Atopic DermatitisPhase 1NCT01447758
Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis.
A Phase 1 study testing LEO 29102 in people with Atopic Dermatitis, run by LEO Pharma at 8 sites in Germany.
Trial summary
The purpose of this Phase Ib study is to investigate the safety, tolerability and pharmacokinetics of LEO 29102 2,5 mg/g cream when treating atopic dermatitis (AD) lesions from 10 up to 100% of the body surface area (BSA) twice daily (BID) for 7 days (Cohorts I, II, III) and from 10% up to 50% of BSA (bid) for 6 weeks… 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 8 sitesGermany
- Study dates
- Sep 2011to Mar 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of AD defined according to Hanifin and Rajka.
- Investigator Global Assessment scored as mild (2) to severe (4) AD.
- At screening, AD lesions amenable for treatment involving 10% to < 25% (Cohort I), 25% to < 50% (Cohort II), 50% to 100% (Cohort III) and 10% to < 50% (Cohort IV) of the total BSA.
- On Day -1, AD lesions amenable for treatment involving 10% to < 28% (Cohort I), 25% to < 55% (Cohort II), 50% to 100% (Cohort III) and 10% to < 55% (Cohort IV) of the total BSA.
- Adult male or female subjects, aged 18 to 65 years, inclusive.
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Klinik und Poliklinik für Dermatologie und Allergologie der Universität Bonn
Bonn, 53105
Universitätshautklinik Essen
Essen, 45122
Department of Dermatology, Johann Wolfgang Goethe-University
Frankfurt am Main, 60590
SRH Wald-Klinikum Gera gGmbH
Gera, 07584
Clinical Trial Center North
Hamburg, 20246
Medizinische Hochschule Hannover
Hanover, 30449
Universitätshautklinik Münster
Münster, 48149
About this study
Official title: Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis. A Multicentre, Prospective, Randomised Phase Ib Study in Subjects Investigating Safety,Tolerability and Pharmacokinetics of LEO 29102 Cream (2.5 mg/g) When Treating Atopic Dermatitis Lesions Twice Daily for 7 Days (Cohorts I, II and III) and 6 Weeks (Cohort IV)
The purpose of this Phase Ib study is to investigate the safety, tolerability and pharmacokinetics of LEO 29102 2,5 mg/g cream when treating atopic dermatitis (AD) lesions from 10 up to 100% of the body surface area (BSA) twice daily (BID) for 7 days (Cohorts I, II, III) and from 10% up to 50% of BSA (bid) for 6 weeks (Cohort IV). This trial will be performed in four cohorts. Cohort I, II and III includes patients with a larger BSA that increases from one cohort to the next. After each cohort (Cohort I, II)a blinded evaluation of the safety and tolerability data will assess whether a stepwise increase in the percentage of "to be treated BSA" is justified. Cohort IV will start dosing after finalisation of Cohort II and after submission of data from Cohort I and II to the national authority and IEC for review.
- Conditions
- Atopic Dermatitis
- Being tested
- LEO 29102, LEO 29102 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 29102Drug
Cream, 1,7mg/cm2 BSA, BID, 7 days In Cohort I, II and III, 6 weeks in Cohort IV
LEO 29102 Cream VehicleDrug
Cream, 1,7mg/cm2 BSA, BID, 7 days in Cohort I and II, 6 weeks in Cohort IV
| Study group | Role | What they receive |
|---|---|---|
| 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 Cream Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK profile - Cohort I, II, III
Cmax, AUC, Tmax
Measured: Predose, 1h, 2h, 4h, 6h, 12h, 13h, 14h, 16h, 18h, 24h (on day 1 and 7) and 36h, 48h, 72h (on day 7 only)
Tolerability and safety of LEO 29102 cream - Cohort I, II, III
Number of subjects with AEs and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate body temperature), ECG parameters, clinical laboratory, physical examination
Measured: 14 Days
PK profile - Cohort IV
Cmax, AUC, Tmax
Measured: Day 1, 14, 28, 42: Pre AM dose and 1h, 2h, 4h, 6h, 12h. Post AM dose, but prior to PM dose and 24 h, 36h, 48h, 72h after AM dose Day 42
Tolerability and safety of LEO 29102 cream - Cohort IV
Number of subjects with AEs and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate body temperature), ECG parameters, clinical laboratory, physical examination, SCORAD, EASI and IGA by stratum, treatment and visit.
