Trial Outcomes & Findings for Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas (NCT NCT00624416)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Baseline and 4 weeks

Results posted on

2015-12-21

Participant milestones
Measure	Prednisolone and Isoproteronol Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas

Baseline characteristics by cohort
Measure	Prednisolone and Isoproteronol n=10 Participants Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

Timeframe: Baseline and 4 weeks

Outcome measures
Measure	Prednisolone and Isoproteronol n=10 Lipoma Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
The Average Percent Volume Reduction in the Lipoma.	50 Percent Volume reduction (cc^3) Full Range 0.002 • Interval 10.0 to 90.0

Timeframe: After four weeks of treatment up to one year.

Outcome measures
Measure	Prednisolone and Isoproteronol n=10 Lipoma Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
The Number of Lipoma Increased in Volume.	9 Lipomas

Timeframe: After four weeks up to one year.

Outcome measures
Measure	Prednisolone and Isoproteronol n=10 Lipoma Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
The Number of Subjects Elected to Have the Lipoma Removed.	8 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Pennington Biomedical Research Center

Phone: 225-763-0947