Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea

NCT05616923 | Completed Phase 1 FDA Drug

• 1 other identifier: 137506
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Rosacea, Erythematotelangiectatic

Outcome Measures

Primary Outcomes (1)

• 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.

  22 days

Secondary Outcomes (1)

• Systemic drug absorption

  22 days

Study Arms (2)

Trametinib

EXPERIMENTAL

Cheek describing the active compound (topical cream containing 0.1 mg/g trametinib)

Drug: Trametinib

Vehicle

PLACEBO COMPARATOR

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

Drug: Trametinib

Interventions

Trametinib DRUG

Topical cream containing 0.1 mg/g trametinib

Also known as: MAPK inhibitor

Trametinib; Vehicle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Erythematotelangiectatic rosacea diagnosed by a clinician in the centrofacial and/or ocular regions.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Albany Research Institute, Inc.: lead

Study Sites (1)

Samuel S. Stratton VA Medical Center

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

trametinib; p38 MAPK inhibitor SB203582

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jacqueline Busingye, MD

  Stratton VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 15, 2022
• Study Start: November 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)