Back to results

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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

CT327 ointment

placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, pruritus

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Synexus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

0.05% w/w CT327 ointment

0.5% w/w CT327 ointment

vehicle

Arm Description

Active

Placebo

Outcomes

Primary Outcome Measures

• To determine whether CT327 is effective in reducing pruritus in subjects with atopic dermatitis, using a pruritus visual analogue scale (VAS)

Secondary Outcome Measures

• To assess efficacy of CT327 on atopic dermatitis using the Investigator Global Assessment (IGA)

Full Information

NCT ID

NCT01808157

First Posted

March 7, 2013

Last Updated

November 24, 2015

Sponsor

Creabilis SA

1. Study Identification

Unique Protocol Identification Number

NCT01808157

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Creabilis SA

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

atopic dermatitis, pruritus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

188 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.05% w/w CT327 ointment

Arm Type

Experimental

Arm Description

Active

Arm Title

0.5% w/w CT327 ointment

Arm Type

Experimental

Arm Description

Active

Arm Title

vehicle

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

CT327 ointment

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

• 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 Measure Information:

Title

• To assess efficacy of CT327 on atopic dermatitis using the Investigator Global Assessment (IGA)

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Synexus

City

Manchester, Lancashire, Midlands, Wales, Scotland

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs