Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia

Phase 4

Recruiting

• Conditions: Sebaceous Hyperplasia
• Interventions: Drug: Imiquimod 5% Topical Cream

• Registration Number: NCT06840470
• Lead Sponsor: University of Michigan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Status Verified: 2025-03
• Study Start: 2025-03-11
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Primary Completion: 2027-03-11
• Study Completion: 2027-09-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imiquimod	Imiquimod 5% Topical Cream	Will be applied 3 times weekly ((i.e. Monday, Wednesday, and Friday prior to bedtime) to one side of the face.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States