Atopic DermatitisPhase 1NCT02496546
An Explorative Trial Evaluating the Effect of LEO 32731 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)
A Phase 1 study testing LEO 32731 cream in people with Atopic Dermatitis, run by LEO Pharma at 1 site in Germany.
Trial summary
The aim of this trial is to assess the efficacy of LEO 32731 cream 20 mg/g compared with LEO 32731 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- LEO 32731 cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2015to Mar 2016
- Phase
- Phase 1
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Following verbal and written information about the trial, subjects must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures being carried out
- Subject with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3) as assessed by a dermatologically trained investigator (and confirmed by a board certified dermatologist before or at visit 1)
- Two symmetrically located and comparable Entire Treatment Areas (ETAs) of 20 - 50 cm2 each, i.e. on the same body region (left and right part) and of the same size (complete AD lesion or part of an AD lesion); Total Sign Score (TSS) of at least 5 on both ETAs; difference in TSS not greater than 2 between the two ETAs; sign score for erythema ≥ 2 on both ETAs; difference in Investigator´s Treatment Area assessment of disease severity not greater than 1 between the 2 ETAs
Who cannot join
- Any condition in the treatment areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash (other than Atopic Dermatitis), sunburn, hyper- or hypopigmentation, scars
Trial locations and contacts
1 site in 1 country.
Germany1 site
Proinnovera GmbH, Center of Dermatology Excellence
Münster, 48159
About this study
Official title: An Explorative Trial Evaluating the Effect of LEO 32731 Cream 20 mg/g in Adults With Mild to Moderate Atopic Dermatitis (AD)
The aim of this trial is to assess the efficacy of LEO 32731 cream 20 mg/g compared with LEO 32731 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.
- Conditions
- Atopic Dermatitis
- Being tested
- LEO 32731 cream, LEO 32731 cream vehicle
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 32731 creamDrug
Applied for 3 weeks
LEO 32731 cream vehicleDrug
Applied for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| LEO 32731 cream | Experimental | Topical application Receives: Drug: LEO 32731 cream |
| LEO 32731 cream vehicle | Placebo comparator | Topical application Receives: Drug: LEO 32731 cream vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sign score at end of treatment on entire treatment area
Total sign score is defined as the sum of severity scores (4-point scale) of the Individual Sign Scores (erythema, edema/papulation, oozing/crusting, excoriations, lichenification and dryness) for each area
Measured: 3 weeks
Secondary outcomes (6)
Total sign score on limited treatment area on entire treatment area during trial
Measured: 3 week
Investigator's treatment area assessment of disease severity on entire treatment area during trial
Measured: 3 weeks
Subject's treatment area assessment of disease severity on entire treatment area during trial
Measured: 3 weeks
Subject's assessment of itching on entire treatment area during trial
Measured: 3 weeks
Transepidermal water loss during trial
Measured: 3 weeks
Individual signs score on entire treatment during trial
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionMar 2016
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496546
- Sponsor's protocol ID
- LP0108-1082
- Other IDs
- 2014-000519-15, 2014
- Status last verified
- May 2017
- First submitted
- 9 Jul 2015
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Trial Evaluating the Effect of LEO 32731 Cream 20 mg/g in Adults With Mild to Moderate Atopic Dermatitis (AD)
- ClinicalTrials.gov ID
- NCT02496546
- Acronym / sponsor ID
- LP0108-1082
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Jul 2015 (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.
The aim of this trial is to assess the efficacy of LEO 32731 cream 20 mg/g compared with LEO 32731 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEO 32731 cream | Experimental | Drug: LEO 32731 creamTopical application |
| LEO 32731 cream vehicle | Placebo comparator | Drug: LEO 32731 cream vehicleTopical application |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Following verbal and written information about the trial, subjects must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures being carried out
- Subject with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3) as assessed by a dermatologically trained investigator (and confirmed by a board certified dermatologist before or at visit 1)
- Two symmetrically located and comparable Entire Treatment Areas (ETAs) of 20 - 50 cm2 each, i.e. on the same body region (left and right part) and of the same size (complete AD lesion or part of an AD lesion); Total Sign Score (TSS) of at least 5 on both ETAs; difference in TSS not greater than 2 between the two ETAs; sign score for erythema ≥ 2 on both ETAs; difference in Investigator´s Treatment Area assessment of disease severity not greater than 1 between the 2 ETAs
Key exclusion criteria (1 listed)
- Any condition in the treatment areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash (other than Atopic Dermatitis), sunburn, hyper- or hypopigmentation, scars
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 |
|---|---|---|
| LEO 32731 creamApplied for 3 weeks | Drug | LEO 32731 cream |
| LEO 32731 cream vehicleApplied for 3 weeks | Drug | LEO 32731 cream vehicle |
Primary outcome
Total sign score at end of treatment on entire treatment area
Time frame: 3 weeks
Total sign score is defined as the sum of severity scores (4-point scale) of the Individual Sign Scores (erythema, edema/papulation, oozing/crusting, excoriations, lichenification and dryness) for each area
6 secondary outcomes
Total sign score on limited treatment area on entire treatment area during trial
Time frame: 3 week
Investigator's treatment area assessment of disease severity on entire treatment area during trial
Time frame: 3 weeks
Subject's treatment area assessment of disease severity on entire treatment area during trial
Time frame: 3 weeks
Subject's assessment of itching on entire treatment area during trial
Time frame: 3 weeks
Transepidermal water loss during trial
Time frame: 3 weeks
Individual signs score on entire treatment during trial
Time frame: 3 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 3 May 2017.
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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 1 study testing LEO 32731 cream in people with Atopic Dermatitis, run by LEO Pharma at 1 site in Germany.
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 3 inclusion and 1 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 3 May 2017. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Total sign score at end of treatment on entire treatment area (time frame: 3 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 3 May 2017.