Back to resultsA Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LEO 43204
LEO 43204 Vehicle
Sponsored by
About this trial
This is an interventional other trial for Actinic Keratosis
Eligibility Criteria
Inclusion Criteria:
- Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
- Fitzpatrick skin types I-IV (due to lack of safety data for the investigational product in darker skin types);
- Complete a Medical Screening form as well as a Medical Personal History form;
Exclusion Criteria:
- Have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction;
- Are not willing to refrain from using topical/systemic analgesics for 72 hours prior to and during the study (daily use of 81 mg aspirin is acceptable and occasional use of acetaminophen will be permitted);
- Are using systemic/topical corticosteroids for 3 weeks prior to and during the study, or systemic/topical antihistamines for 72 hours prior to and during the study;
- Are using medication which, in the opinion of the investigative personnel, will interfere with the study results, including anti-inflammatory medications;
- Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions, or similar products on the back during the study;
- Have psoriasis and/or active atopic dermatitis/eczema;
- Have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
Sites / Locations
- TKL Research Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LEO 43204
LEO 43204 vehicle
Arm Description
LEO 43204 will be applied topically to the skin under open conditions 10 times
LEO 43204 vehicle will be applied topically to the skin under open conditions 10 times
Outcomes
Primary Outcome Measures
The determination of dermal sensitization will be based on LSRs and confirmed at a Rechallenge. If recurrence in Rechallenge is equivalent to or more severe than observed at challenge it will be considered indicative of a sensitization reaction.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02650505
Brief Title
A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel
Official Title
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of LEO 43204 Gel and Gel Vehicle in Healthy Volunteers Using a Repeat Insult Patch Test Design
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (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
This is a randomized, single-center, controlled, within-subject comparison study assessing the sensitization potential of the investigational product, LEO 43204 gel under open conditions in healthy volunteers.
LEO 43204 Gel and Vehicle Gel will be applied to adjacent sites on the infrascapular area of the back. Evaluation of dermal reactions at the application sites will be assessed clinically using a visual scale that rates the degree of erythema, edema and other signs of cutaneous irritation.
Following induction, subjects will have a 10 to 14-day Rest Phase, after which they will enter the Challenge Phase, which consists of one 48-hour application to a naive site on the opposite side of the back. Observations at the naive site during Challenge and the patterns of reactivity during the Induction Phase will provide a basis for an interpretation of contact sensitization.
A total of 10 applications will be made over a period of approximately 6-8 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
233 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEO 43204
Arm Type
Experimental
Arm Description
LEO 43204 will be applied topically to the skin under open conditions 10 times
Arm Title
LEO 43204 vehicle
Arm Type
Placebo Comparator
Arm Description
LEO 43204 vehicle will be applied topically to the skin under open conditions 10 times
Intervention Type
Drug
Intervention Name(s)
LEO 43204
Intervention Type
Drug
Intervention Name(s)
LEO 43204 Vehicle
Primary Outcome Measure Information:
Title
The determination of dermal sensitization will be based on LSRs and confirmed at a Rechallenge. If recurrence in Rechallenge is equivalent to or more severe than observed at challenge it will be considered indicative of a sensitization reaction.
Time Frame
8 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:
Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
Fitzpatrick skin types I-IV (due to lack of safety data for the investigational product in darker skin types);
Complete a Medical Screening form as well as a Medical Personal History form;
Exclusion Criteria:
Have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction;
Are not willing to refrain from using topical/systemic analgesics for 72 hours prior to and during the study (daily use of 81 mg aspirin is acceptable and occasional use of acetaminophen will be permitted);
Are using systemic/topical corticosteroids for 3 weeks prior to and during the study, or systemic/topical antihistamines for 72 hours prior to and during the study;
Are using medication which, in the opinion of the investigative personnel, will interfere with the study results, including anti-inflammatory medications;
Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions, or similar products on the back during the study;
Have psoriasis and/or active atopic dermatitis/eczema;
Have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
Facility Information:
Facility Name
TKL Research Inc.
City
Fair Lawn
State/Province
New Jersey
ZIP/Postal Code
07410
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel
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