Back to resultsTopical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea (TOMIR)
Primary Purpose
Rosacea, Erythematotelangiectatic
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Trametinib
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea, Erythematotelangiectatic
Eligibility Criteria
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)
Sites / Locations
- Samuel S. Stratton VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Trametinib
Vehicle
Arm Description
Cheek describing the active compound (topical cream containing 0.1 mg/g trametinib)
Cheek receiving cream without active compound (topical cream lacking active ingredient)
Outcomes
Primary Outcome Measures
Change in dermatologic score
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.
Secondary Outcome Measures
Systemic drug absorption
Blood levels of trametinib will be assessed by high-performance liquid chromatography
Full Information
NCT ID
NCT05616923
First Posted
November 9, 2022
Last Updated
May 26, 2023
Sponsor
Albany Research Institute, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05616923
Brief Title
Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea
Acronym
TOMIR
Official Title
Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albany Research Institute, Inc.
4. Oversight
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
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea, Erythematotelangiectatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trametinib
Arm Type
Experimental
Arm Description
Cheek describing the active compound (topical cream containing 0.1 mg/g trametinib)
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Cheek receiving cream without active compound (topical cream lacking active ingredient)
Intervention Type
Drug
Intervention Name(s)
Trametinib
Other Intervention Name(s)
MAPK inhibitor
Intervention Description
Topical cream containing 0.1 mg/g trametinib
Primary Outcome Measure Information:
Title
Change in dermatologic score
Description
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.
Time Frame
22 days
Secondary Outcome Measure Information:
Title
Systemic drug absorption
Description
Blood levels of trametinib will be assessed by high-performance liquid chromatography
Time Frame
22 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Busingye, MD
Organizational Affiliation
Stratton VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samuel S. Stratton VA Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea
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