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Psoriasis VulgarisPhase 1NCT01466478

An Exploratory Psoriasis Plaque Test Study With LEO 29102 Plus Calcipotriol, Ointment, in Psoriasis Vulgaris

A Phase 1 study testing Ointment A: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment, Ointment B: LEO 29102 2.5 mg/g ointment and Ointment C: Calcipotriol 50 µg/g 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
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Trial summary

The purpose of the study is to compare the 3 ointment formulations containing LEO 29102 plus calcipotriol and Daivonex® ointment and Diprosone® ointment and to compare LEO 29102 plus calcipotriol to LEO 29102 alone and to calcipotriol alone in the same ointment vehicle, using the psoriasis plaque test modified from… 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?
Ointment A: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment, Ointment B: LEO 29102 2.5 mg/g ointment and Ointment C: Calcipotriol 50 µg/g ointment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteFrance
Study dates
Nov 2011to Dec 2011
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 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 has to provide signed and dated informed consent before any study related activities are carried out.
  • Age 18 years or above.
  • Either sex.
  • All skin types.
  • Outpatients with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 7 different products.
  • Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (Baseline).
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  • Subjects with psoriasis lesions (plaques) assessed by a Total Clinical Score (sum of scores of erythema, scaling and infiltration) of 4 to 9 inclusive but each individual item ≥ 1.
  • Subjects willing and able to follow all the study procedures and complete the whole study.
  • Subjects affiliated to a social security system.
  • Female subjects of childbearing potential using a reliable method of contraception for at least 1 month before the study start and during the course of the study (e.g., oral contraceptive pill, intrauterine device, contraceptive patches, implantable contraception, condoms) or females of non childbearing potential (i.e. postmenopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral ovariectomy or tubal section/ligation).
  • Female with a negative urine pregnancy test at Visit 1 (screening visit).

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 (4 weeks),
  • UVB (2 weeks).
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  • 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.
  • 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 using emollients on the target plaques within one week before randomisation and during the study.
  • Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to the 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 and/or subject interview.
  • 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 product(s).
  • Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis on the test areas.
  • 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

  • CPCAD - Centre de Pharmacologie Clinique Appliquée à la Dermatologie

    Nice, 06202

Other trials in France

About this study

Official title: A Phase I Exploratory Study Evaluating 3 Formulations of LEO 29102 Plus Calcipotriol, Ointment, LEO 29102 Ointment, Calcipotriol Ointment, Daivonex® Ointment and Diprosone® Ointment in the Treatment of Psoriasis

The purpose of the study is to compare the 3 ointment formulations containing LEO 29102 plus calcipotriol and Daivonex® ointment and Diprosone® ointment and to compare LEO 29102 plus calcipotriol to LEO 29102 alone and to calcipotriol alone in the same ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Being tested
Ointment A: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment, Ointment B: LEO 29102 2.5 mg/g ointment, Ointment C: Calcipotriol 50 µg/g ointment, Ointment D: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment, Ointment G: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment

What participants receive

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

  • Ointment A: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointmentDrug

    once daily application, 4 weeks

  • Ointment B: LEO 29102 2.5 mg/g ointmentDrug

    once daily application, 4 weeks

  • Ointment C: Calcipotriol 50 µg/g ointmentDrug

    once daily application, 4 weeks

  • Ointment D: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointmentDrug

    once daily application, 4 weeks

  • Ointment G: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointmentDrug

    once daily application, 4 weeks

  • Daivonex® ointmentDrug

    once daily application, 4 weeks

  • Diprosone® ointmentDrug

    once daily application, 4 weeks

Study groups in NCT01466478
Study groupRoleWhat they receive
LEO 29102 plus calcipotriolExperimentalNot described
Receives: Drug: Ointment A: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment; Drug: Ointment B: LEO 29102 2.5 mg/g ointment; Drug: Ointment C: Calcipotriol 50 µg/g ointment; Drug: Ointment D: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment; Drug: Ointment G: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment; Drug: Daivonex® ointment; Drug: Diprosone® ointment

What is being measured

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

  1. Change from baseline to end of treatment in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration).

    TCS range from 0 (all symptoms absent) to 9 (all symptoms severe)

    Measured: 4 weeks

Secondary outcomes (3)

  1. Clinical criteria: - Change from baseline in single clinical symptom score: erythema, scaling, infiltration at end of treatment and individual visits, - Change from baseline in Total Clinical Score (TCS) at individual visits.

    Measured: 4 weeks

  2. Ultrasonography: Change from baseline to end of treatment in lesion thickness (total and echo-poor band) measured by ultrasound.

    Measured: 4 weeks

  3. NIR spectroscopy: Change from baseline to Day 15 and end of treatment in the ratio between the peaks at 6900 cm-1 and at 5200 cm-1, the width of the peak at 6900 cm-1 and the calculated severity score

    Measured: 4 weeks

Timeline

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

  1. First posted8 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionDec 2011
  4. Study completionDec 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 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
NCT01466478
Sponsor's protocol ID
PLQ-007
Other IDs
2011-003058-25
Status last verified
Oct 2013
First submitted
26 Oct 2011
Last updated
24 Feb 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ointment A: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment, Ointment B: LEO 29102 2.5 mg/g ointment and Ointment C: Calcipotriol 50 µg/g 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 11 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 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 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?

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?

Change from baseline to end of treatment in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration). (time frame: 4 weeks). 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 NCT01466478.

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.

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