A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma
Lipomas are common mesenchymal, benign, fatty tumors of varying sizes that occur in the
general adult population. They usually present as painful or annoying lumps that are
palpable and often visible in the subcutaneous tissue. Many subcutaneous lipomas are
asymptomatic and are removed for non-medical reasons. However, they may cause the subject
pain or discomfort or interfere with normal activity.
Spontaneous remission of lipomas has not been reported. A lipoma, once it presents itself,
remains there for the lifetime of a person who carries it and may stay small or become
larger. Alternative treatments of the lipoma are surgery or liposuction. If a large
excision is performed there is the problem of having a very large scar and the accompanying
issues of healing a large scar, or possible formation of a hematoma followed by
consolidation of the hematoma and the remnants of a mass of scar tissue. This is often
painful and more problematic than the original lipoma. liposuction also has the potential
for hematoma formation followed by scar mass residual.
To avoid the complications listed above, a non-invasive method of treatment, such as enzyme
mediated disassociation of adipose tissue, would be desirable. The primary aim of this
study is to perform a step-wise approach in dosing to evaluate the safety and efficacy of
clostridium histolyticum as a non-operative treatment for lipoma.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Reduction in visible surface area of the lipoma
The primary efficacy outcome is the visible surface area of the lipoma measured as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be determined by caliper and will be analyzed as the percent change from baseline at the 6-month post injection visit.
Six months post injection of study drug
Zachary E Gerut, M.D.
Gerut, Zachary, M.D.
United States: Food and Drug Administration
|Zachary E. Gerut, M.D.||Hewlett, New York 11557|