Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia

This study is being completed to determine if 8 weeks of treatment with imiquimod can shrink sebaceous hyperplasia.

Study Overview

• Status: Active, not recruiting
• Conditions: Sebaceous Hyperplasia
• Intervention / Treatment: Drug: Imiquimod 5% Topical Cream

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient has sebaceous hyperplasia lesions on both sides of the face. At least one sebaceous hyperplasia lesion on each side of the face is 1 mm or more in size.
• If of child-bearing potential, subject agrees to the use of highly effective contraception during study participation. For women of childbearing potential, acceptable pregnancy prevention measures will include abstinence, barrier methods, chemical methods, or surgical.
• Ability to understand and willingness to sign a written informed consent

Exclusion Criteria:

• Current use or prior use of a retinoid (e.g. tretinoin) within the last 4 weeks.
• Prior use of imiquimod on the treated area.
• Concurrent use of 5-fluorouracil, aminolevulinic acid (photodynamic therapy), or psoralen therapy, or use of any of these within the last 4 weeks.
• Concurrent facial peels or cosmetic laser therapy on the treated areas.
• Nursing, pregnant or planning to become pregnant.
• Immunocompromised status (e.g. organ transplantation recipients or patients on cyclosporine).
• Current participation in other investigational trials.
• Known or suspected history of a clinically significant systemic disease (e.g., immunological deficiencies), unstable medical disorders (e.g., unstable diabetes), life-threatening disease or current malignancies.
• Known hypersensitivity to any of the following (in any dosage form): imiquimod or any component of the study medications.
• Received radiation therapy and/or anti-neoplastic agents within 3 months prior to study entry.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imiquimod; Will be applied 3 times weekly ((i.e. Monday, Wednesday, and Friday prior to bedtime) to one side of the face.	Drug: Imiquimod 5% Topical Cream; Participants will apply this cream to one side of the face 3 times a week for up to 8 weeks. The cream will be applied before bedtime. The imiquimod should be washed off with mild soap and water after 6-10 hours. Participants will have baseline and follow-up visits that will include photographs of the lesions.; Other Names: Aldara
No Intervention: No treatment; Lesions on the other side of the face will not be treated. Participants will have baseline and follow-up visits that will include photographs of the lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete and 75% clearance rates (clearance refers to reduction in total lesional area) at 16 weeks of treated lesions	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in Sebaceous Hyperplasia (SH) count		16 weeks
Mean change in Sebaceous Hyperplasia (SH) diameter		16 weeks
Adverse events (AE) associated with imiquimod 5% cream when used in the treatment of sebaceous hyperplasia	The following will be described for Adverse events per protocol: Serious or non-serious; Mild, moderate, Severe; The relationship (unexpected or expected) of the study drug; Attribution of the AE: Definite, Probably, Possible, Unlikely, Unrelated.	Up to 8 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Sunny Wong, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2025
• Primary Completion (Estimated): May 6, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): February 21, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Lesions on both sides of the face; Topical imiquimod
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperplasia; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinolines; Aminoquinolines; Imiquimod
• Other Study ID Numbers: HUM00262234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No