NCT01808157

A Study to Evaluate the Efficacy, Safety and Tolerability of CT327 in Atopic Dermatitis

A Phase II Randomised, Double Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of CT327 Topical Ointment (0.05% and 0.5% w/w) Compared to Vehicle, in Subjects With Mild or Moderate Atopic Dermatitis and at Least Moderate Pruritus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Creabilis SA · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, multi-centre, randomised, double-blind, placebo-controlled study in male and female subjects, aged ≥ 12 years with mild/moderate atopic dermatitis and at least moderate pruritus. All subjects will receive BID topical applications of CT327 ointment or vehicle for up to 4 weeks. At baseline, the subjects must have atopic dermatitis, as defined by the Hanifin and Rajka criteria, which involves a minimum of 5% and a maximum of 20% body surface area, an Investigator Global Assessment Score of 2 or 3 (mild or moderate) and pruritus visual analogue scale scores of ≥ 40mm (at least moderate). All subjects will attend a screening visit not more than 21 days prior to Day 1. Subjects will be required to return to the clinic on Days 1 (baseline visit), 4, 11, 18 and 29 (end of treatment visit). All subjects will be asked to attend for a follow-up visit 14 (±3) days after the last dose of study medication.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	CT327 ointment
DRUG	placebo

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-03-11
• Last updated: 2015-11-25

Locations

1 site across 1 country: United Kingdom