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A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel

NCT02650505 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2025-02-24

No results posted yet for this study

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.

Conditions

  • Actinic Keratosis

Interventions

DRUG

LEO 43204

DRUG

LEO 43204 Vehicle

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02650505 on ClinicalTrials.gov