A Study to Evaluate the Efficacy, Safety and Tolerability of CT327 in Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT01808157|
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : November 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: CT327 ointment Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||188 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Experimental: 0.05% w/w CT327 ointment
Drug: CT327 ointment
Experimental: 0.5% w/w CT327 ointment
Drug: CT327 ointment
Placebo Comparator: vehicle
- • To determine whether CT327 is effective in reducing pruritus in subjects with atopic dermatitis, using a pruritus visual analogue scale (VAS) [ Time Frame: 4 weeks ]
- • To assess efficacy of CT327 on atopic dermatitis using the Investigator Global Assessment (IGA) [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808157
|Manchester, Lancashire, Midlands, Wales, Scotland, United Kingdom|