Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia

August 7, 2026 updated by: Sunny Wong, University of Michigan
This study is being completed to determine if 8 weeks of treatment with imiquimod can shrink sebaceous hyperplasia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in Sebaceous Hyperplasia (SH) count
Time Frame: 16 weeks
16 weeks
Mean change in Sebaceous Hyperplasia (SH) diameter
Time Frame: 16 weeks
16 weeks
Adverse events (AE) associated with imiquimod 5% cream when used in the treatment of sebaceous hyperplasia
Time Frame: Up to 8 weeks

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

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2025

Primary Completion (Actual)

April 8, 2026

Study Completion (Actual)

April 8, 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)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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