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MEK Inhibitor

Trametinib for Rosacea (TOMIR Trial)

Phase 1
Waitlist Available
Led By Jacqueline Busingye, MD
Research Sponsored by Albany Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Erythematotelangiectatic rosacea diagnosed by a clinician in the centrofacial and/or ocular regions.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22 days
Awards & highlights

TOMIR Trial 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

Eligible Conditions
  • Rosacea

TOMIR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

TOMIR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 22 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in dermatologic score
Secondary outcome measures
Systemic drug absorption

Side effects data

From 2021 Phase 2 trial • 206 Patients • NCT02034110
58%
Pyrexia
42%
Nausea
35%
Vomiting
33%
Diarrhoea
33%
Fatigue
28%
Gamma-glutamyltransferase increased
28%
Chills
28%
Rash
26%
Aspartate aminotransferase increased
23%
White blood cell count decreased
23%
Cough
23%
Anaemia
23%
Decreased appetite
23%
Headache
21%
Constipation
21%
Blood alkaline phosphatase increased
19%
Dry mouth
19%
Hyperglycaemia
19%
Myalgia
16%
Alanine aminotransferase increased
16%
Asthenia
16%
Abdominal pain upper
16%
Thrombocytopenia
16%
Dyspnoea
14%
Hypertension
14%
Arthralgia
14%
Insomnia
12%
Platelet count decreased
12%
Eczema
12%
Blood creatinine increased
12%
Pruritus
12%
Abdominal pain
12%
Hypomagnesaemia
12%
Hyponatraemia
12%
Erythema
9%
Oedema peripheral
9%
Hypokalaemia
9%
Dermatitis acneiform
9%
Rash maculo-papular
9%
Neutrophil count decreased
9%
Weight increased
9%
Back pain
9%
Dry skin
7%
Blood bilirubin increased
7%
Sepsis
7%
Neutropenia
7%
Mucosal inflammation
7%
Oedema
7%
Cholangitis
7%
Hypoalbuminaemia
7%
Stomatitis
7%
Dyspepsia
7%
Influenza like illness
7%
Herpes zoster
7%
Glycosylated haemoglobin increased
7%
Weight decreased
7%
Musculoskeletal pain
7%
Pain in extremity
7%
Anxiety
7%
Acute kidney injury
7%
Night sweats
5%
Hypophosphataemia
5%
Skin lesion
5%
Erythema nodosum
5%
Dry eye
5%
Toothache
5%
Muscle spasms
5%
Blood creatine phosphokinase increased
5%
Hyperuricaemia
5%
Gastrooesophageal reflux disease
5%
Leukopenia
5%
Folliculitis
5%
Urinary tract infection
5%
Fall
5%
Lymphocyte count decreased
5%
Hypoglycaemia
5%
Joint swelling
5%
Neuropathy peripheral
5%
Epistaxis
5%
Oropharyngeal pain
5%
Acne
5%
Hyperkeratosis
2%
Hot flush
2%
Femoral neck fracture
2%
Hypersensitivity
2%
Upper respiratory tract infection
2%
Productive cough
2%
Pain in jaw
2%
Epilepsy
2%
Peripheral sensory neuropathy
2%
Depression
2%
Hypercalcaemia
2%
Dizziness
2%
Skin mass
2%
Pneumonia
2%
Thrombophlebitis
2%
Tachycardia
2%
Musculoskeletal chest pain
2%
Dysgeusia
2%
Sciatica
2%
Gastroenteritis
2%
Febrile neutropenia
2%
Atrial fibrillation
2%
Oral pain
2%
Rectal haemorrhage
2%
Paronychia
2%
Device related infection
2%
Rhinitis
2%
Sinusitis
2%
Respiratory tract infection
2%
Hyperkalaemia
2%
Transaminases increased
2%
Dehydration
2%
Spinal pain
2%
Haemorrhoids
2%
Cataract
2%
Eye pain
2%
Vision blurred
2%
Visual impairment
2%
Abdominal discomfort
2%
Abdominal distension
2%
Gait disturbance
2%
Non-cardiac chest pain
2%
Xerosis
2%
Conjunctivitis
2%
Nasopharyngitis
2%
Rash pustular
2%
Tooth abscess
2%
Tooth infection
2%
Procedural pain
2%
Blood lactate dehydrogenase increased
2%
Blood uric acid increased
2%
C-reactive protein increased
2%
Muscular weakness
2%
Neck pain
2%
Basal cell carcinoma
2%
Seborrhoeic keratosis
2%
Paraesthesia
2%
Proteinuria
2%
Renal failure
2%
Nasal congestion
2%
Pleural effusion
2%
Nail discolouration
2%
Palmar-plantar erythrodysaesthesia syndrome
2%
Photosensitivity reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Biliary Tract Cancer (BTC) (On-Treatment)
Hairy Cell Leukemia (HCL) (On-Treatment)
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Multiple Myeloma (MM) (On-Treatment)
Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
Adenocarcinoma of the Small Intestine (ASI) (On-Treatment)
Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up)
Multiple Myeloma (MM) (Post-treatment Survival Follow-up)

TOMIR Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TrametinibExperimental Treatment1 Intervention
Cheek describing the active compound (topical cream containing 0.1 mg/g trametinib)
Group II: VehiclePlacebo Group1 Intervention
Cheek receiving cream without active compound (topical cream lacking active ingredient)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
2014
Completed Phase 2
~1550

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Albany Research Institute, Inc.Lead Sponsor
2 Previous Clinical Trials
85 Total Patients Enrolled
Jacqueline Busingye, MDPrincipal InvestigatorStratton VA Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any way I can participate in this medical study?

"Eligibility requirements are that patients have been diagnosed with rosacea, erythematotelangiectatic and aged between 18 to 75. This clinical trial intends to accept roughly 20 participants."

Answered by AI

How many individuals are currently participating in the experiment?

"Affirmative. According to the information found on clinicaltrials.gov, this medical experiment is currently looking for candidates who meet its criteria. This study was first published on November 1st 2021 and last updated on the 9th of November 2022; it seeks 20 participants at a single site."

Answered by AI

Are elderly participants currently able to join this trial?

"This trial has specified that applicants must be between 18 and 75 to qualify. Younger participants are eligible for 1 study, while individuals over 65 can apply to 12 additional studies."

Answered by AI

What perils are associated with the utilization of Trametinib?

"Trametinib's safety is rated a 1, given that only limited clinical data exists to confirm efficacy and safety."

Answered by AI

Is enrollment in this research project still an option?

"Clinicaltrials.gov reveals that this trial, which began recruiting on the 1st of November 2021, is still searching for participants. The latest update was posted on 9th of November 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea
2021. "Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05616923.
~4 spots leftby Apr 2025
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