An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects having understood and signed an informed consent form.
Healthy subjects, 18 to 65 years of age
Subjects with skin types I to IV according to Fitzpatrick Scale
Subjects without erythema on test areas on the mid back skin (visual irritation score = 0) at baseline (Day 1), before randomisation.
Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding
Any topical or systemic corticosteroids or immuno-suppressors within 3 weeks prior to randomisation
Any other medication which may interfere with the study results, in particular topical drugs applied on the test area within 2 weeks prior to randomisation
Any other products which may interfere with the study results, in particular emollients, creams, gels, lotions and body powders applied on the test area within 24 hours prior to randomisation
Any systemic or cutaneous disease that may confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis)
Scars, moles, sunburn, or other blemishes in the test area which may interfere with grading
Exposure to excessive or chronic UV radiation (i.e., sunbathing, solarium, phototherapy) within 2 weeks prior to randomisation or is planned during the study period
Known or suspected hypersensitivity to any component of the investigational products
Participation in any other interventional clinical trial within 4 weeks prior to randomisation or during the study period, based on interview of the subject
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action