AzTrials
AzTrials

Psoriasis VulgarisPhase 3NCT01188928

LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)

A Phase 3 study testing Calcipotriol plus betamethasone, Betamethasone-17,21-dipropionate and Calcipotriene in people with Psoriasis Vulgaris, run by LEO Pharma at 59 sites in United States.

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 this study is to compare the efficacy and safety of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension with the active components when used individually as monotherapy in the topical suspension vehicle (betamethasone dipropionate in the topical suspension vehicle… 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?
Calcipotriol plus betamethasone, Betamethasone-17,21-dipropionate and Calcipotriene
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,152 participants
Where
59 sitesUnited States
Study dates
Sep 2010to Mar 2011
Phase
Phase 3
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 obtained prior to any trial related activities (including any washout period).
  • Aged 18 years or above
  • Either sex
  • Any race or ethnicity
  • Attending a hospital outpatient clinic or the private practice of a board certified dermatologist.
  • Clinical diagnosis of stable plaque psoriasis vulgaris of at least 6 months duration involving the non-scalp regions of the body (trunk and/or limbs) amenable to treatment with a maximum of 100 g of topical medication per week.
Show all 11Show fewer
  • An investigator's global assessment of disease severity (IGA) of mild or moderate on the body (trunk and/or limbs) at Day 0 (Visit 1).
  • A minimum modified Psoriasis Area and Severity Index (PASI) score for extent of 2 in at least one body region (i.e. psoriasis affecting at least 10% of arms, and/or 10% of trunk, and/or 10% of legs)
  • Females of childbearing potential must have a negative pregnancy test at Day 0 (Visit 1).
  • Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner. The patients must have used the contraceptive method continually 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. 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

  • Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
  • etanercept - within 4 weeks prior to randomisation
  • adalimumab, alefacept, infliximab - within 2 months prior to randomisation
  • ustekinumab - within 4 months prior to randomisation
  • experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to randomisation
  • Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, cyclosporine and other immunosuppressants) within 4 weeks prior to randomisation.
Show all 22Show fewer
  • PUVA or Grenz ray therapy within 4 weeks prior to randomisation.
  • UVB therapy within 2 weeks prior to randomisation.
  • Any topical treatment of the trunk and/or limbs (except for emollients) 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 class 1- 5 corticosteroids or vitamin D analogues within 2 weeks prior to randomisation.
  • Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with class 1-5 corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation.
  • Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, anti-malarials, lithium, ACE inhibitors) during the study.
  • Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
  • Subjects with any of the following conditions present on the treatment area: 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, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, acne rosacea, ulcers and wounds.
  • Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
  • Known or suspected severe renal insufficiency or severe hepatic disorders.
  • Known or suspected hypersensitivity to component(s) of the investigational products.
  • Current participation in any other interventional clinical study.
  • 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 substance required a longer washout as defined above (e.g. biological treatments).
  • Planned excessive exposure to the sun during the study that may affect the psoriasis vulgaris.
  • Previously randomised in this study.
  • Females who are pregnant, have a positive pregnancy test at Day 0 (Visit 1), or are breast-feeding. Females of child-bearing potential wishing to become pregnant during the study, or not using an adequate method of contraception during the study.

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United States59 sites

  • Academic Dermatology Associates

    Albuquerque, New Mexico, 87106

  • Atlanta Dermatology, Vein & Research Center

    Alpharetta, Georgia, 30022

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • David Fivenson, MD Dermatology, PLC

    Ann Arbor, Michigan, 48103

  • Altman Dermatology Associates

    Arlington Hts, Illinois, 60005

  • Peachtree Dermatology Associates

    Atlanta, Georgia, 30327

  • Great Lakes Research Group, Inc

    Bay City, Michigan, 48706

  • Visions Clinical Research

    Boynton Beach, Florida, 33472

  • Glazer Dermatology

    Buffalo Grove, Illinois, 60089

  • Triangle Medical Research Associates, LLC

    Cary, North Carolina, 27518

  • Michigan Center for Research Corp.,

    Clinton Township, Michigan, 48038

  • J&S Studies, Inc.

    College Station, Texas, 77845

  • Dermatology Associates and Research

    Coral Gables, Florida, 33134

  • Division of Dermatology, Baylor Research Institute

    Dallas, Texas, 75246

  • Colorado Medical Research Center, Inc.

    Denver, Colorado, 80120

  • Horizons Clinical Research Center, LLC

    Denver, Colorado, 80220

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Psoriasis Treatment Center of Central NJ

    East Windsor, New Jersey, 08520

  • Anderson & Collins Clinical Research, Inc.

    Edison, New Jersey, 08817

  • Deaconess Clinic, Inc.

