TOMIR: Topical MAPK Inhibition in Rosacea

Sponsor

Albany Research Institute, Inc. (Other)

Overall Status

Recruiting

CT.gov ID

NCT05616923

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rosacea, Erythematotelangiectatic	Drug: Trametinib	Phase 1

Detailed Description

The duration of the study will be 22 days. Subjects will use a cream with a 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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Each patient will receive two creams labeled "right cheek" or "left cheek", one containing the active ingredient and the other serving as vehicle control. The labels of each bottle were randomized and the contents of each remains blinded to both the subject and the investigator.Each patient will receive two creams labeled "right cheek" or "left cheek", one containing the active ingredient and the other serving as vehicle control. The labels of each bottle were randomized and the contents of each remains blinded to both the subject and the investigator.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Allocation of drug to cheek side for each bottle set is known only to an investigator not involved in patient assessment and will be unmasked only at the end of the trial.

Primary Purpose:

Treatment

Official Title:

Topical MAPK Inhibition in Rosacea

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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
Placebo Comparator: Vehicle Cheek receiving cream without active compound (topical cream lacking active ingredient)	Drug: Trametinib Topical cream containing 0.1 mg/g trametinib

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

Placebo Comparator: Vehicle

Cheek receiving cream without active compound (topical cream lacking active ingredient)

Drug: Trametinib

Topical cream containing 0.1 mg/g trametinib

Outcome Measures

Primary Outcome Measures

Change in dermatologic score [22 days]
Weekly assessment of skin irritation

Secondary Outcome Measures

Systemic drug absorption [22 days]
Blood levels of trametinib will be assessed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samuel S. Stratton VA Medical Center	Albany	New York	United States	12208

Sponsors and Collaborators

Albany Research Institute, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Albany Research Institute, Inc.

ClinicalTrials.gov Identifier:

NCT05616923

Other Study ID Numbers:

137506

First Posted:

Nov 15, 2022

Last Update Posted:

Nov 15, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Rosacea

Trametinib

Study Results

No Results Posted as of Nov 15, 2022