Psoriasis VulgarisPhase 1NCT01580488

A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

A Phase 1 study testing B LEO 35299 20 mg/g cream, C LEO 35299 20 mg/g cream and E LEO 35299 10 mg/g solution in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate the anti-psoriatic effect of LEO 35299 in different formulations, compared to Daivonex® ointment and Daivonex® ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis Vulgaris
What is being tested?: B LEO 35299 20 mg/g cream, C LEO 35299 20 mg/g cream and E LEO 35299 10 mg/g solution
How many people: 24 participants
Where: 1 siteFrance
Study dates: Apr 2012to Jun 2012
Phase: Phase 1
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
Age 18 years or above.
Males, or females of non-child bearing potential.
Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (Baseline).

Who cannot join

Male subjects who are not willing to use a local contraception (such as condom) from the time of study entry and for three months following the last study drug application.
Female subjects who are pregnant, of child-bearing potential or who are breast feeding.
Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months(adalimumab, alefacept, infliximab), 4 months(ustekinumab) or 4 weeks/5 half-lives (which-ever islonger) for experimental biological products prior to randomisation and during the study.
Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immune suppressants) within the 4-week period prior to randomisation and during the study.
Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study:
Potent or very potent (WHO group III-IV) corticosteroids.

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Subjects using of phototherapy within the following time periods prior to randomisation and during the study:
PUVA (4 weeks)
UVB (2 weeks)
Subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study:
WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
Topical retinoids
Vitamin D analogues
Topical immunomodulators (e.g. macrolides)
Anthracen derivatives
Tar,
Salicylic acid.
Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history and/or subject interview
Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments)
Subjects with current participation in any other interventional clinical, based on interview of the subject

Trial locations and contacts

1 site in 1 country.

France1 site

Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière
Nice, 06202

Other trials in France

About this study

Conditions: Psoriasis Vulgaris
Being tested: B LEO 35299 20 mg/g cream, C LEO 35299 20 mg/g cream, E LEO 35299 10 mg/g solution, F LEO 35299 10 mg/g solution, Daivonex® ointment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

B LEO 35299 20 mg/g creamDrug
once daily application, 3 weeks
C LEO 35299 20 mg/g creamDrug
once daily application, 3 weeks
E LEO 35299 10 mg/g solutionDrug
once daily application, 3 weeks
F LEO 35299 10 mg/g solutionDrug
once daily application, 3 weeks
Daivonex® ointmentDrug
once daily application, 3 weeks
Daivonex® ointment vehicleDrug
once daily application, 3 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Total Clinical Score From Baseline to Day 22
Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. Total Clinical Score range from 0 (all symptoms absent) to 9 (all symptoms severe)
Measured: Baseline to Day 22

Secondary outcomes (5)

Change in Erythema From Baseline to Day 22
Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to Day 22
Change in Infiltration From Baseline to Day 22
Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to Day 22
Change in Scaling From Baseline to Day 22
Investigator's rating of the clinical appearance of scaling . Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to Day 22
Change in Lesion Thickness From Baseline to Day 22
Change in total skin thickness measured by ultrasound from baseline to end of treatment
Measured: Baseline to Day 22
Change in Skin Thickness From Baseline to Day 22
Change in skin thickness - echo-poor band measured by ultrasound from baseline to end of treatment
Measured: Baseline to Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Jun 2012

First posted19 Apr 2012 (estimated)
Study startApr 2012
Primary completionJun 2012
Study completionJun 2012

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 Psoriasis VulgarisStudies 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: Not applicable
Intervention model: Single group
Masking: Single blind
Who is masked: Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01580488
Sponsor's protocol ID: PLQ-008
Other IDs: 2011-005349-11
Status last verified: Nov 2013
First submitted: 16 Apr 2012
Last updated: 12 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris
Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Psoriasis, Psoriasis; Plaque
RecruitingPhase 1
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
Psoriasis Vulgaris

All Psoriasis Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris
ClinicalTrials.gov ID: NCT01580488
Acronym / sponsor ID: PLQ-008
Conditions: Psoriasis Vulgaris
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 19 Apr 2012 (estimated)
Results: Posted 30 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind (investigator)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
Age 18 years or above.
Males, or females of non-child bearing potential.
Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (Baseline).

