Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia

NCT06840470 | Recruiting Phase 4 FDA Drug

• 1 other identifier: HUM00262234
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sebaceous Hyperplasia

Keywords

Lesions on both sides of the face; Topical imiquimod

Outcome Measures

Primary Outcomes (1)

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

  16 weeks

Secondary Outcomes (3)

• 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

  Up to 8 weeks

Study Arms (2)

Imiquimod

EXPERIMENTAL

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

No treatment

NO INTERVENTION

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.

Interventions

Imiquimod 5% Topical Cream DRUG

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.

Also known as: Aldara

Imiquimod

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Interventions

Imiquimod

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sunny Wong, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Durgin, MD, MSc

CONTACT

734-936-4054; durginj@umich.edu

Mio Nakamura, MD

CONTACT

734-936-4054; mionak@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Model Details: Each subject's face will be divided randomly into an imiquimod-treated side and an untreated control side.

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): March 11, 2027
• Study Completion (Estimated): September 11, 2027
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)