NCT04094025

Irritation and Sensitization Study of d-Amphetamine Transdermal System

A Randomized, Evaluator-blinded Study to Evaluate Skin Irritation and Sensitization of d-Amphetamine Transdermal System in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Noven Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study will assess skin irritation as well as sensitization for d-ATS patch in healthy subjects.

Detailed description

This is a randomized, evaluator-blinded study consisting of one (1) group. The study will assess skin irritation as well as sensitization for d-ATS patch in healthy subjects. All three (3) articles (d-ATS patch, placebo patch, and saline patch) will be applied simultaneously on the back of each subject. Healthy subjects will be enrolled to participate in two (2) phases: A Screening Phase and a Treatment Phase. The total duration of the study for each subject will be about 10 - 16 weeks. The Re-challenge Test will only be performed for subjects who experience any type of sensitization during Challenge Period.

Conditions

• Cumulative Irritation and Sensitization

Interventions

Type	Name	Description
DRUG	dATS	d-Amphetamine Transdermal System

Timeline

• Start date: 2019-12-02
• Primary completion: 2020-05-16
• Completion: 2020-05-16
• First posted: 2019-09-18
• Last updated: 2020-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study