Key exclusion criteria (21 listed)

Male subjects who are not willing to use a local contraception (such as condom) from the time of study entry and for three months following the last study drug application.
Female subjects who are pregnant, of child-bearing potential or who are breast feeding.
Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months(adalimumab, alefacept, infliximab), 4 months(ustekinumab) or 4 weeks/5 half-lives (which-ever islonger) for experimental biological products prior to randomisation and during the study.
Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immune suppressants) within the 4-week period prior to randomisation and during the study.
Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study:

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
B LEO 35299 20 mg/g creamonce daily application, 3 weeks	Drug	–
C LEO 35299 20 mg/g creamonce daily application, 3 weeks	Drug	–
E LEO 35299 10 mg/g solutiononce daily application, 3 weeks	Drug	–
F LEO 35299 10 mg/g solutiononce daily application, 3 weeks	Drug	–
Daivonex® ointmentonce daily application, 3 weeks	Drug	–
Daivonex® ointment vehicleonce daily application, 3 weeks	Drug	–

Primary outcome

Change in the Total Clinical Score From Baseline to Day 22
Time frame: Baseline to Day 22
Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. Total Clinical Score range from 0 (all symptoms absent) to 9 (all symptoms severe)

5 secondary outcomes

Change in Erythema From Baseline to Day 22
Time frame: Baseline to Day 22
Change in Infiltration From Baseline to Day 22
Time frame: Baseline to Day 22
Change in Scaling From Baseline to Day 22
Time frame: Baseline to Day 22
Change in Lesion Thickness From Baseline to Day 22
Time frame: Baseline to Day 22
Change in Skin Thickness From Baseline to Day 22
Time frame: Baseline to Day 22

Results and safety

Results posted to the registry on 30 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	24	23

Primary outcome: Change in the Total Clinical Score From Baseline to Day 22

Time frame: Baseline to Day 22. Mean (Standard Deviation). Unit: units on a scale

Measure	B LEO 35299 20 mg/g n = 24	C LEO 35299 20 mg/g n = 24	E LEO 35299 10 mg/g n = 24	F LEO 35299 10 mg/g n = 24	Daivonex® Ointment: Calcipotriol 50 mcg/g Ointment n = 24	Daivonex® Ointment n = 24
Value	-2.8 (1.5)	-1.9 (1.5)	-1.5 (1.5)	-1.8 (1.7)	-4.0 (1.5)	-3.3 (1.5)

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
B LEO 35299 20 mg/g	0 of 24 (0%)	0 of 24 (0%)	Not reported
C LEO 35299 20 mg/g	0 of 24 (0%)	0 of 24 (0%)	Not reported
E LEO 35299 10 mg/g	0 of 24 (0%)	0 of 24 (0%)	Not reported
F LEO 35299 10 mg/g	0 of 24 (0%)	0 of 24 (0%)	Not reported
Daivonex® Ointment: Calcipotriol 50 mcg/g Ointment	0 of 24 (0%)	2 of 24 (8.3%)	Not reported
Daivonex® Ointment	0 of 24 (0%)	1 of 24 (4.2%)	Not reported

Limitations and caveats (from the sponsor): This was an exploratory study in which each of the 24 subjects received all 6 treatments on 2 cm diameter dermal test sites. Regarding Adverse Events, only local dermal reactions could be potentially attributed to a specific treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Psoriasis Vulgaris

Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris
Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Psoriasis, Psoriasis; Plaque
RecruitingPhase 1
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
Psoriasis Vulgaris

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.

Catherine Queille-Roussel, MD principal investigator

Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière 06202 Nice Cedex 3, France

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 B LEO 35299 20 mg/g cream, C LEO 35299 20 mg/g cream and E LEO 35299 10 mg/g solution in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in France.

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 21 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 12 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 1 site in France. 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. 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?

Yes. Results are posted in the registry (first posted 30 Dec 2013). 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?

Change in the Total Clinical Score From Baseline to Day 22 (time frame: Baseline to Day 22). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01580488.

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 12 Mar 2025.