Single-arm Study |
|---|---|
| Mean Change From Baseline in Body-Q Appraisal of Cellulite at Day 90 | 11.6 ± 7.6 |
Collected over The following adverse events were reported by each subject post-treatment sessions, Day 1, Day 22 and Day 43.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single-arm Study | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Event | Single-arm Study |
|---|---|
| BruisingSkin and subcutaneous tissue disorders | 5/5 |
| EdemaGeneral disorders | 5/5 |
| Hemosiderin StainingSkin and subcutaneous tissue disorders | 5/5 |
| TendernessGeneral disorders | 5/5 |
| PruritisSkin and subcutaneous tissue disorders | 2/5 |
| Age, Categorical(Participants) | QWO Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | QWO Treatment |
|---|---|
| Female | 5 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | QWO Treatment |
|---|---|
| White/Not-Hispanic | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2021 to primary completion in Aug 2021, 4 months.
Results were first posted in May 2026, 4 years 9 months after primary completion.
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