RecruitingPhase 4NCT06840470
Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia
Sponsor
University of Michigan
Enrollment
40 participants
Start Date
Mar 11, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This study is being completed to determine if 8 weeks of treatment with imiquimod can shrink sebaceous hyperplasia.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria10
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGImiquimod 5% Topical Cream
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06840470