A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 2)

Part of paid clinical trials in Encinitas, California.

Sponsor
Caliway Biopharmaceuticals Co., Ltd.
Study ID
NCT05836779
Phase
PHASE2
Status
Completed

Conditions

  • Cellulite

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • CBL-514 injection — DRUG
    CBL-514 will be administered at the raised area of cellulite.

Study Details

The Stage 2 of this phase 2 study is an open-label, single-arm study to assess the efficacy and safety of CBL-514 in participants with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite.

Key Dates

Start date
May 10, 2023
Status verified
May 2024
Primary completion
Nov 29, 2023
Completion
Jan 5, 2024

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CBL-514 up to 320mg
    Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.

Primary Outcome Measure

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. [ Time Frame: 4 weeks from the final treatment visit ]

Locations (5)

FacilityCityStateZIPSite coordinators
Investigational Site 6EncinitasCalifornia92024-
Investigational Site 1EncinoCalifornia91436-
Investigational Site 3San DiegoCalifornia92121-
Investigational Site 4Coral GablesFlorida33146-
Investigational Site 2New YorkNew York10022-

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