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Psoriasis VulgarisPhase 2NCT00764751

Efficacy and Safety of LEO 19123 Cream in the Treatment of Psoriasis Vulgaris

A Phase 2 study testing LEO 19123 Cream (calcipotriol plus LEO 80122) and Dovonex® cream in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in Canada.

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

This study will compare the efficacy and safety of once daily treatment of LEO 19123 cream versus Dovonex® cream (applied twice daily) and versus LEO 19123 cream vehicle alone (applied twice daily) in subjects with psoriasis vulgaris. Subject will be treated for 4 weeks. 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?
LEO 19123 Cream (calcipotriol plus LEO 80122) and Dovonex® cream
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
1 siteCanada
Study dates
Sep 2008to Jan 2009
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

  • Signed and dated informed consent to be obtained prior to any trial related procedure, including washout.
  • Clinical diagnosis of psoriasis vulgaris involving trunk and/or arms and/or legs with a symmetrical distribution amenable to treatment with a maximum of 50 g/week of topical medication on each side of the body. At Visit 1, there should not be a difference between the right and left side of more than 1 for each of the PASI criteria (redness, thickness and scaliness).
  • A minimum PASI score for extent of 2 on each side in at least one body region (i.e. psoriasis affecting at least 10% of left and right arm, and/or 10% of left and right side of the trunk, and/or 10% of left and right leg).
  • Disease severity graded mild, moderate, severe or very severe according to the Investigator's global assessment (IGA) of disease severity on each side of the body. The assessment should be the same for both sides of the body.
  • Age 18 years or above
  • Male subjects, or females of non-childbearing potential (i.e. surgically sterile or at least two years postmenopausal)
  • Attending a hospital outpatient clinic or the private practice of a dermatologist

Who cannot join

  • Subjects using systemic treatments with biological therapies with a possible effect on psoriasis vulgaris within 12 weeks prior to randomisation (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab)
  • Systemic treatment with all other therapies, besides biologics, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 4 weeks prior to randomisation (inhaled or intranasal steroids for asthma or rhinitis may be used)
  • PUVA or Grenz ray therapy within 4 weeks prior to randomisation
  • UVB therapy within 2 weeks prior to randomisation
  • Any topical treatment (except for emollients) of the trunk/limbs (except on flexures) within 2 weeks prior to randomisation
  • Topical treatment for other relevant skin disorders on the face and flexures (e.g., facial and flexural psoriasis, eczema) with potent or very potent (WHO group III-IV) corticosteroids, vitamin D analogues or retinoids within 2 weeks prior to randomisation
Show all 17Show fewer
  • Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with very potent (WHO group IV) corticosteroids, vitamin D analogues or retinoids within 2 weeks prior to randomisation
  • Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, ACE inhibitors, anti-malaria drugs, lithium) within 2 weeks prior to randomisation
  • 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
  • Subjects with current participation in any other interventional clinical trial
  • Subjects with any of the following conditions present on the treatment area: eczematous skin, atopic dermatitis, clinical infection, ulcers and wounds
  • Subjects with a history of serious allergy, allergic skin rash or sensitivity to any component of the investigational products or formulations being tested
  • Subjects with positive hepatitis B, C or HIV
  • Known or suspected severe renal insufficiency or severe hepatic disorders
  • Known or suspected disorders of calcium metabolism associated with hypercalcaemia
  • Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
  • Planned exposure to the sun during the study that may affect psoriasis vulgaris (i.e., normal lifestyle outdoor activities are permitted but deliberate exposure to sunlight or artificial ultraviolet light should be avoided)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • UltraNova Skincare

    Barrie, Ontario, L4M 6L2

Other trials in Canada

About this study

Official title: LEO 19123 Cream in the Treatment of Psoriasis Vulgaris

This study will compare the efficacy and safety of once daily treatment of LEO 19123 cream versus Dovonex® cream (applied twice daily) and versus LEO 19123 cream vehicle alone (applied twice daily) in subjects with psoriasis vulgaris. Subject will be treated for 4 weeks. All subjects will apply LEO 19123 cream to psoriasis lesions on the left or right side of the body and either Dovonex® cream or cream vehicle to lesions on the other side.

