Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-06

Study Completion Date

2017-03-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study has a randomized, evaluator-blinded, vehicle- controlled study to assess the pharmacodynamics of omiganan and omiganan with imiquimod in healthy volunteers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts

NCT02849262

Condylomata Acuminata (External)

COMPLETED PHASE2

A Double-blind, Randomized, Single Centre, Vehicle-controlled Study to Evaluate the Safety and Tolerability of a New Topical Formulation Containing 0,09% Imiquimod (Limtop) in Healthy Subjects

NCT01567683

Healthy

COMPLETED PHASE1

Study of Imiquimod Cream Prior to Ablative Therapy in External Ano-Genital Warts

NCT00189293

Genital Warts

COMPLETED PHASE4

A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LFX453

NCT02052687

Healthy

COMPLETED PHASE1

Safety and Efficacy of Imiquimod Applied in Dose-Cycle for Actinic Keratoses

NCT00175643

Actinic Keratoses

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Omiganan

Group Type EXPERIMENTAL

Omiganan

Intervention Type DRUG

Omignan 1%, 2.5%

Imiquimod

Group Type EXPERIMENTAL

Imiquimod

Intervention Type DRUG

Imiquimod 15mg

Omiganan 1% and Imiquimod

Group Type EXPERIMENTAL

Omiganan 1% and Imiquimod

Intervention Type DRUG

Omiganan 1% and Imiquimod

Omiganan 2.5% and Imiquimod

Group Type EXPERIMENTAL

Omiganan 2.5% and Imiquimod

Intervention Type DRUG

Omiganan 2.5% and Imiquimod

Placebo

Vehicle

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vehicle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Omiganan

Omignan 1%, 2.5%

Intervention Type DRUG

Imiquimod

Imiquimod 15mg

Intervention Type DRUG

Omiganan 1% and Imiquimod

Intervention Type DRUG

Omiganan 2.5% and Imiquimod

Intervention Type DRUG

Placebo

Vehicle

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male and female subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, blood serology and urinalysis.
* Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg.
* Fitzpatrick skin type I-III (Caucasian)
* Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.
* Able and willing to give written informed consent and to comply with the study restrictions.

Exclusion Criteria

* Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients
* Family history of psoriasis
* History of pathological scar formation (keloid, hypertrophic scar)
* Have any current and / or recurrent pathologically, clinical significant skin condition.
* Previous use of imiquimod/ resiquimod/ gardiquimod
* Known hypersensitivity to the (non)investigational drug, drugs of the same class, or any of their excipients.
* Hypersensitivity for dermatological marker at screening
* Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study.
* Use of topical medication (prescription or over-the-counter \[OTC\]) within 30 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area
* Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment.
* Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
* Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening
* Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes