NCT00721331

A Phase I Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers

A Phase I, Single-Center, Randomized, Vehicle-Controlled Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Zalicus · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This will be a phase I, single center, randomized, vehicle-controlled, blinded study comparing two dosage strengths of CRx-197 cream, nortriptyline, an active comparator (0.1% mometasone) and placebo (the active ingredient free vehicle cream of CRx-197)in healthy volunteers.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	nortriptyline HCl + loratadine	Topical
DRUG	nortriptyline HCl + loratadine	Topical
DRUG	nortriptyline HCl	Topical
DRUG	mometasone furoate	Topical
DRUG	Active ingredient free vehicle cream of CRx-197	Topical

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-07-24
• Last updated: 2008-09-26

Locations

1 site across 1 country: Germany