An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects

Conditions
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Irritation

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcipotriol ointment<br> | Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical scoring of the skin reaction. | 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) | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transepidermal waterloss measurements |  | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers