NCT02849860

Absorption and Systematic Pharmacokinetics of IDP-121 Lotion in Subjects With Acne Vulgaris

A Phase 1b Open-Label Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-121 Lotion in Subjects With Acne Vulgaris Under Maximal Use Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 9 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant metabolites after topical dermal application of IDP-121 lotion.

Detailed description

Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant metabolites after topical dermal application of IDP-121 lotion in subjects with moderate to severe acne vulgaris under maximal use conditions.

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	IDP-121 Lotion	Lotion

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2016-07-29
• Last updated: 2017-12-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study