Atopic DermatitisPhase 2NCT01808157
A Study to Evaluate the Efficacy, Safety and Tolerability of CT327 in Atopic Dermatitis
A Phase 2 study testing CT327 ointment in people with Atopic Dermatitis, run by Creabilis SA at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- CT327 ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2013to Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Synexus
Manchester, Lancashire, Midlands, Wales, Scotland
About this study
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
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
- Being tested
- CT327 ointment, placebo
- Keywords
- atopic dermatitis, pruritus
- Medical subject headings
- Dermatitis, Atopic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT327 ointmentDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 0.05% w/w CT327 ointment | Experimental | Active Receives: Drug: CT327 ointment |
| 0.5% w/w CT327 ointment | Experimental | Active Receives: Drug: CT327 ointment |
| vehicle | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
• To determine whether CT327 is effective in reducing pruritus in subjects with atopic dermatitis, using a pruritus visual analogue scale (VAS)
Measured: 4 weeks
Secondary outcomes (1)
• To assess efficacy of CT327 on atopic dermatitis using the Investigator Global Assessment (IGA)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creabilis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808157
- Sponsor's protocol ID
- CT327-2005
- Status last verified
- Nov 2015
- First submitted
- 7 Mar 2013
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01808157
- Acronym / sponsor ID
- CT327-2005
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Creabilis SAIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.05% w/w CT327 ointment | Experimental | Drug: CT327 ointmentActive |
| 0.5% w/w CT327 ointment | Experimental | Drug: CT327 ointmentActive |
| vehicle | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT327 ointment | Drug | 0.05% w/w CT327 ointment, 0.5% w/w CT327 ointment |
| placebo | Drug | vehicle |
Primary outcome
• 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
1 secondary outcome
• To assess efficacy of CT327 on atopic dermatitis using the Investigator Global Assessment (IGA)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT327 ointment in people with Atopic Dermatitis, run by Creabilis SA at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2015.