Rosacea, Erythematotelangiectatic
Conditions
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.
Interventions
DRUGTrametinib
Topical cream containing 0.1 mg/g trametinib
Sponsors
Albany Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in dermatologic score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic drug absorption | 22 days | Blood levels of trametinib will be assessed by high-performance liquid chromatography |
Countries
United States
Outcome results
None listed