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Phase 2 N=24 Randomized Single-blind Other

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

Psoriasis Vulgaris

Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline — -6.00; -4.96; -1.88; -5.25 Scores on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
LEO90100 cutaneous spray, ointment (Drug); LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate (Drug); LEO 90100 cutaneous spray, ointment, vehicle (Drug); Daivobet® ointment (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
LEO Pharma
Primary completion
Jun 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline
-6.00; -4.96; -1.88; -5.25
SECONDARY
Change in Clinical Sign Scores
-1.75; -1.44; -0.56; -1.50; -2.13; -2.02
SECONDARY
Changes in Total Clinical Score (TCS) by Visit
-0.63; -0.77; -0.46; -0.73; -2.08; -1.83
SECONDARY
Change From Baseline in Echo-poor Band Thickness at End of Treatment
-0.57; -0.45; -0.12; -0.46
SECONDARY
Changes in Total Skin Thickness
-0.81; -0.66; -0.23; -0.62; -0.37; -0.28

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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 or Grenz ray therapy (4 weeks)
  • UVB (2 weeks)
  • 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
  • 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
  • Subjects using emollients on the target plaques within one week before randomisation and during the study
  • 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
  • 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
  • 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 products
  • Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis
  • Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two weeks preceding the screening visi
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01347255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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