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 in the Modified Hexsel Cellulite Severity Scale to 4 weeks after the final treatment. The Modified Hexsel Cellulite Severity Scale is based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations.
Time frame: From baseline to 4 weeks after 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 at Least 1 Course of CBL-514.
Change in total scores from baseline in the Modified Hexsel Cellulite Severity Scale to 4 weeks after the final treatment. The Modified Hexsel Cellulite Severity Scale is based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations. 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: From baseline to 4 weeks after 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 from baseline in the Modified Hexsel Cellulite Severity Scale to 12 weeks aftre the final treatment. The Modified Hexsel Cellulite Severity Scale is based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations.
Time frame: From baseline to 12 weeks after 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 at Least 1 Course of CBL-514.
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Investigational Site 2
New York, New York, United States
Change in total scores from baseline in the Modified Hexsel Cellulite Severity Scale to 4 weeks after the final treatment. The Modified Hexsel Cellulite Severity Scale is based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations.
Time frame: From baseline to 4 weeks after the final treatment visit
Percentage of Participants' Thighs With Improvement in Global Aesthetic Improvement Scale (GAIS) Reported by the Clinician, Following the Administration of at Least 1 Course of CBL-514.
The Global Aesthetic Improvement Scale (GAIS) is a 5-point scale to assess aesthetic improvement in appearance compared to pre-treatment, as judged by the Investigator. The rating categories are 'worse', 'no change', 'improved', 'much improved', and 'very much improved'. Improvement in GAIS is defined as "improved", "much improved", and "very much improved".
Time frame: 4 weeks after the final treatment visit
Percentage of Participants' Thighs With Improvement in Global Aesthetic Improvement Scale (GAIS) Reported by the Participant, Following the Administration of at Least 1 Course of CBL-514.
The Global Aesthetic Improvement Scale (GAIS) is a 5-point scale to assess aesthetic improvement in appearance compared to pre-treatment, as judged by the participant. The rating categories are 'worse', 'no change', 'improved', 'much improved', and 'very much improved'. Improvement in GAIS is defined as "improved", "much improved", and "very much improved".
Time frame: 4 weeks after the final treatment visit