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Psoriasis VulgarisPhase 2NCT01229098

Effect of LEO 80185 Gel on the HPA Axis and Calcium Metabolism in Subjects With Extensive Psoriasis Vulgaris

A Phase 2 study testing LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension) in people with Psoriasis Vulgaris, run by LEO Pharma at 10 sites 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

The purpose of this study is to evaluate the effect of once daily use of LEO 80185 gel on the hypothalamic-pituitary-adrenal (HPA) axis and calcium metabolism in subjects with extensive psoriasis vulgaris. 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 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
10 sitesCanada
Study dates
Oct 2010to Oct 2011
Phase
Phase 2
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

  • Signed and dated informed consent obtained following receipt of verbal and written information about the study prior to any trial related activities (including any wash-out period).
  • Age 18 years or above.
  • Either sex.
  • Any race or ethnicity.
  • Attending a hospital out-subject clinic or the private practice of a dermatologist for treatment of psoriasis vulgaris.
  • Clinical diagnosis of psoriasis vulgaris involving non scalp regions of the body (trunk and/or limbs) with or without involvement of the scalp.
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  • At SV2 and Day 0 (Visit 1) a clinical diagnosis of psoriasis vulgaris which is:
  • amenable to topical treatment with a maximum of 100 g of study medication per week, and
  • of an extent of between 15 and 30% of the body surface area (BSA) excluding psoriasis on the face, genitals or skin folds.
  • a disease severity on the trunk and/or limbs graded as at least moderate according to the investigator's global assessment (IGA)
  • Subjects with normal HPA axis function at SV2 including a serum cortisol concentration above 5 mcg/dL before ACTH challenge test and above 18 mcg/dL 30 minutes after ACTH challenge test.
  • Albumin-corrected serum calcium, below the upper reference limit at SV2.
  • Females of child-bearing potential must have a negative urine pregnancy test result at baseline Visit SV2 and must agree to use a highly effective method of contraception during the study. Highly effective methods are defined as ones which results in a low failure rate (less than 1% per year) such as progestin-only formulations (implants, injectables), some intra-uterine devices, or vasectomised partner. Subjects must have used the contraceptive method continuously for at least 1 month prior to the pregnancy test and must continue using the contraceptive method for at least 1 week after the last application of study medication (or until study visit FU2 if applicable). A female is defined as not of child-bearing potential if she is postmenopausal (12 months with no menses without an alternative medical cause), or surgically sterile (tubal ligation/section, hysterectomy or bilateral ovariectomy).
  • Able to communicate with the investigator and understand and comply with the requirements of the study.

Who cannot join

  • A history of serious allergy, allergic asthma or serious allergic skin rash
  • Known or suspected hypersensitivity to any medication (including ACTH/cosyntropin/tetracosactide) or to any component of the LEO 80185 gel or CORTROSYN.
  • Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2 and during the study.
  • Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on psoriasis vulgaris within the following time period prior to Day 0 (Visit 1) and during the study:
  • etanercept - within 4 weeks prior to Visit 1
  • adalimumab, alefacept, infliximab -within 2 months prior to Visit 1
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  • ustekinumab, briakinumab - within 4 months prior to Visit 1
  • experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1
  • Systemic treatment with therapies other than biologicals, with a possible effect on psoriasis vulgaris (e.g., retinoids, methotrexate, immunosuppressants) within 4 weeks prior to Visit 1 (Day 0) or during the study.
  • PUVA or Grenz ray therapy within 4 weeks prior to Visit 1 (Day 0) or during the study
  • UVB therapy within 2 weeks prior to Visit 1 (Day 0) or during the study.
  • Topical treatment with corticosteroids or vitamin D analogues (calcipotriol, calcitriol or tacalcitol) on any body location within 2 weeks prior to SV2 or during the study.
  • Any topical treatment of psoriasis vulgaris on the scalp or trunk and/or limbs (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 (Day 0) or during the study.
  • Oral calcium supplements, vitamin D supplements, antacids, thiazide and/or loop diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to SV2 and during the study. Note: Stable doses of oral vitamin D supplementation ≤400 IU/day is permitted provided there are no dose adjustments during the study period.
  • Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g., betablockers, antimalarials, lithium, ACE inhibitors) during the study.
  • Planned excessive exposure of treated areas to either natural or artificial sunlight (e.g. sunlamps etc.) during the study that may affect the psoriasis vulgaris.
  • Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to SV2 or during the study.
  • Cytochrome P450 3A4 (CYP 3A4) inducers (e.g., barbiturates, phenytoin, rifampicin) within 4 weeks prior to SV2 or during the study.
  • Systemic or topical cytochrome P450 3A4 (CYP 3A4) inhibitors (e.g., ketoconazole, itraconazole, metronidazole) within 4 weeks prior to SV2 or during the study. Topical ketoconazole within 2 weeks prior to SV2.
  • Hypoglycaemic sulfonamides within 4 weeks prior to the SV2 or during the study.
  • Antidepressant medications within 4 weeks prior to SV2 or during the study.
  • Not following nocturnal sleep patterns (e.g. night shift workers are excluded).
  • Known or suspected endocrine disorder that may affect the results of the ACTH challenge test.
  • Clinical signs or symptoms of Cushing's disease or Addison's disease.
  • Known or suspected diabetes mellitus.
  • Known or suspected cardiac disorders associated with abnormal QT intervals or rhythm disturbances including clinically significant bradycardia or tachycardia.
  • Known or suspected severe renal insufficiency or severe hepatic disorders.
  • Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
  • Any clinically significant abnormality following review of screening laboratory tests (blood and spot urine samples), physical examination or blood pressure/heart rate measurement performed at SV2.
  • Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
  • Any of the following conditions present on the study treatment areas: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds.
  • Other inflammatory skin diseases that may confound the evaluation of psoriasis vulgaris (e.g. seborrhoeic dermatitis, contact dermatitis and cutaneous mycosis).
  • Current participation in any other interventional clinical trial.
  • Previously enrolled in this trial (with the exception of subjects excluded due to hypocalcaemia prior to implementation of Consolidated Clinical Study Protocol 2).
  • Received any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within 4 weeks or 5 half-lives (whichever is longer) prior to SV1.
  • Known or suspected of not being able to comply with the trial protocol (e.g., alcoholism, drug dependency or psychotic state).
  • Females who are pregnant, have a positive urine pregnancy test at baseline Visit SV2, or are breast-feeding. Females of child-bearing potential and wishing to become pregnant during the study or not using an adequate method of contraception during the study.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Canada10 sites

