An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects

Phase 1

Completed

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

• Registration Number: NCT01105234
• Lead Sponsor: LEO Pharma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-25
• Study Start: 2010-04
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-16
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2015-03
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Calcipotriol ointment	Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues.	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Transepidermal waterloss measurements	10 days

Trial Locations

Locations (1)

LEO Pharma site; 🇫🇷 Nice, France