An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects

LEO Pharma

Status and phase

Completed

Phase 1

Conditions

Irritation

Treatments

Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues.

Study type

Interventional

Funder types

Industry

Identifiers

NCT01105234

MCO 0901 FR

2009-017394-38 (EudraCT Number)

Details and patient eligibility

About

The purpose of this trial is to compare the skin irritation potential of eight different formulations of vitamin D analogues after repeated applications on intact skin of healthy subjects.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects having understood and signed an informed consent form.
Either sex
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.

Exclusion criteria

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