Back to resultsCombined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
LEO 90100
Vehicle
Petrolatum ointment
Sponsored by
About this trial
This is an interventional other trial for Psoriasis Vulgaris
Eligibility Criteria
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)
Sites / Locations
- CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital de l'Archet 2
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Other
Arm Label
LEO 90100
Vehicle
Petrolatum ointment
Arm Description
Outcomes
Primary Outcome Measures
Mean Cumulative Irritation index and maximal dermal response during induction phase
Number of subjects with positive sensitisation reaction at each test site in the challenge phase
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01935869
Brief Title
Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100
Official Title
Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEO 90100
Arm Type
Experimental
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Title
Petrolatum ointment
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
LEO 90100
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Type
Drug
Intervention Name(s)
Petrolatum ointment
Primary Outcome Measure Information:
Title
Mean Cumulative Irritation index and maximal dermal response during induction phase
Time Frame
3 weeks
Title
Number of subjects with positive sensitisation reaction at each test site in the challenge phase
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Queille-Roussel, MD
Organizational Affiliation
CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital de l'Archet 2
City
Nice Cedex 3
ZIP/Postal Code
06202
Country
France
12. IPD Sharing Statement
Citations:
Citation
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).
Results Reference
result
Learn more about this trial
Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100
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