    Evansville, Indiana, 47713

  • Hudson Dermatology

    Evansville, Indiana, 47714

  • Hamzavi Dermatology

    Fort Gratiot, Michigan, 48059

  • Minnesota Clinical Study Center

    Fridley, Minnesota, 55432

  • Karl G. Heine, M. D. Dermatology

    Henderson, Nevada, 89052

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas, 71913

  • Centre for Clinical Studies

    Houston, Texas, 77030

  • Dawes Fretzin Clinical Research Group

    Indianapolis, Indiana, 46256

  • North Florida Dermatology Associates, PA

    Jacksonville, Florida, 32204

  • King-Maceyko Dermatology Associates

    Johnstown, Pennsylvania, 15905

  • DBA Torrance Clinical Research

    Lomita, California, 90717

  • Dermatology Specialists

    Louisville, Kentucky, 40202

  • Dermatologic Surgery Specialists, PC

    Macon, Georgia, 31217

  • International Dermatology Research, Inc.

    Miami, Florida, 33144

  • Horizon Research Group, Inc

    Mobile, Alabama, 36606

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Dermatology Specialists, Inc.

    Oceanside, California, 92056

  • Ameriderm Research

    Ormond Beach, Florida, 32174

  • Owensboro Dermatology Associates

    Owensboro, Kentucky, 42303

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210

  • Lawrence J. Green, MD, LLC

    Rockville, Maryland, 20850

  • Dermatology Research Center, Inc.

    Salt Lake City, Utah, 84117

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas, 78229

  • Progressive Clinical Research, P.A.

    San Antonio, Texas, 78229

  • Skin Surgery Medical Group, Inc.

    San Diego, California, 92117

  • Walter Nahm, MD, Ph.D., Inc

    San Diego, California, 92123

  • Coastal Medical Research Group, Inc.

    San Luis Obispo, California, 93401

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Dermatology Research Centers

    Santa Monica, California, 90404

  • Gwinnett Clinical Research Center, Inc

    Snellville, Georgia, 30078

  • Haber Dermatology and Cosmetic Surgery

    South Euclid, Ohio, 44118

  • Premier Clinical Research

    Spokane, Washington, 99204

  • Derm Research Center of New York

    Stony Brook, New York, 11790

  • Somerset Skin Centre

    Troy, Michigan, 48084

  • The Dermatology Group, PC

    Verona, New Jersey, 07044

  • Grekin Skin Institute

    Warren, Michigan, 48088

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: A Phase 3 Study Comparing Once Daily Treatment With Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension With Betamethasone 0.5 mg/g (as Dipropionate) in the Topical Suspension Vehicle, Calcipotriol 50 mcg/g in the Topical Suspension Vehicle and the Topical Suspension Vehicle Alone in Subjects With Psoriasis Vulgaris on Non-scalp Regions of the Body (Trunk and/or Limbs)

The purpose of this study is to compare the efficacy and safety of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension with the active components when used individually as monotherapy in the topical suspension vehicle (betamethasone dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension vehicle) and with the topical suspension vehicle alone in the treatment of psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs) in a large phase 3 study. This comparison will ensure a more informed assessment of the benefit/risk ratio of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension while also establishing the optimal treatment duration in psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs).

Being tested
Calcipotriol plus betamethasone, Betamethasone-17,21-dipropionate, Calcipotriene, Topical suspension vehicle

What participants receive

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

  • Calcipotriol plus betamethasoneDrug

    Topical suspension once daily for up to 8 weeks.

  • Betamethasone-17,21-dipropionateDrug

    Topical suspension once daily for up to 8 weeks.

  • CalcipotrieneDrug

    Topical suspension once daily for up to 8 weeks.

  • Topical suspension vehicleDrug

    Topical suspension once daily for up to 8 weeks.

Study groups in NCT01188928
Study groupRoleWhat they receive
LEO 80185ExperimentalCalcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
Receives: Drug: Calcipotriol plus betamethasone
BetamethasoneActive comparatorBetamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
Receives: Drug: Betamethasone-17,21-dipropionate
CalcipotriolActive comparatorCalcipotriol 50 mcg/g in the topical suspension vehicle
Receives: Drug: Calcipotriene
Topical suspension vehiclePlacebo comparatorThe topical suspension vehicle alone
Receives: Drug: Topical suspension vehicle

What is being measured

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

  1. Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4

    The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.

    Measured: 4 weeks

  2. Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8

    The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.

    Measured: week 8

Secondary outcomes (2)

  1. Mean Percentage Change in PASI From Baseline to Week 4

    At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.

    Measured: Baseline and 4 weeks

  2. Mean Percentage Change in PASI From Baseline to Week 8

    At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.

    Measured: Baseline and 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 posted26 Aug 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionMar 2011
  4. Study completionMar 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01188928
Sponsor's protocol ID
LEO 80185-G23
Status last verified
Dec 2016
First submitted
25 Aug 2010
Last updated
10 Mar 2025
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Calcipotriol plus betamethasone, Betamethasone-17,21-dipropionate and Calcipotriene in people with Psoriasis Vulgaris, run by LEO Pharma at 59 sites in United States.

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 22 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 10 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 59 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 9 Apr 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?

Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4 (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT01188928.

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 10 Mar 2025.

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

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in