Rosacea, ErythematotelangiectaticPhase 1TOMIRNCT05616923
Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea
A Phase 1 study testing Trametinib in people with Rosacea, Erythematotelangiectatic, run by Albany Research Institute, Inc. at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rosacea, Erythematotelangiectatic
- What is being tested?
- Trametinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 31 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Erythematotelangiectatic rosacea diagnosed by a clinician in the centrofacial and/or ocular regions.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Samuel S. Stratton VA Medical Center
Albany, New York, 12208
About this study
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
Read the 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.
- Conditions
- Rosacea, Erythematotelangiectatic
- Being tested
- Trametinib
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrametinibDrug
Also called MAPK inhibitor
Topical cream containing 0.1 mg/g trametinib
| Study group | Role | What they receive |
|---|---|---|
| Trametinib | Experimental | Cheek describing the active compound (topical cream containing 0.1 mg/g trametinib) Receives: Drug: Trametinib |
| Vehicle | Placebo comparator | Cheek receiving cream without active compound (topical cream lacking active ingredient) Receives: Drug: Trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 22 days
Secondary outcomes (1)
Systemic drug absorption
Blood levels of trametinib will be assessed by high-performance liquid chromatography
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Nov 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rosacea, ErythematotelangiectaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacqueline Busingye, MD, Principal investigator, Stratton VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616923
- Sponsor's protocol ID
- 137506
- Acronym
- TOMIR
- Status last verified
- May 2023
- First submitted
- 9 Nov 2022
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea
- ClinicalTrials.gov ID
- NCT05616923
- Acronym / sponsor ID
- TOMIR / 137506
- Conditions
- Rosacea, Erythematotelangiectatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Albany Research Institute, Inc.University, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Trametinib | Experimental | Drug: TrametinibCheek describing the active compound (topical cream containing 0.1 mg/g trametinib) |
| Vehicle | Placebo comparator | Drug: TrametinibCheek receiving cream without active compound (topical cream lacking active ingredient) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Erythematotelangiectatic rosacea diagnosed by a clinician in the centrofacial and/or ocular regions.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrametinibAlso: MAPK inhibitorTopical cream containing 0.1 mg/g trametinib | Drug | Trametinib, Vehicle |
Primary outcome
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.
1 secondary outcome
Systemic drug absorption
Time frame: 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Busingye, MD principal investigator
Stratton VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trametinib in people with Rosacea, Erythematotelangiectatic, run by Albany Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dermatologic score (time frame: 22 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.