Atopic DermatitisPhase 1NCT02103725
A Multi-Centre Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis
A Phase 1 study testing pimecrolimus 10 mg/g cream in people with Atopic Dermatitis, run by LEO Pharma at 1 site in Germany.
Trial summary
The purpose of this study is to validate a left-right design with respect to detecting a difference in efficacy after 3 weeks of treatment between an active treatment and a vehicle in adults with mild to moderate atopic dermatitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- pimecrolimus 10 mg/g cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Sep 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male and female subjects, 18 years or older
- 2. Subject with atopic dermatitis with mild to moderate disease severity
- 3. Two symmetrical and comparable atopic dermatitis treatment areas
- 4. Female volunteers of childbearing potential must either be surgically sterile or agree to use a reliable method of contraception
Who cannot join
- 1. Any condition in the target 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
- 2. Dark-skinned persons whose skin colour prevents reliable clinical assessments
- 3. Any permanent (or transient within 28 days prior to dosing) disease that may interfere with the subjects safe participation in the trial, with the subjects ability to participate in the trial or with the clinical assessments
- 4. Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Multi-Centre, Randomised, Vehicle-Controlled, Double-Blinded, Explorative Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis Over a Treatment Period of Three Weeks
The purpose of this study is to validate a left-right design with respect to detecting a difference in efficacy after 3 weeks of treatment between an active treatment and a vehicle in adults with mild to moderate atopic dermatitis
- Conditions
- Atopic Dermatitis
- Being tested
- pimecrolimus 10 mg/g cream, Vehicle cream
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pimecrolimus 10 mg/g creamDrug
Vehicle creamDrug
| Study group | Role | What they receive |
|---|---|---|
| pimecrolimus 10 mg/g cream | Experimental | Active drug Receives: Drug: pimecrolimus 10 mg/g cream |
| Vehicle cream | Placebo comparator | Placebo drug Receives: Drug: Vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the treatment effect defined as total sign score on the treated area at end of the 3 weeks treatment period
Measured: 3 weeks
Secondary outcomes (1)
Incidence of adverse events during the 3 weeks treatment period
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 posted4 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT02103725
- Sponsor's protocol ID
- EXP-1092
- Status last verified
- Dec 2013
- First submitted
- 26 Mar 2014
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-Centre, Randomised, Vehicle-Controlled, Double-Blinded, Explorative Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis Over a Treatment Period of Three Weeks
- ClinicalTrials.gov ID
- NCT02103725
- Acronym / sponsor ID
- EXP-1092
- 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
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Apr 2014 (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 purpose of this study is to validate a left-right design with respect to detecting a difference in efficacy after 3 weeks of treatment between an active treatment and a vehicle in adults with mild to moderate atopic dermatitis
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pimecrolimus 10 mg/g cream | Experimental | Drug: pimecrolimus 10 mg/g creamActive drug |
| Vehicle cream | Placebo comparator | Drug: Vehicle creamPlacebo drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Male and female subjects, 18 years or older
- 2. Subject with atopic dermatitis with mild to moderate disease severity
- 3. Two symmetrical and comparable atopic dermatitis treatment areas
- 4. Female volunteers of childbearing potential must either be surgically sterile or agree to use a reliable method of contraception
Key exclusion criteria (4 listed)
- 1. Any condition in the target 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
- 2. Dark-skinned persons whose skin colour prevents reliable clinical assessments
- 3. Any permanent (or transient within 28 days prior to dosing) disease that may interfere with the subjects safe participation in the trial, with the subjects ability to participate in the trial or with the clinical assessments
- 4. Pregnancy or breastfeeding
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 |
|---|---|---|
| pimecrolimus 10 mg/g cream | Drug | pimecrolimus 10 mg/g cream |
| Vehicle cream | Drug | Vehicle cream |
Primary outcome
Evaluation of the treatment effect defined as total sign score on the treated area at end of the 3 weeks treatment period
Time frame: 3 weeks
1 secondary outcome
Incidence of adverse events during the 3 weeks treatment period
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 24 Feb 2025.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 pimecrolimus 10 mg/g 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 4 inclusion and 4 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 24 Feb 2025. 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?
Evaluation of the treatment effect defined as total sign score on the treated area at end of the 3 weeks treatment period (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 24 Feb 2025.