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Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Scalp Psoriasis

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LEO Pharma

Status and phase

Completed
Phase 3

Conditions

Psoriasis of Scalp

Treatments

Drug: Calcipotriol plus betamethasone dipropionate (LEO80185 gel)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00216840
MBL 0406 INT

Details and patient eligibility

About

The purpose of the study is to evaluate whether once daily topical treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle and calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis.

The primary response criterion is the number of patients with absence of disease and very mild disease after 8 weeks of treatment.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Scalp psoriasis amenable to topical treatment with a maximum of 100 g of medication per week
  • Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs
  • Extent of scalp psoriasis involving more than 10% of the total scalp area
  • Investigator's assessment of clinical signs of the scalp of at least 2 in one of the clinical signs, erythema, thickness and scaliness, and at least 1 in each of the other two clinical signs
  • Disease severity on the scalp graded as Mild, Moderate, Severe or Very severe according to the investigator's global assessment of disease severity

Exclusion criteria

  • PUVA or Grenz ray therapy within 4 weeks prior to randomisation
  • UVB therapy within 2 weeks prior to randomisation
  • Systemic treatment with biological therapies, with a possible effect on scalp psoriasis within 6 months prior to randomisation
  • Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation
  • Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation
  • Topical treatment of the face, trunk and/or limbs with very potent WHO group IV corticosteroids within 2 weeks prior to randomisation
  • Current diagnosis of erythrodermic, exfoliative or pustular psoriasis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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