Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100

Psoriasis Vulgaris Clinical Trial

Official title:

Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935869
• Other study ID #: LP0053-66
• Status: Completed
• Phase: Phase 1
• Start date: August 2013
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the skin irritation potential and sensitisation potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 1. Following verbal and written information about the trial, subject must provide signed and dated informed consent before any study related activities are carried out.

• 2. Healthy male or female subjects, 18 to 65 years of age inclusive at screening.

Exclusion Criteria:

• 1. Female subjects who are pregnant, of childbearing potential and who wish to become pregnant during the study, or who are breast feeding

• 2. Subjects with any systemic or cutaneous disorder that might interfere with the evaluation of the test site reactions (e.g. atopic dermatitis, contact eczema, psoriasis) 3. Subjects with scars, moles or other abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type V and VI on the Fitzpatrick scale)

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• LEO 90100

• Vehicle

• Petrolatum ointment

Locations

Country	Name	City	State
France	CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital de l'Archet 2	Nice Cedex 3

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

References & Publications (1)

Queille-Roussel C, Liljedahl M, Clonier F, Lacour JP. Phase I evaluation of the dermal safety of the fixed combination calcipotriene plus betamethasone dipropionate aerosol foam and foam vehicle. J Am Acad Dermatol. 2015:72 Suppl 1;AB211 (P844).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Cumulative Irritation index and maximal dermal response during induction phase		3 weeks
Primary	Number of subjects with positive sensitisation reaction at each test site in the challenge phase		6 weeks

External Links

•   Clinical Trials at LEO Pharma