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

NCT05026216 | Completed Phase 4 FDA Drug

• 1 other identifier: DMRR-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cellulite

Outcome Measures

Primary Outcomes (1)

• Improved score iGAIS

  The proportion of subjects with changed (+1 or better) score on the Investigator Global Aesthetic Improvement Scale. (I-GAIS) for buttock and thigh from Day 1(baseline) to Day 90(final visit).

  Day 1/Baseline and Day 90

Secondary Outcomes (2)

• BODY-Q- APPRAISAL OF CELLULITE Copyright©2019 Memorial Sloan-Kettering Cancer Center, New York, USA. All rights reserved.

  Day1/Baseline to day 90/final visit

• Dilution Matrix

  Dilution matrix to be used at treatment visits - Day 1, Day 22 and Day 43.

Study Arms (1)

Single-arm study

EXPERIMENTAL

Using CCH-ases on bilateral buttocks and thigh injections. No placebo being used.

Drug: Qwo

Interventions

Qwo DRUG

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.

Single-arm study

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DMR Research, PLLC: lead
• Endo Pharmaceuticals: collaborator

Study Sites (1)

DMR Research, PLLC

Westport, Connecticut, 06880, United States

Location

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: August 30, 2021
• Study Start: March 29, 2021
• Primary Completion: August 15, 2021
• Study Completion: August 31, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

US (1)