Trial intelligence / Profile preview

Topical Imiquimod for Sebaceous Hyperplasia

NCT06840470Phase 4

Key facts

Status: Completed
Start: Mar 2025
Primary completion: Apr 2026
Countries: 1
Sponsor: University of Michigan
Modality: Nucleic Acid-Directed Small Molecules, Irreversible Covalent Inhibitors, Metabolically Activated Prodrugs

Drugs: imiquimod
Conditions: Sebaceous hyperplasia (SGH)

Overview

Phase 4, open-label trial of imiquimod in Sebaceous hyperplasia (SGH) (2 arms), sponsored by University of Michigan. Primary endpoint: Complete and 75% clearance rates at 16 weeks. Started Mar 2025; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

Imiquimod
Imiquimod 5% Topical Cream applied 3 times weekly to one side of the face.
No treatment
Lesions on the other side of the face will not be treated.

Who it enrols

Patients with sebaceous hyperplasia lesions >= 1mm on both sides of the face, excluding those who are pregnant, immunocompromised, or have recently used specific topical treatments or procedures on the face.

Endpoints

Primary

Complete and 75% clearance rates16 weeks

Secondary

Mean change in Sebaceous Hyperplasia (SH) count16 weeks
Mean change in Sebaceous Hyperplasia (SH) diameter16 weeks
Adverse events (AE) associated with imiquimod 5% cream8 weeks

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