CompletedPhase 4

To Assess the Effectiveness of Multiple Dose, Multiple Concentrations of Qwo, for the Treatment of Mild to Moderate Cellulite.

United States5 participantsStarted 2021-03-29

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 agre…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Subjects With ≥1-point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Buttocks)

Timeframe: Day 90

Number of Participants With ≥1-Point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Thighs)

Timeframe: Day 90

Trial details

NCT IDNCT05026216

SponsorDMR Research, PLLC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-15

Results submitted2026-04-09

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