  • Eastern Canada Cutaneous Research Associates Ltd.

    Halifax, Nova Scotia, B3H 1Z4

  • Dermsearch

    London, Ontario, N5X 2P1

  • Lynderm Research Inc.

    Markham, Ontario, L3P 1A8

  • Institute of Cosmetic and Laser Surgery

    Oakville, Ontario, L6J 7W5

  • Co-Medica Research Network Inc.

    Oshawa, Ontario, L1E 3C3

  • Oshawa Clinic

    Oshawa, Ontario, L1H 1B9

  • Alpha Clinical Research Centre

    St. John's, Newfoundland and Labrador, A1B 4S8

  • Newlab Clinical Research

    St. John's, Newfoundland and Labrador, A1C 2H5

  • Winnipeg Clinic

    Winnipeg, Manitoba, R3C 0N2

  • Dermadvances Research

    Winnipeg, Manitoba, R3C 1R4

Other trials in Canada

About this study

Official title: A Phase 2 Maximal Use Systemic Exposure Study Evaluating the Safety and Efficacy of Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Gel Applied Once Daily in Subjects With Extensive Psoriasis Vulgaris on the Scalp and Non-scalp Regions of the Body (Trunk and/or Limbs)

The purpose of this study is to evaluate the effect of once daily use of LEO 80185 gel on the hypothalamic-pituitary-adrenal (HPA) axis and calcium metabolism in subjects with extensive psoriasis vulgaris.

Being tested
LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)

What participants receive

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

  • LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)Drug

    LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel) Topical suspension applied once daily for up to 8 weeks

Study groups in NCT01229098
Study groupRoleWhat they receive
LEO 80185ExperimentalNot described
Receives: Drug: LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)

What is being measured

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

  1. Safety

    • Subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge [ Time Frame: Week 4 and week 8 ] [ Designated as safety issue: Yes ]
    • Change in albumin-corrected serum calcium from baseline [ Time Frame: Week 4 and week 8 ] [ Designated as safety issue: Yes ]
    • Change in 24-hour urinary calcium excretion from baseline [ Time Frame: Week 4 and week 8 ] [ Designated as safety issue: Yes ]
    • Change in urinary calcium:creatinine ratio from baseline [ Time Frame: Week 4 and week 8 ] [ Designated as safety issue: Yes ]

    Measured: Up to 8 weeks

Secondary outcomes (1)

  1. Efficacy

    • Subjects with "Controlled disease" (i.e., "Clear" or "Almost clear") according to the investigator's global assessment of disease severity [ Time Frame: Weeks 2, 4, 8 ] [ Designated as safety issue: No ]
    • Pharmacokinetic parameters for calcipotriol, betamethasone dipropionate and any metabolites.

    Measured: Up to 8 weeks

Timeline

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

  1. First posted27 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionSep 2011
  4. Study completionOct 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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01229098
Sponsor's protocol ID
LEO 80185-G24
Status last verified
Mar 2015
First submitted
26 Oct 2010
Last updated
24 Feb 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Silver S, Tuppal R, Gupta AK, Clonier F, Olesen M, Leeder R, Taraska V. Effect of calcipotriene plus betamethasone dipropionate topical suspension on the hypothalamic-pituitary-adrenal axis and calcium homeostasis in subjects with extensive psoriasis vulgaris: an open, non-controlled, 8-week trial. J Drugs Dermatol. 2013 Aug;12(8):882-7.

    PubMed 23986161

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension) in people with Psoriasis Vulgaris, run by LEO Pharma at 10 sites 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 14 inclusion and 37 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 10 sites 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. 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?

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?

Safety (time frame: Up to 8 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 NCT01229098, which also lists 1 linked publication.

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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