Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia

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.

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.