AzTrials
AzTrials

Psoriasis VulgarisPhase 2NCT01347255

A Psoriasis Plaque Test Study With LEO 90100 Cutaneous Spray, Ointment, in Psoriasis Vulgaris

A Phase 2 study testing LEO90100 cutaneous spray, ointment and Daivobet® ointment 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
Search all trials

Trial summary

The purpose of the study is to evaluate the anti-psoriatic effect of LEO 90100 cutaneous spray ointment, 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?
LEO90100 cutaneous spray, ointment and Daivobet® ointment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteFrance
Study dates
May 2011to Jun 2011
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects having signed and dated an informed consent
  • Age 18 years or above
  • Either sex
  • All skin types
  • Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk.

Who cannot join

  • Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, 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 is longer)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, immunosuppressants) within the 4- week period prior to randomisation and during the study
  • Use of phototherapy within the following time periods prior to randomisation and during the study:
  • PUVA or Grenz ray therapy (4 weeks)
  • UVB (2 weeks)
Show all 33Show fewer
  • Subjects using one of the following topical drugs within 4 weeks prior to randomisation and during the study:
  • Potent or very potent (WHO group III-IV) corticosteroids
  • Subjects using one of the following topical drugs for the treatment of psoriasis within 2 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. calcineurin inhibitors)
  • Anthracen derivatives
  • Tar
  • Salicylic acid
  • Subjects using emollients on the target plaques within one week before randomisation and during the study
  • Initiation of, or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to randomisation and during the study
  • 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
  • Subjects with any of the following conditions present on the test area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin
  • Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas
  • History of any severe disease or serious current condition (based on subject interview and/or results of screening physical examination) which, in the opinion of the Investigator, would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results or the study course (e.g. cancer, severe cardiopathy, severe renal insufficiency, severe hepatic insufficiency)
  • 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 trial, based on interview of the subject
  • Subjects with known or suspected hypersensitivity to component(s) of the investigational products
  • Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis
  • Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two weeks preceding the screening visit
  • Subjects impossible to contact in case of emergency
  • Subjects who are known or, in the opinion of the investigator, are unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
  • Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomisation
  • Subjects under guardianship, hospitalized in a public or private institution, for a reason other than the research or subject deprived of freedom
  • Subjects previously randomised in this trial

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)

    Nice, Cedex 3

Other trials in France

About this study

The purpose of the study is to evaluate the anti-psoriatic effect of LEO 90100 cutaneous spray ointment, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Being tested
LEO90100 cutaneous spray, ointment, LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate, LEO 90100 cutaneous spray, ointment, vehicle, Daivobet® ointment

What participants receive

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

  • LEO90100 cutaneous spray, ointmentDrug

    once daily application, 4 weeks

  • LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionateDrug

    once daily application, 4 weeks

  • LEO 90100 cutaneous spray, ointment, vehicleDrug

    once daily application, 4 weeks

  • Daivobet® ointmentDrug

    Also called Taclonex® ointment

    once daily application, 4 weeks

Study groups in NCT01347255
Study groupRoleWhat they receive
LEO 90100 cutaneous spray ointmentExperimentalLEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
Receives: Drug: LEO90100 cutaneous spray, ointment
LEO 90100 Cutaneous Spray, Ointment, Vehicle w. BetamethasoneActive comparatorVehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
Receives: Drug: LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate
LEO 90100 Cutaneous Spray, Ointment, VehiclePlacebo comparatorLEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
Receives: Drug: LEO 90100 cutaneous spray, ointment, vehicle
Daivobet® OintmentActive comparatorCalcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
Receives: Drug: Daivobet® ointment

What is being measured

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

  1. Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline

    TCS range from 0 (all signs absent) to 9 (all signs severe).

    Measured: Day 1 (Baseline)/Day 29

Secondary outcomes (4)

  1. Change in Clinical Sign Scores

    Absolute change in score of each clinical sign (erythema, scaling, infiltration) at end of treatment (Day 29) and at individual visits (Days 4, 8, 11, 15, 18, 22, and 25) compared to Baseline.

    The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale (range 0 (no evidence) to 3 (severe)).

    Negative changes in mean score represent improvement.

    Measured: Baseline and Days 4, 8, 11, 15, 18, 22, 25, and 29 (End of Treatment)

  2. Changes in Total Clinical Score (TCS) by Visit

    Change in Total Clinical Score (TCS; range from 0 (all signs absent) to 9 (all signs severe)) at individual visits (Days 4, 8, 11, 15, 22, and 25) compared to baseline.

    Measured: Baseline and Days 4, 8, 11, 15, 18, 22, 25

  3. Change From Baseline in Echo-poor Band Thickness at End of Treatment

    Change in echo-poor band thickness from baseline to end of treatment, measured by ultrasound

    Measured: Baseline and Day 29

  4. Changes in Total Skin Thickness

    Change in total skin thickness measured by ultrasound at end of treatment (Day 29) and individual visits (Days 8, 15, and 22) compared to baseline

    Measured: Baseline and Days 8, 15, 22, and 29.

Timeline

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

  1. First posted4 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

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
Other
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01347255
Sponsor's protocol ID
LEO 90100-01
Other IDs
2011-000153-23
Status last verified
Jul 2016
First submitted
3 May 2011
Last updated
7 Mar 2025
Data monitoring committee
No
Individual data sharing
No

Publications

  • Queille-Roussel C, Olesen M, Villumsen J, Lacour JP. Efficacy of an innovative aerosol foam formulation of fixed combination calcipotriol plus betamethasone dipropionate in patients with psoriasis vulgaris. Clin Drug Investig. 2015 Apr;35(4):239-45. doi: 10.1007/s40261-015-0269-7.

    PubMed 25708531

  • Queille-Roussel C, Olesen M, Villumsen J, Lacour JP. Antipsoriatic effect of a novel aerosol foam formulation of the fixed combination calcipotriene plus betamethasone dipropionate in patients with psoriasis, using a modified psoriasis plaque test. Semin Cutan Med Surg. 2015;34 S1:PA-10.

  • Hollesen Basse L, Olesen M, Lacour J, Queille-Roussel C. Enhanced in vitro skin penetration and antipsoriatic effect of fixed combination calcipotriol plus betamethasone dipropionate in an innovative foam vehicle. J Invest Dermatol. 2014;134:S33(abst 192).

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LEO90100 cutaneous spray, ointment and Daivobet® ointment 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 5 inclusion and 33 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 7 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. 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 24 Feb 2016). 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 Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline (time frame: Day 1 (Baseline)/Day 29). 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 NCT01347255, which also lists 3 linked publications.

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 7 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in