Atopic DermatitisPhase 2NCT01037881
LEO 29102 Cream in the Treatment of Atopic Dermatitis
A Phase 2 study testing LEO 29102 and Elidel® in people with Atopic Dermatitis, run by LEO Pharma at 3 sites in 3 countries.
Trial summary
This is a proof of concept and dose finding Phase II trial comparing 5 dose strengths with vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment regimen in mild to moderate atopic dermatitis patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- LEO 29102 and Elidel®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Dec 2009to Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of atopic dermatitis defined according to Hanifin and Rajka
- IGA assessment scored as mild (2) to moderate (3) atopic dermatitis
- Treatment lesions located on the trunk and limbs
- Treatment lesions involving 3% to 10% of the total body surface area
- Patients of either gender between 18 years and 65 years of age
Who cannot join
- Systemic treatment with immunosuppressive drugs or corticosteroids within 6 weeks prior to randomisation
- Topical treatment with immunomodulators (pimecrolimus, tacrolimus) within 2 weeks prior to randomisation
- Topical treatment with corticosteroids from WHO groups II, III or IV within 1 week prior to randomisation
- Use of topical or systemic antibiotics within 2 weeks prior to randomisation
- PUVA or UVB therapy within 4 weeks prior to randomisation
- Clinical infection (viral, fungal or bacterial) on the treatment area
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- Known or suspected severe renal insufficiency or severe hepatic disorders
- Patients with history of an immunocompromised disease (e.g., lymphoma, HIV, Wiskott-Aldrich Syndrome)
- Patients with concomitant serious disease (e.g., cancer) which might affect the AD treatment in this trial
- Females who are pregnant or are breast feeding
- Females intending to temporarily or permanently stop their hormonal contraceptive regime during and up to one month post study termination visit
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
Klinik und Poliklinik für Dermatologie, Universität Bonn
Bonn, 53105
About this study
Official title: A Phase 2, Proof of Concept and Dose Finding Study, Investigating Treatment Efficacy of LEO 29102 Cream, LEO 29102 Cream Vehicle, and Elidel® Cream 10 mg/g, After Cutaneous Administration Twice Daily for 4 Weeks
This is a proof of concept and dose finding Phase II trial comparing 5 dose strengths with vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment regimen in mild to moderate atopic dermatitis patients.
- Conditions
- Atopic Dermatitis
- Being tested
- LEO 29102, Elidel®
- 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 29102Drug
comparison of different dosages of drug
Elidel®Drug
comparison
| Study group | Role | What they receive |
|---|---|---|
| LEO 29102 0.03 mg/g cream | Experimental | Not described Receives: Drug: LEO 29102 |
| LEO 29102 0.1 mg/g cream | Experimental | Not described Receives: Drug: LEO 29102 |
| LEO 29102 0.3 mg/g cream | Experimental | Not described Receives: Drug: LEO 29102 |
| LEO 29102 1.0 mg/g cream | Experimental | Not described Receives: Drug: LEO 29102 |
| LEO 29102 2.5 mg/g cream | Experimental | Not described Receives: Drug: LEO 29102 |
| LEO 29102 cream vehicle | Placebo comparator | Not described Receives: Drug: LEO 29102 |
| Elidel® cream (pimecrolimus) 10 mg/g | Active comparator | Not described Receives: Drug: Elidel® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF])
The EASI is a composite score based on the evaluation of four characteristic atopic dermatitis (AD) signs and symptoms; erythema, oedema/induration/papulation, excoriation and lichenification together with the area involved.
For each body region, the investigator rated four clinical signs of AD using the following severity scale:
0 = none/absent
- = mild
- = moderate
- = severe
The EASI score ranges from 0-12, a higher score equals a worse outcome. Baseline was defined as Day 0. Mean values in table are least squares mean adjusted for the effect of (pooled) country.
Measured: Baseline (Day 0) and end of treatment (Day 28)
Secondary outcomes (5)
Number of Participants That Were Symptom Free Responders (LOCF)
The IGA (Investigator's global assessment) of disease severity on the body (trunk and limbs excluding the hands) was assessed based on visual evaluation by use of the following definitions of severity:
- Clear - no inflammatory signs of AD
- Almost clear - just perceptible erythema, and just perceptible papulation/infiltration
- Mild - mild erythema, and mild papulation/infiltration
- Moderate - moderate erythema, and moderate papulation/infiltration
- Severe - severe erythema, and-severe papulation/infiltration
- Very severe - severe erythema, and severe papulation/infiltration with oozing/crusting.
Symptom free responders were defined as an IGA of 0 (Clear) or 1 (Almost clear) at the end of treatment.
Measured: At end of treatment (Day 28)
Participants' Assessment of Pruritus on Trunk and Limbs
Participants' assessment of pruritus on trunk and limbs was assessed at end of treatment by use of the scale below.
- Absent - no itching
- Mild - occasional, slight itching
- Moderate - constant or intermittent itching which is not disturbing sleep
- Severe - intolerable itching which is disturbing sleep
The assessment was based on the average degree of pruritus over the last 24 hours.
