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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01808157
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):
Creabilis SA

Brief 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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: CT327 ointment Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching

Arm Intervention/treatment
Experimental: 0.05% w/w CT327 ointment
Active
Drug: CT327 ointment
Experimental: 0.5% w/w CT327 ointment
Active
Drug: CT327 ointment
Placebo Comparator: vehicle
Placebo
Drug: placebo



Primary Outcome Measures :
  1. • 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 ]

Secondary Outcome Measures :
  1. • To assess efficacy of CT327 on atopic dermatitis using the Investigator Global Assessment (IGA) [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male and female subjects aged ≥ 12 years.

Clinical diagnosis of atopic dermatitis (as defined by Hanifin and Rajka criteria (Appendix F) at screening with:

  • IGA score of 2 or 3 (mild or moderate)
  • Score of ≥ 40mm on all screening pruritus VAS assessments (average and worst over the last 24 hours and current itch)
  • A minimum of 5% and not more than 20% of the subjects' BSA affected by atopic dermatitis (affected is defined as active atopic dermatitis lesions or pruritus)
  • Amenable to treatment with topical treatment
  • Stable disease for ≥1 months prior to screening

Exclusion Criteria:

Atopic dermatitis only affecting the head or scalp. Unstable or actively infected atopic dermatitis. Concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug.

Subjects who have received monoclonal antibody therapy for their atopic dermatitis in the 4 months prior to screening.

Subjects who have used systemic immunosuppressive drugs, corticosteroids or received PUVA therapy in the 4 weeks prior to starting study treatment, or are scheduled to start these treatments during the study period.

Subjects who have used topical immunomodulators (pimecrolimus, tacrolimus) within 2 weeks of starting study treatment or are scheduled to start these treatments during the study period.

Subjects who have used topical corticosteroids from WHO group II, III or IV, or other treatments for atopic dermatitis, including wet wraps, within 2 weeks prior to starting study treatment or are likely to require treatment with these medications during the study period.

Subjects who are unable to abstain from using emollients from baseline (Visit 2) until the end of study treatment (Visit 6).

Subjects who are using any concomitant medication(s) that, in the investigators' opinion, could affect the subject's atopic dermatitis or pruritus (for example TADs, SSRI, pregabalin). Subjects using such medications may be included, at the investigators discretion, if they have been stable on treatment for at least 1 month prior to the start of study treatment and no changes to these medications are planned during the study period.

Subjects undergoing, or due to have, UVA, or UVB therapy in the 2 weeks prior to starting study treatment or during the study period.

Planned exposure of affected areas to excessive sunlight. Subjects with a clinically significant abnormal laboratory safety test and/or 12-lead ECG results at screening.

Subjects who are receiving any investigational drug or who have taken part in a clinical study with an investigational drug within three months prior to the start of study treatment.

Subjects with a known reaction or allergy to test drug or excipients.


Information from the National Library of Medicine

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


Locations
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United Kingdom
Synexus
Manchester, Lancashire, Midlands, Wales, Scotland, United Kingdom
Sponsors and Collaborators
Creabilis SA

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Responsible Party: Creabilis SA
ClinicalTrials.gov Identifier: NCT01808157     History of Changes
Other Study ID Numbers: CT327-2005
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015

Keywords provided by Creabilis SA:
atopic dermatitis
pruritus

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases