Trial results for CBL-514 in participants with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite were posted on 2026-07-09. The PHASE2 study (NCT05836779) reported a mean change of -1.2 scores on the Cellulite Severity Scale from baseline, with 18 thighs achieving at least a 1-level severity improvement.

Background

CBL-514 is under investigation for the treatment of Edematous Fibrosclerotic Panniculopathy (EFP) cellulite, specifically targeting Stage 2 cellulite. This condition is characterized by changes in the skin's appearance, often requiring aesthetic interventions.

Trial design

The study, identified as NCT05836779, was conducted as an open-label, single-arm PHASE2 trial. It enrolled 23 participants diagnosed with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite. The intervention involved CBL-514 injection, administered at doses up to 320mg. The study's primary focus was to assess the efficacy and safety of CBL-514 in this patient population.

Key results

Efficacy outcomes demonstrated a mean score change of -1.2 scores (Standard Deviation 1.3) on the Cellulite Severity Scale from baseline following administration of at least one course of CBL-514. A separate evaluation of the total score change also showed a mean of -1.2 scores (Standard Deviation 1.2) on the same scale. Regarding improvement levels, 18 thighs achieved at least a 1-level severity improvement, and 14 thighs achieved at least a 2-score improvement as measured by the Cellulite Severity Scale from baseline. Clinician-reported Global Aesthetic Improvement Scale (GAIS) showed improvement in 41 thighs, while participant-reported GAIS indicated improvement in 39 thighs.

Safety data showed that 14 participants experienced treatment-emergent adverse events (TEAEs), with another measure reporting 13 participants with TEAEs. The total number of TEAEs reported was 210 events, with another measure reporting 105 events. 3 participants experienced adverse events of special interest. Notably, 0 participants had clinically significant abnormalities in laboratory tests.

Statistical analysis using a paired t-test for the modified Hexsel CSS total score at 4 weeks from the final treatment visit compared with baseline yielded a p-value of 1e-05. Another paired t-test also showed a p-value of 1e-05.

What this means

The results from this PHASE2 study suggest that CBL-514 may offer a beneficial effect in reducing the severity of Edematous Fibrosclerotic Panniculopathy (EFP) cellulite. The consistent mean reduction in Cellulite Severity Scale scores, alongside the reported improvements in severity levels and positive assessments from both clinicians and participants on the Global Aesthetic Improvement Scale, indicate potential aesthetic and clinical benefits. The safety profile, with 0 participants experiencing clinically significant laboratory abnormalities, provides initial reassurance regarding the drug's tolerability, although TEAEs were observed. These findings support further investigation into CBL-514 as a treatment option for cellulite.

Source

These trial results were posted on ClinicalTrials.gov on 2026-07-09. The full details of the study, NCT05836779, are available on clinicaltrials.gov.