Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis
Summary
The purpose of this study is to evaluate whether once daily 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, calcipotriol 50 mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis.
The primary outcome is the proportion of patients with absence of disease or very mild disease after 8 weeks of treatment.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Psoriasis of Scalp
Intervention
Calcipotriol plus betamethasone dipropionate (LEO80185 gel)
Location
FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain
Quebec
Canada
G1V 4X7
Status
Completed
Source
LEO Pharma
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00216827
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Psoriasis
A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.
Betamethasone
A glucocorticoid given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Its lack of mineralocorticoid properties makes betamethasone particularly suitable for treating cerebral edema and congenital adrenal hyperplasia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p724)
Betamethasone 17-valerate
The 17-valerate derivative of BETAMETHASONE. It has substantial topical anti-inflammatory activity and relatively low systemic anti-inflammatory activity.
Tinea
A general term describing various dermatophytoses. Specific types include TINEA CAPITIS (ringworm of the scalp), TINEA FAVOSA (of scalp and skin), TINEA PEDIS (athlete's foot), and tinea unguium (see ONYCHOMYCOSIS, ringworm of the nails). (Dorland, 27th ed)
Piedra
Either of two diseases resulting from fungal infection of the hair shafts. Black piedra occurs mainly in and on the hairs of the scalp and is caused by Piedraia hortae; white piedra occurs in and on the hairs of the scalp, beard, moustache and genital areas and is caused by Trichosporon beigelii.
Clinical Trials
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Scalp Psoriasis
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 e...
The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment of...
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris
The objective of the study is to compare the use of calcipotriol plus betamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and...
This study will evaluate the efficacy and safety of calcipotriol plus betamethasone dipropionate ointment compared with calcipotriol ointment in the treatment of patients with psoriasis vu...
This single arm study will evaluate the efficacy and safety of sequential treatment with Diavobet (betamethasone propionate 0.5mg/g plus calcipotriol hydrate 50 micrograms/g) once daily fo...
PubMed Articles
Calcipotriol plus betamethasone dipropionate gel in the treatment of scalp psoriasis : A review.
Scalp psoriasis has a significant psychosocial impact on individuals affecting their quality of life. It occurs in 50-80% of patients with psoriasis and may be the only affected area of the body. Curr...
A calcipotriol/hydrocortisone combination ointment has been developed for treating psoriasis on sensitive skin areas such as the face. The efficacy and safety of two calcipotriol/hydrocortisone dose c...
The two-compound ointment (Taclonex/Daivobet/Dovobet ointment) combining calcipotriene 50 microg/g and betamethasone 0.5 mg/g (as dipropionate) is very effective in the treatment of psoriasis vulgaris...
We compared the clinical efficacy of various psoriasis treatments among: (i) topical application of calcipotriol ointment twice daily (group I); (ii) topical application of calcipotriol ointment twice...
Scalp psoriasis: an overview of the disease and available therapies.
The scalp is one of the regions of the body most commonly affected by psoriatic lesions. While the head represents only 10 percent of the body's surface area, the consequences of scalp psoriasis are d...
