Effect of Imiquimod on Facial Sebaceous Hyperplasia
Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia
This study is testing a cream called imiquimod to see if it can help reduce facial bumps caused by sebaceous hyperplasia in people who have them.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06840470 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a topical cream containing imiquimod in reducing sebaceous hyperplasia lesions on both sides of the face over an 8-week treatment period. Participants must have at least one lesion on each side that is 1 mm or larger. The study aims to assess the safety and efficacy of this treatment approach for individuals suffering from this skin condition.
Who should consider this trial
Good fit: Ideal candidates are individuals with sebaceous hyperplasia lesions on both sides of the face, with lesions measuring 1 mm or more.
Not a fit: Patients who have used retinoids or imiquimod on the treated area recently, or those who are pregnant or immunocompromised, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for patients seeking to reduce the appearance of sebaceous hyperplasia lesions.
How similar studies have performed: While there is limited data on the specific use of imiquimod for sebaceous hyperplasia, similar topical treatments have shown promise in managing other skin lesions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Sunny Wong, PhD — University of Michigan
- Study coordinator: Joseph Durgin, MD, MSc
- Email: durginj@umich.edu
- Phone: 734-936-4054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.