An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01105234
First received: February 25, 2010
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Irritation
Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues.
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Official Title: An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Clinical scoring of the skin reaction. [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    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:
  • Transepidermal waterloss measurements [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: April 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcipotriol ointment Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105234

Locations
France
LEO Pharma site
Nice, France, 06202
Sponsors and Collaborators
LEO Pharma
Investigators
Study Director: Patrice Facy, PhD LEO Pharma
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01105234     History of Changes
Other Study ID Numbers: MCO 0901 FR, 2009-017394-38
Study First Received: February 25, 2010
Last Updated: October 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by LEO Pharma:
Healthy volunteers

Additional relevant MeSH terms:
Vitamin D
Vitamins
Calcitriol
Calcipotriene
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Dermatologic Agents
Therapeutic Uses
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 25, 2014