Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia

University of Michigan

Status and phase: Enrolling; Phase 4

Conditions: Sebaceous Hyperplasia

Treatments: Drug: Imiquimod 5% Topical Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT06840470

HUM00262234

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Imiquimod

Experimental group

Description:

Will be applied 3 times weekly ((i.e. Monday, Wednesday, and Friday prior to bedtime) to one side of the face.

Treatment:

Drug: Imiquimod 5% Topical Cream

No treatment

No Intervention group

Description:

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.