Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea (TOMIR)

May 26, 2023 updated by: Albany Research Institute, Inc.
This is a prospective, vehicle controlled, double blinded study to evaluate the safety and potential efficacy of a topical formulation of a MEK inhibitor in patients with erythematotelangiectatic rosacea

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The duration of the study will be 22 days. Subjects will use a cream with a mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor on one cheek, and a cream lacking the inhibitor (vehicle control) on the other. Patients will receive a randomized set of creams for the right and left cheek, one containing the active ingredient. Subjects will be evaluated on days 1, 8, 15 and 22. Skin appearance will be scored in each visit. A blood sample will be obtained to determine the levels of systemic drug absorption.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Samuel S. Stratton VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Erythematotelangiectatic rosacea diagnosed by a clinician in the centrofacial and/or ocular regions.

Exclusion Criteria:

  • Other concurrent diseases for which treatment is being received that would preclude the use of trametinib (i.e., pleural effusion, active infection, intracranial bleeding)
  • History of skin allergic reactions or documented allergic reaction to trametinib
  • Pregnancy or lactation.
  • Heart failure or other heart disease
  • Active use of medications with known documented interactions with trametinib (Chloroquine, Ritonavir, Loperamide, Penicillamine)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trametinib
Cheek describing the active compound (topical cream containing 0.1 mg/g trametinib)
Drug: Trametinib
Topical cream containing 0.1 mg/g trametinib
Other Names:
  • MAPK inhibitor
Placebo Comparator: Vehicle
Cheek receiving cream without active compound (topical cream lacking active ingredient)
Drug: Trametinib
Topical cream containing 0.1 mg/g trametinib
Other Names:
  • MAPK inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in dermatologic score
Time Frame: 22 days
Weekly assessment of skin irritation, using the Organization for Economic Cooperation and Development test for dermal irritation and corrosion. This test measures cutaneous erythema and edema separately on scales that range from 0 (absence of erythema or edema) to 4 (severe), with higher scores representing worse outcomes.
22 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic drug absorption
Time Frame: 22 days
Blood levels of trametinib will be assessed by high-performance liquid chromatography
22 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albany Research Institute, Inc.

Investigators

  • Principal Investigator: Jacqueline Busingye, MD, Stratton VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 137506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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