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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01347255
First received: May 3, 2011
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Psoriasis Vulgaris
Drug: LEO90100 cutaneous spray, ointment
Drug: Daivobet®/Taclonex® ointment
Drug: LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate
Drug: LEO 90100 cutaneous spray, ointment, vehicle
Drug: Daivobet® ointment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Official Title: A Psoriasis Plaque Test Study With LEO 90100 Cutaneous Spray, Ointment, in Psoriasis Vulgaris

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Absolute change in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration) at end of treatment compared to baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    TCS range from 0 (all symptoms absent) to 9 (all symptoms severe)


Secondary Outcome Measures:
  • Change in clinical symptom scores [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Absolute change in single clinical symptom score:

    erythema, scaling, infiltration at end of treatment and individual visits compared to baseline


  • Changes in Total Clinical Score (TCS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Change in Total Clinical Score (TCS) at individual visits compared to baseline

  • Treatment profile [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Difference between treatment profiles over time

  • Changes in lesion tickness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Change in lesion thickness measured by ultrasound measured by ultrasound at end of treatment and individual visits compared to baseline


Enrollment: 24
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LEO 90100 cutaneous spray ointment Drug: LEO90100 cutaneous spray, ointment
once daily application, 4weeks
Drug: Daivobet®/Taclonex® ointment
once daily application, 4weeks
Drug: LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate
once daily application, 4 weeks
Drug: LEO 90100 cutaneous spray, ointment, vehicle
once daily application, 4weeks
Drug: Daivobet® ointment
once daily application, 4weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
  2. 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
  3. 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
  4. 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)
  5. 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
  6. 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
  7. Subjects using emollients on the target plaques within one week before randomisation and during the study
  8. 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
  9. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
  10. Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history
  11. 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
  12. 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
  13. 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)
  14. 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)
  15. Subjects with current participation in any other interventional clinical trial, based on interview of the subject
  16. Subjects with known or suspected hypersensitivity to component(s) of the investigational products
  17. Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis
  18. Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two weeks preceding the screening visit
  19. Subjects impossible to contact in case of emergency
  20. 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)
  21. Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomisation
  22. Subjects under guardianship, hospitalized in a public or private institution, for a reason other than the research or subject deprived of freedom
  23. Subjects previously randomised in this trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347255

Locations
France
Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
Nice, France, Cedex 3
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Catherine Queille-Roussel, MD Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital l'Archet 2, 06202 Nice Cedex 3, France
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01347255     History of Changes
Other Study ID Numbers: LEO 90100-01, 2011-000153-23
Study First Received: May 3, 2011
Last Updated: October 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014