An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects

NCT01105234 | Completed Phase 1

• 2 other identifiers: MCO 0901 FR2009-017394-38
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritation

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Transepidermal waterloss measurements

  10 days

Study Arms (1)

Calcipotriol ointment

EXPERIMENTAL

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

Interventions

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

Calcipotriol ointment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

LEO Pharma site

Nice, 06202, France

Location

Related Links

• Clinical Trials at LEO Pharma

Study Officials

• Patrice Facy, PhD

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: April 16, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 24, 2025

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)