Irritation
Conditions
Keywords
Healthy volunteers
Brief summary
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.
Interventions
DRUGSix different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues.
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical scoring of the skin reaction. | 10 days | Clinical evaluation of the irritation on 8-level scale (from score 0: no evidence of irritation, to score 7: strong reaction speading beyond the application site) |
Secondary
| Measure | Time frame |
|---|---|
| Transepidermal waterloss measurements | 10 days |
Countries
France
Outcome results
None listed