Conditions: Ankle Sprain
Keywords: Ankle Sprain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 252
Healthy volunteers: no

Brief summary:
The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).

Detailed description:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain

Arms:
arm 1: One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) arm 2: One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)

Interventions: intervention 1: FS-67 Patch intervention 2: Placebo Patch
Intervention descriptions: intervention 1: One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) intervention 2: One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)

Protocol document: