NCT02075632

Study to Evaluate Product Duration of Use Experience With Alclometasone Dipropionate Cream

A Mult-Center, Open-Label Study to Evaluate Product Duration of Use Experience With Aclometasone Diproprionate Cream

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label study to evaluate whether participants follow the duration of use instructions for short-term use of alclometasone dipropionate in a population of participants with itchy skin conditions who would use OTC treatments for relief. The study population will be composed of two different cohorts: chronic condition sufferers (eczema or psoriasis) and participants who suffer from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.

Detailed description

Approximately 313 participants who are currently suffering from an itchy skin condition caused by eczema or psoriasis or any occasional itchy skin experiences will be enrolled into the study to get 250 participants who complete the study (at least 100 to each of the cohorts). After evaluation of the study criteria, the site staff will dispense product and a diary card to the subject to use over the next 14 days. At the end of the 14 days, each participant will come to the research site to return the remaining product and undergo the study termination interview with the Concentrics nurse via telephone. The study will be conducted in approximately 15 research sites located throughout the United States (US).

Conditions

• Eczema
• Allergy Symptoms
• Psoriasis
• Itch

Interventions

Type	Name	Description
DRUG	Alclometasone dipropionate cream	Alclometasone dipropionate cream 0.05% (15 g)

Timeline

• Start date: 2006-09-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2014-03-03
• Last updated: 2014-09-05
• Results posted: 2014-07-14