Phase
Condition
Warts
Psoriasis And Psoriatic Disorders
Skin Wounds
Treatment
Dovobet® ointment
LEO 90100 foam
Clinical Study ID
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Signed and dated informed consent obtained
Japanese subjects
Aged 20 years or above
Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less thanor equal to 30% BSA (excluding psoriasis on the face/genitals/skin folds).
A target psoriasis lesion of at least mild severity on the body of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of the clinical signs). The lesionmust not be on the scalp, face, genitals or skin folds.
Women of childbearing potential must have a negative pregnancy test at Day 1 andagree to use an adequate methods of birth control during the trial.
Able to communicate with the (sub)investigator and understand and comply with therequirements of the trial.
Exclusion
Key Exclusion Criteria:
Systemic use of biological treatments with a potential effect on psoriasis vulgariswithin the specified time periods prior to randomisation (depending on treatment)
Systemic treatments with all therapies other than biological treatments with apotential effect on psoriasis vulgaris within 4 weeks prior to randomisation
PUVA therapy, UVB therapy or UVA therapy on the full body or on the target lesionwithin 4 weeks prior to randomisation
Topical treatment of psoriasis on the areas to be treated with trial medicationwithin 2 weeks prior to randomisation
Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D3analogues, potent corticosteroids or immunosuppressants within 2 weeks prior torandomisation
Topical treatment of conditions other than psoriasis with vitamin D3 analogues,potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation
Initiation or changes of medication that may affect psoriasis vulgaris during thetrial
Patients with certain disorders or symptoms present on the areas to be treated withtrial medication: viral lesions of the skin, infections, skin manifestations, orfragility of skin veins
Other inflammatory skin diseases that may confound the evaluation of psoriasisvulgaris
Erythrodermic, exfoliative or pustular psoriasis on the areas to be treated withtrial medication
Planned excessive exposure of areas to be treated with trial medication to eithernatural or artificial sunlight during the trial.
Disorders of calcium metabolism
Severe renal insufficiency, severe hepatic disorders or severe heart disease
Hypersensitivity to any components of the investigational medicinal products.
Cushing's disease or Addison's disease
Subjects who have received treatment with any non-marketed drug substance within the 4 weeks prior to randomisation, or longer if for certain biological treatments
History of cancer within the last 5 years (except completely cured skin cancer)
Current participation in any other interventional clinical trial
Previously randomised in this trial
Women who are pregnant, wishing to become pregnant or are breast-feeding
Chronic alcohol or drug abuse within 12 months prior to screening, or any conditionassociated with poor compliance
Employees of the trial site or any other individuals directly involved with theplanning or conduct of the trial, or immediate family members of such individuals
Study Design
Study Description
Connect with a study center
Leo Pharma Investigational Site
Fukutsu, Fukuoka 811-3217
JapanSite Not Available
Leo Pharma Investigational Site
Obihiro, Hokkaido 080-0013
JapanSite Not Available
Leo Pharma Investigational Site
Sapporo, Hokkaido 006-0814
JapanSite Not Available
Leo Pharma Investigational Site
Nonoichi, Ishikawa 921-8801
JapanSite Not Available
Leo Pharma Investigational Site
Kawasaki, Kanagawa 213-0001
JapanSite Not Available
Leo Pharma Investigational Site
Yokohama, Kanagawa 220-6208
JapanSite Not Available
Leo Pharma Investigational Site
Sendai, Miyagi 981-3133
JapanSite Not Available
Leo Pharma Investigational Site
Saitama-shi, Saitama 330-0854
JapanSite Not Available
Leo Pharma Investigational Site
Chiyoda-ku, Tokyo 101-0021
JapanSite Not Available
Leo Pharma Investigational Site
Itabashi-ku, Tokyo 173-8605
JapanSite Not Available
Leo Pharma Investigational Site
Kita-ku, Tokyo 115-0045
JapanSite Not Available
Leo Pharma Investigational Site
Koto-Ku, Tokyo 136-0074
JapanSite Not Available
Leo Pharma Investigational Site
Minato-Ku, Tokyo 108-0014
JapanSite Not Available
Leo Pharma Investigational Site
Setagaya, Tokyo 158-0094
JapanSite Not Available
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