An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects

Irritation Clinical Trial

Official title:

An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105234
• Other study ID #: MCO 0901 FR
• Secondary ID: 2009-017394-38
• Status: Completed
• Phase: Phase 1
• First received: February 25, 2010
• Last updated: March 25, 2015
• Start date: April 2010
• Est. completion date: May 2010

Study information

• Verified date: March 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Irritation

Intervention

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

Locations

Country	Name	City	State
France	LEO Pharma site	Nice

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Transepidermal waterloss measurements		10 days	Yes

External Links

•   Clinical Trials at LEO Pharma