Measured: At end of treatment (Day 28)
Participants' Overall Assessment of Disease Severity
Participants' overall assessment of disease severity on trunk and limbs (excluding the hands) was assessed at end of treatment by use of the following scale: clear, very mild, mild, moderate, severe.
The assessment was based on the condition of the disease at the time of the evaluation and not in relation to the condition at a previous visit.
Measured: At end of treatment (Day 28)
Number of Participants That Were Symptom Free Responders by Visit
Symptom free responders were defined as an IGA of 0 (Clear) or 1 (Almost clear) according to Investigator's global assessment of disease severity on trunk and limbs at the end of treatment.
Measured: At Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21) and end of treatment (Day 28)
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit
The EASI is a composite score based on the evaluation of four characteristic atopic dermatitis (AD) signs and symptoms; erythema, oedema/induration/papulation, excoriation and lichenification together with the area involved.
For each body region, the investigator rated four clinical signs of AD using the following severity scale:
0 = none/absent
- = mild
- = moderate
- = severe The EASI score ranges from 0-12, a higher score equals a worse outcome. Baseline was defined as Day 0. Mean values in table are least squares mean adjusted for the effect of (pooled) country.
Measured: Baseline and at Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037881
- Sponsor's protocol ID
- LEO 29102-C21
- Other IDs
- EudraCT Number 2009-013792-22
- Status last verified
- Aug 2018
- First submitted
- 21 Dec 2009
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Proof of Concept and Dose Finding Study, Investigating Treatment Efficacy of LEO 29102 Cream, LEO 29102 Cream Vehicle, and Elidel® Cream 10 mg/g, After Cutaneous Administration Twice Daily for 4 Weeks
- ClinicalTrials.gov ID
- NCT01037881
- Acronym / sponsor ID
- LEO 29102-C21
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 23 Dec 2009 (estimated)
- Results
- Posted 14 Oct 2019
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 proof of concept and dose finding Phase II trial comparing 5 dose strengths with vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment regimen in mild to moderate atopic dermatitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| LEO 29102 0.03 mg/g cream | Experimental | Drug: LEO 29102 |
| LEO 29102 0.1 mg/g cream | Experimental | Drug: LEO 29102 |
| LEO 29102 0.3 mg/g cream | Experimental | Drug: LEO 29102 |
| LEO 29102 1.0 mg/g cream | Experimental | Drug: LEO 29102 |
| LEO 29102 2.5 mg/g cream | Experimental | Drug: LEO 29102 |
| LEO 29102 cream vehicle | Placebo comparator | Drug: LEO 29102 |
| Elidel® cream (pimecrolimus) 10 mg/g | Active comparator | Drug: Elidel® |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of atopic dermatitis defined according to Hanifin and Rajka
- IGA assessment scored as mild (2) to moderate (3) atopic dermatitis
- Treatment lesions located on the trunk and limbs
- Treatment lesions involving 3% to 10% of the total body surface area
- Patients of either gender between 18 years and 65 years of age
Key exclusion criteria (11 listed)
- Systemic treatment with immunosuppressive drugs or corticosteroids within 6 weeks prior to randomisation
- Topical treatment with immunomodulators (pimecrolimus, tacrolimus) within 2 weeks prior to randomisation
- Topical treatment with corticosteroids from WHO groups II, III or IV within 1 week prior to randomisation
- Use of topical or systemic antibiotics within 2 weeks prior to randomisation
- PUVA or UVB therapy within 4 weeks prior to randomisation
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 29102comparison of different dosages of drug | Drug | LEO 29102 0.03 mg/g cream, LEO 29102 0.1 mg/g cream, LEO 29102 0.3 mg/g cream, LEO 29102 1.0 mg/g cream, LEO 29102 2.5 mg/g cream, LEO 29102 cream vehicle |
| Elidel®comparison | Drug | Elidel® cream (pimecrolimus) 10 mg/g |
Primary outcome
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF])
Time frame: Baseline (Day 0) and end of treatment (Day 28)
The EASI is a composite score based on the evaluation of four characteristic atopic dermatitis (AD) signs and symptoms; erythema, oedema/induration/papulation, excoriation and lichenification together with the area involved. For each body region, the investigator rated four clinical signs of AD using the following severity scale: 0 = none/absent 1. = mild 2. = moderate 3. = severe The EASI score ranges from 0-12, a higher score equals a worse outcome. Baseline was defined as Day 0. Mean values in table are least squares mean adjusted for the effect of (pooled) country.
5 secondary outcomes
Number of Participants That Were Symptom Free Responders (LOCF)
Time frame: At end of treatment (Day 28)
Participants' Assessment of Pruritus on Trunk and Limbs
Time frame: At end of treatment (Day 28)
Participants' Overall Assessment of Disease Severity
Time frame: At end of treatment (Day 28)
Number of Participants That Were Symptom Free Responders by Visit
Time frame: At Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21) and end of treatment (Day 28)
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit
Time frame: Baseline and at Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Medical Expert study director
LEO Pharma
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEO 29102 and Elidel® in people with Atopic Dermatitis, run by LEO Pharma at 3 sites in 3 countries.
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 5 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 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Finland, 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 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?
Yes. Results are posted in the registry (first posted 14 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF]) (time frame: Baseline (Day 0) and end of treatment (Day 28)). 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 10 Mar 2025.