Measured: 49 Days
Secondary outcomes (2)
Dermis concentration of LEO 29102 and its metabolites LEO 28386 and LEO 26989 after multiple topical applications in subjects with AD (Cohorts II and IV, Subgroup 1)
Measured: 10 Days for cohort II; 42 days for cohort IV, subgroup 1
Biomarkers in AD lesions before and after multiple topical applications in subjects with AD (Cohorts I and IV, Subgroup 2)
Measured: 10 Days for cohort I, 42 days for cohort IV, subgroup 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2013
- Study completionMar 2013
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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diamant Thaci, MD, Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447758
- Sponsor's protocol ID
- LEO 29102-C26
- Status last verified
- Apr 2013
- First submitted
- 13 Jul 2011
- 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
- Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis. A Multicentre, Prospective, Randomised Phase Ib Study in Subjects Investigating Safety,Tolerability and Pharmacokinetics of LEO 29102 Cream (2.5 mg/g) When Treating Atopic Dermatitis Lesions Twice Daily for 7 Days (Cohorts I, II and III) and 6 Weeks (Cohort IV)
- ClinicalTrials.gov ID
- NCT01447758
- Acronym / sponsor ID
- LEO 29102-C26
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 58 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 6 Oct 2011 (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 Phase Ib study is to investigate the safety, tolerability and pharmacokinetics of LEO 29102 2,5 mg/g cream when treating atopic dermatitis (AD) lesions from 10 up to 100% of the body surface area (BSA) twice daily (BID) for 7 days (Cohorts I, II, III) and from 10% up to 50% of BSA (bid) for 6 weeks (Cohort IV). This trial will be performed in four cohorts. Cohort I, II and III includes patients with a larger BSA that increases from one cohort to the next. After each cohort (Cohort I, II)a blinded evaluation of the safety and tolerability data will assess whether a stepwise increase in the percentage of "to be treated BSA" is justified. Cohort IV will start dosing after finalisation of Cohort II and after submission of data from Cohort I and II to the national authority and IEC for review.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEO 29102 2,5 mg/g cream | Experimental | Drug: LEO 29102 |
| LEO 29102 Cream Vehicle | Placebo comparator | Drug: LEO 29102 Cream Vehicle |
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 AD defined according to Hanifin and Rajka.
- Investigator Global Assessment scored as mild (2) to severe (4) AD.
- At screening, AD lesions amenable for treatment involving 10% to < 25% (Cohort I), 25% to < 50% (Cohort II), 50% to 100% (Cohort III) and 10% to < 50% (Cohort IV) of the total BSA.
- On Day -1, AD lesions amenable for treatment involving 10% to < 28% (Cohort I), 25% to < 55% (Cohort II), 50% to 100% (Cohort III) and 10% to < 55% (Cohort IV) of the total BSA.
- Adult male or female subjects, aged 18 to 65 years, inclusive.
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 29102Cream, 1,7mg/cm2 BSA, BID, 7 days In Cohort I, II and III, 6 weeks in Cohort IV | Drug | LEO 29102 2,5 mg/g cream |
| LEO 29102 Cream VehicleCream, 1,7mg/cm2 BSA, BID, 7 days in Cohort I and II, 6 weeks in Cohort IV | Drug | LEO 29102 Cream Vehicle |
Primary outcome
PK profile - Cohort I, II, III
Time frame: Predose, 1h, 2h, 4h, 6h, 12h, 13h, 14h, 16h, 18h, 24h (on day 1 and 7) and 36h, 48h, 72h (on day 7 only)
Cmax, AUC, Tmax
Tolerability and safety of LEO 29102 cream - Cohort I, II, III
Time frame: 14 Days
Number of subjects with AEs and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate body temperature), ECG parameters, clinical laboratory, physical examination
PK profile - Cohort IV
Time frame: Day 1, 14, 28, 42: Pre AM dose and 1h, 2h, 4h, 6h, 12h. Post AM dose, but prior to PM dose and 24 h, 36h, 48h, 72h after AM dose Day 42
Cmax, AUC, Tmax
Tolerability and safety of LEO 29102 cream - Cohort IV
Time frame: 49 Days
Number of subjects with AEs and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate body temperature), ECG parameters, clinical laboratory, physical examination, SCORAD, EASI and IGA by stratum, treatment and visit.
2 secondary outcomes
Dermis concentration of LEO 29102 and its metabolites LEO 28386 and LEO 26989 after multiple topical applications in subjects with AD (Cohorts II and IV, Subgroup 1)
Time frame: 10 Days for cohort II; 42 days for cohort IV, subgroup 1
Biomarkers in AD lesions before and after multiple topical applications in subjects with AD (Cohorts I and IV, Subgroup 2)
Time frame: 10 Days for cohort I, 42 days for cohort IV, subgroup 2
Results and safety
The study was stopped early. Results are not available in the source record.
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.
Diamant Thaci, MD principal investigator
Goethe University
8 sites 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 in people with Atopic Dermatitis, run by LEO Pharma at 8 sites 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 5 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: stopped early, 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 8 sites 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 was stopped early. Results are not available in the source record.
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?
PK profile - Cohort I, II, III (time frame: Predose, 1h, 2h, 4h, 6h, 12h, 13h, 14h, 16h, 18h, 24h (on day 1 and 7) and 36h, 48h, 72h (on day 7 only)). The study lists 4 primary outcomes in all. 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.