Phase 4
N=5
To Assess the Effectiveness of Multiple Dose, Multiple Concentrations of Qwo, for the Treatment of Mild to Moderate Cellulite.
Cellulite
Bottom Line
View on ClinicalTrials.gov: NCT05026216 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Proportion of Subjects With ≥1-point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Buttocks) — 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Qwo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- DMR Research, PLLC
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With ≥1-point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Buttocks) |
3; 2 | — |
| PRIMARY Number of Participants With ≥1-Point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Thighs) |
4; 1 | — |
| SECONDARY I-GAIS at Multiple Timepoints Buttocks |
0; 5; 1; 4; 3; 2 | — |
| SECONDARY I-GAIS at Multiple Timepoints Thighs |
3; 2; 2; 3; 4; 1 | — |
| SECONDARY Mean Change From Baseline in Body-Q Appraisal of Cellulite at Day 90 |
11.6 | — |
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). 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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT05026216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.