NCT02650505

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 24, 2025

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

December 4, 2015

Last Update Submit

February 21, 2025

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Study Arms (2)

LEO 43204

EXPERIMENTAL

LEO 43204 will be applied topically to the skin under open conditions 10 times

Drug: LEO 43204

LEO 43204 vehicle

PLACEBO COMPARATOR

LEO 43204 vehicle will be applied topically to the skin under open conditions 10 times

Drug: LEO 43204 Vehicle

Interventions

LEO 43204DRUG
LEO 43204
LEO 43204 VehicleDRUG
LEO 43204 vehicle

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TKL Research Inc.

Fair Lawn, New Jersey, 07410, United States

Location

Related Links

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

LEO 43204

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2015

First Posted

January 8, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 24, 2025

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)