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CBL-514 Injections for Cellulite

Phase 2
Waitlist Available
Research Sponsored by Caliway Biopharmaceuticals Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant scores at least 4 and no greater than 8 on the modified Hexsel CSS at Screening and Day 1
BMI > 18.5 and < 35 kg/m2 and body weight ≥ 50 kg at Screening and Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks from the final treatment visit
Awards & highlights

Study Summary

This trial is studying a new treatment to help people with cellulite. It evaluates safety and effectiveness.

Who is the study for?
This trial is for women aged 18-64 with a certain level of cellulite, known as EFP (Stage 2), who have stable lifestyles and body weight requirements. They must not be on certain medications or have conditions that could affect the study's safety or results, like liver issues, cardiovascular diseases, or recent aesthetic procedures. Participants cannot be pregnant and must use contraception.Check my eligibility
What is being tested?
The trial is testing CBL-514 injections to see if they are effective and safe in treating Stage 2 cellulite. It's an open-label study where all participants receive the treatment without being compared to a placebo or other treatments.See study design
What are the potential side effects?
While specific side effects of CBL-514 aren't listed here, common injection-related side effects may include pain at the injection site, swelling, bruising, redness, itching and potential allergic reactions to ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a specific score on a test called the modified Hexsel CSS that shows the severity of your condition.
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You must have a body mass index (BMI) between 18.5 and 35, and weigh at least 50 kilograms at screening and on the first day of the study.
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Both sides of the back of the thighs will be checked using a specific assessment method called modified Hexsel CSS.
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Women between 18 and 64 years old can participate in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks from the final treatment visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks from the final treatment visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of the score change of edematous fibrosclerotic panniculopathy (EFP) measured by cellulite severity scale from baseline following administration of at least 1 course of CBL-514.
Secondary outcome measures
Evaluation of the response rate of EFP score change by Global Aesthetic Improvement Scale (GAIS) reported by the clinician and participant, respectively, following the administration of at least 1 course of CBL-514.
Evaluation of the total score change of edematous fibrosclerotic panniculopathy (EFP) measured by cellulite severity scale from baseline following administration of at least 1 course of CBL-514.
Percentage of participants' thighs that achieve at least 1-level severity improvement measured by cellulite severity scale from baseline following administration of 1 course of CBL-514.
+1 more
Other outcome measures
Incidence of adverse events and treatment-emergent adverse events (TEAEs)
Incidence of adverse events and treatment-emergent adverse events (TEAEs) at the injection site(s)
Incidence of adverse events and treatment-emergent adverse events (TEAEs) related to the investigational product (IP)
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CBL-514 up to 320mgExperimental Treatment1 Intervention
Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.

Find a Location

Who is running the clinical trial?

Caliway Biopharmaceuticals Co., Ltd.Lead Sponsor
10 Previous Clinical Trials
514 Total Patients Enrolled
1 Trials studying Cellulite
12 Patients Enrolled for Cellulite
Anne SheuStudy DirectorCaliway Biopharmaceuticals Co., Ltd.
6 Previous Clinical Trials
376 Total Patients Enrolled
1 Trials studying Cellulite
12 Patients Enrolled for Cellulite

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical investigation open to those aged 40 or older?

"The upper age limit for candidates in this trial is 64 years old and they must also be of legal adult age."

Answered by AI

Is this research effort currently seeking participants?

"The information on clinicaltrials.gov suggests that this research project is still enrolling volunteers, with the trial having been posted on May 1st 2023 and last edited April 19th of the same year."

Answered by AI

What is the quota for enrolment in this research project?

"This trial requires the participation of 20 qualified participants, who can take part at either Investigational Site 1 in Encino, Florida or Investigational Site 3 in San Diego, New york."

Answered by AI

Am I qualified to join in this clinical research project?

"To be eligible for this clinical study, volunteers need to have cellulite and fall within the 18-64 years old age range. The trial is intending to acquire a total of 20 participants."

Answered by AI

Is the FDA sanctioning CBL-514 dosage up to 320mg?

"Our Power team gave CBL-514 up to 320mg a score of 2, as it has been tested for safety in Phase 2 clinical trials but not yet established efficacy."

Answered by AI

How many healthcare facilities are conducting this research?

"There are 5 recruiting sites for this trial, including Investigational Site 1 in Encino, Investigational Site 3 in San Diego, and Investigational Site 4 in Coral Gables. Additionally, 2 other centres have been identified as potential venues for recruitment."

Answered by AI

Who else is applying?

What state do they live in?
New York
Florida
Other
California
What site did they apply to?
Investigational Site 3
Investigational Site 4
Other
Investigational Site 2
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

I HATE MY CELLULITE. I need help with my condition. I have cellulite and would like to get it resolved.
PatientReceived 2+ prior treatments
Help with my confidence due 2 aging and improving my health. I've tried treatments in the past but haven't found anything that works to tighten my thighs.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long do screening visits take? How long is each visit and how many on-site visits are required?
PatientReceived 1 prior treatment
~12 spots leftby Apr 2025