Atopic DermatitisPhase 1NCT01005823
A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis
A Phase 1 study testing LEO 29102 cream in people with Atopic Dermatitis, run by LEO Pharma at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of 7 days treatment with LEO 29102 in adult patients with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- LEO 29102 cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2009to May 2010
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-55 years
- Atopic dermatitis of 850-1700cm2
- In good health
- Criteria for exclusion:
- Co-morbid conditions
- Hepatic dysfunction
Show all 11Show fewer
- Clinical infection
- Immunocompromised status
- Clinically significant illness
- Use of immunomodulating treatment
- Medications related to respiratory system or to heart rhythm
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of 7 days treatment with LEO 29102 in adult patients with atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- LEO 29102 cream, LEO 29102 placebo 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.
LEO 29102 creamDrug
Twice daily application for 7 days
LEO 29102 placebo creamDrug
LEO 29102 placebo cream
| Study group | Role | What they receive |
|---|---|---|
| LEO 29102 cream 0.3 mg/g | Active comparator | Not described Receives: Drug: LEO 29102 cream |
| LEO 29102 cream 1.0 mg/g | Active comparator | Not described Receives: Drug: LEO 29102 cream |
| LEO 29102 cream 2.5 mg/g | Active comparator | Not described Receives: Drug: LEO 29102 cream |
| LEO 29102 placebo cream | Placebo comparator | Not described Receives: Drug: LEO 29102 placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, laboratory testing, ECG, vital signs
Measured: Day 9
Secondary outcomes (1)
To assess the efficacy of LEO 29102 cream in the treatment of AD
Measured: Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionMay 2010
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kahlid Aboufarha, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005823
- Sponsor's protocol ID
- LEO 29102-C03
- Other IDs
- EudraCT No. 2009-014303-30
- Status last verified
- Dec 2010
- First submitted
- 23 Oct 2009
- 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 Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01005823
- Acronym / sponsor ID
- LEO 29102-C03
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Nov 2009 (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 evaluate the safety, tolerability and pharmacokinetics of 7 days treatment with LEO 29102 in adult patients with atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LEO 29102 cream 0.3 mg/g | Active comparator | Drug: LEO 29102 cream |
| LEO 29102 cream 1.0 mg/g | Active comparator | Drug: LEO 29102 cream |
| LEO 29102 cream 2.5 mg/g | Active comparator | Drug: LEO 29102 cream |
| LEO 29102 placebo cream | Placebo comparator | Drug: LEO 29102 placebo cream |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age 18-55 years
- Atopic dermatitis of 850-1700cm2
- In good health
- Co-morbid conditions
- Hepatic dysfunction
Key exclusion criteria (0 listed)
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 29102 creamTwice daily application for 7 days | Drug | LEO 29102 cream 0.3 mg/g, LEO 29102 cream 1.0 mg/g, LEO 29102 cream 2.5 mg/g |
| LEO 29102 placebo creamLEO 29102 placebo cream | Drug | LEO 29102 placebo cream |
Primary outcome
Adverse events, laboratory testing, ECG, vital signs
Time frame: Day 9
1 secondary outcome
To assess the efficacy of LEO 29102 cream in the treatment of AD
Time frame: Day 9
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.
- 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.
Kahlid Aboufarha principal investigator
PRA Health Sciences
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 29102 cream in people with Atopic Dermatitis, run by LEO Pharma at 1 site in Netherlands.
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 11 inclusion and 0 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 Netherlands. 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?
Adverse events, laboratory testing, ECG, vital signs (time frame: Day 9). 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.