Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia

Last updated: March 31, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

4

Condition

Non-inflammatory Comedones

Treatment

Imiquimod 5% Topical Cream

Clinical Study ID

NCT06840470
HUM00262234
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient has sebaceous hyperplasia lesions on both sides of the face. At least onesebaceous 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 effectivecontraception 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

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), orpsoralen 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 oncyclosporine).

  • 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 orany component of the study medications.

  • Received radiation therapy and/or anti-neoplastic agents within 3 months prior tostudy entry.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Imiquimod 5% Topical Cream
Phase: 4
Study Start date:
March 11, 2025
Estimated Completion Date:
September 11, 2027

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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