Being tested
LEO 19123 Cream (calcipotriol plus LEO 80122), Dovonex® cream, Cream vehicle

What participants receive

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

  • LEO 19123 Cream (calcipotriol plus LEO 80122)Drug

    Once daily application

  • Dovonex® creamDrug

    Twice daily application

  • Cream vehicleDrug

    Twice daily application

Study groups in NCT00764751
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: LEO 19123 Cream (calcipotriol plus LEO 80122)
2Active comparatorNot described
Receives: Drug: Dovonex® cream
3Placebo comparatorNot described
Receives: Drug: Cream vehicle

What is being measured

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

  1. The Percentage Change in PASI (Psoriasis Area Severity Index)

    The following formula was used to calculate the PASI for each side of the body:

    Upper extremities: 0.2 (R + T+ S) E = X Trunk: 0.3 (R + T+ S) E = Y Lower extremities 0.4 (R + T+ S) E = Z

    where: R = score for redness T = score for thickness S = score for scaliness E = score for extent

    The sum of X + Y + Z gives the total PASI, which can range from 0 to 64.8. The PASI used in this study is modified to exclude assessment of the head, as study treatment was not used here.

    Measured: From baseline (Day 0) to end of treatment (Day 28)

Secondary outcomes (7)

  1. Investigator's Global Assessment of Disease Severity

    At all visits the (sub)investigator made a global assessment of the disease severity for psoriasis on the left and right side, respectively, of the body by use of the 6-point scale below. These assessments were to represent the average lesion severity on the left and right side, respectively. These assessments were to be based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit.

    Clear Almost clear Mild Moderate Severe Very severe

    Measured: At end of treatment (Day 28)

  2. Participants With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity

    For subjects with a baseline (Visit 1) severity of moderate or worse, "controlled disease" is defined as "clear" or "almost clear" according to the Investigator's global assessment of disease severity. For subjects with a baseline (Visit 1) severity of mild, "controlled disease" is defined as "clear" according to the Investigator's global assessment of disease severity.

    Measured: At end of treatment (Day 28)

  3. Participant's Overall Assessment of Treatment Response

    The participant assessed the treatment response by use of the 6-point scale below.

    Worse Unchanged Slight improvement Moderate improvement Marked improvement Almost clear Cleared

    Measured: At end of treatment (Day 28)

  4. Participant's Assessment of Treatment Preference

    Measured: At end of treatment (Day 28)

  5. Participants With at Least 75% Reduction in PASI (PASI 75)

    Measured: From baseline (Day 0) to end of treatment (Day 28)

  6. Participants With at Least 50% Reduction in PASI (PASI 50)

    Measured: From baseline (Day 0) to end of treatment (day 28)

  7. The Absolute Change in PASI (Psoriasis Area Severity Index)

    The following formula was used to calculate the PASI for each side of the body:

    Upper extremities: 0.2 (R + T+ S) E = X Trunk: 0.3 (R + T+ S) E = Y Lower extremities 0.4 (R + T+ S) E = Z

    where: R = score for redness T = score for thickness S = score for scaliness E = score for extent

    The sum of X + Y + Z gives the total PASI, which can range from 0 to 64.8. The PASI used in this study is modified to exclude assessment of the head, as study treatment was not used here.

    Measured: From baseline to end of treatment (Day 28)

Timeline

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

  1. First posted2 Oct 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionDec 2008
  4. Study completionJan 2009

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00764751
Sponsor's protocol ID
LEO 19123-C24
Status last verified
Feb 2018
First submitted
1 Oct 2008
Last updated
7 Mar 2025
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LEO 19123 Cream (calcipotriol plus LEO 80122) and Dovonex® cream in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in Canada.

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 7 inclusion and 17 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 Canada. 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 6 May 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?

The Percentage Change in PASI (Psoriasis Area Severity Index) (time frame: From baseline (Day 0) to 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?

On the ClinicalTrials.gov record for NCT00764751.

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.

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