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.
This Phase 2a study has an integrated design consisting of a single ascending dose (SAD) part in Stage 1 followed by a single-arm design in Stage 2. The Stage 2 will include a total of 20 participants enrolled in 1 selected CBL-514 dose. Eligible participants will be sequentially assigned to receive up to 2 courses of allocated CBL-514 dose administered by subcutaneous injection on both sides of the posterolateral thighs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
CBL-514 will be administered at the raised area of cellulite.
Investigational Site 6
Encinitas, California, United States
Investigational Site 1
Encino, California, United States
Investigational Site 3
San Diego, California, United States
Investigational Site 4
Coral Gables, Florida, United States
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.
Change in total scores from baseline according to the modified Hexsel CSS at V4 based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations following administration of at least 1 course of CBL-514. (A) Number of evident depressions: '0' = None/no depressions '1' = 1 to 4 depressions are visible '2' = 5 to 9 depressions are visible '3' = 10 or more depressions are visible (B) Depth of depressions: '0' = No depressions '1' = Superficial depressions '2' = Medium depth depressions '3' = Deep depressions (C) Morphological appearance of skin surface alterations: '0' = No raised areas '1' = 'Orange peel' appearance '2' = 'Cottage cheese' appearance '3' = 'Mattress' appearance The total score of (A), (B) and (C) will determine the cellulite severity level as follows : 0 = None 1-3 = Mild 4-6 = Moderate 7-9 = Severe
Time frame: 4 weeks from the final treatment visit
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.
Percentage of participants' thighs with at least 1-level severity improvement determined by the total scores of modified Hexsel CSS at V4 and V5 compared to baseline.
Time frame: Up to 12 weeks from the final treatment visit
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.
Change in total scores according to the modified Hexsel CSS at V5.
Time frame: 12 weeks from the final treatment visit
Percentage of participants' thighs that achieve at least 2-score improvement measured by cellulite severity scale from baseline following administration of 1 course of CBL-514.
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Investigational Site 2
New York, New York, United States
Percentage of participants' thighs with achieve at least 2-score improvement in modified Hexsel CSS at V4 and V5.
Time frame: Up to 12 weeks from the final treatment visit
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.
Percentage of participants with a score change in GAIS assessed by the clinician and participant, respectively.
Time frame: Up to 12 weeks from the final treatment visit