Imiquimod for Sebaceous Hyperplasia

Overseen By Mio Nakamura, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Michigan

Must not be taking: Retinoids, 5-fluorouracil, Psoralen

Disqualifiers: Pregnancy, Immunocompromised, Unstable diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether imiquimod, a topical cream, can shrink sebaceous hyperplasia, the small, benign bumps often found on the face. Participants will apply the cream to one side of their face three times a week, leaving the other side untreated for comparison. This study suits individuals with sebaceous hyperplasia bumps on both sides of their face, with at least one bump measuring 1 mm or more. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications like retinoids, 5-fluorouracil, aminolevulinic acid, or psoralen therapy at least 4 weeks before starting. If you're using these, you'll need to stop them before joining the study.

What is the safety track record for this treatment?

Studies have shown that imiquimod is generally safe for people. The FDA has already approved it for treating other skin conditions like actinic keratosis and basal cell carcinoma, indicating a good safety record.

Most users of imiquimod may experience some redness or skin irritation at the application site. These are the most common side effects, but they are usually mild and resolve after stopping the treatment.

As this trial is in a later phase, extensive safety information about imiquimod is available. This should help potential participants feel more confident about its safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Imiquimod is unique because it taps into the body's own immune system to target sebaceous hyperplasia. Unlike standard treatments like cryotherapy, laser therapy, or surgical removal, which physically remove the lesions, Imiquimod works by stimulating the immune system to reduce the lesions naturally. Researchers are excited about Imiquimod because it offers a non-invasive option that can be applied topically, potentially leading to fewer side effects and a more convenient treatment process for patients.

What is the effectiveness track record for imiquimod in treating sebaceous hyperplasia?

Research has shown that imiquimod effectively treats sebaceous hyperplasia, a condition where small bumps form on the skin due to enlarged oil glands. In earlier studies, applying imiquimod cream three times a week completely cleared the bumps in 26.8% of cases after the first round of treatment. After a second, shorter round, the clearance rate increased to 53.7%. This trial will test the application of imiquimod cream three times weekly on one side of the face, while the other side receives no treatment. Imiquimod can significantly reduce or even eliminate these skin bumps for many people, working especially well on small and shallow bumps. ^{1 3 4 5 6}

Who Is on the Research Team?

Sunny Wong, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This clinical trial is for individuals with sebaceous hyperplasia, a condition where oil glands on the skin become enlarged. Participants should be willing to apply a topical cream and attend follow-up visits. Specific inclusion and exclusion criteria are not listed but typically involve age, health status, and other medical conditions.

Inclusion Criteria

I have large oil gland bumps on both sides of my face.

Ability to understand and willingness to sign a written informed consent

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.

Exclusion Criteria

I am not pregnant, nursing, or planning to become pregnant.

Current participation in other investigational trials

Known hypersensitivity to any of the following (in any dosage form): imiquimod or any component of the study medications

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive imiquimod treatment applied 3 times weekly for 8 weeks

8 weeks

Baseline and follow-up visits including photographs

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Imiquimod

Trial Overview The trial is testing whether applying Imiquimod 5% Topical Cream for 8 weeks can reduce the size of enlarged oil glands in patients with sebaceous hyperplasia. The study will monitor changes over the treatment period.

How Is the Trial Designed?

Group I: Imiquimod Experimental Treatment 1 Intervention

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

Group II: No treatment Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

Imiquimod applied three times a week for one or two shorter treatment courses resulted in a complete clearance rate of 26.8% after the first course and 53.7% overall, indicating its effectiveness in treating actinic keratosis.

After one year, recurrence rates were 39% for those treated with imiquimod, suggesting that while the treatment is effective, long-term follow-up is necessary due to the possibility of lesions returning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vehicle-controlled, double-blind, randomized study of imiquimod 5% cream applied 3 days per week in one or two courses of treatment for actinic keratoses on the head. Jorizzo, J., Dinehart, S., Matheson, R., et al.[2018]

The study developed nanostructured lipid carriers (NLCs) for imiquimod (IMQ), which significantly improved the drug's deposition in deeper skin layers compared to the commercial cream, enhancing its potential efficacy for treating skin conditions.

The optimized IMQ-NLC formulation was incorporated into a matrix-type patch, which not only improved drug delivery but also aimed to be more patient-friendly and environmentally sustainable, addressing common issues with topical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Optimization of Imiquimod-Loaded Nanostructured Lipid Carriers Using a Hybrid Design of Experiments Approach. Kim, S., Abdella, S., Abid, F., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06840470

Investigating the Effect of Topical Imiquimod on Sebaceous ... 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 ...

2. withpower.com withpower.com/trial/phase-4-sebaceous-hyperplasia-2-2025-b17c8

Imiquimod for Sebaceous Hyperplasia Imiquimod applied three times a week for one or two shorter treatment courses resulted in a complete clearance rate of 26.8% after the first course and 53.7% ...

3. trialx.com trialx.com/clinical-trials/listings/310042/investigating-the-effect-of-topical-imiquimod-on-sebaceous-hyperplasia/

Investigating the Effect of Topical Imiquimod on Sebaceous ... Overview. This study is being completed to determine if 8 weeks of treatment with imiquimod can shrink sebaceous hyperplasia.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12248929/

Topical 5% Imiquimod for the Treatment of Superficial and ... The findings showed that the cream was effective in eliminating tumors in most cases, especially when the lesions were small and superficial.

5. adisinsight.springer.com adisinsight.springer.com/trials/700380577

Investigating the Effect of Topical Imiquimod on Sebaceous ... This study is being completed to determine if 8 weeks of treatment with imiquimod can shrink sebaceous hyperplasia.

6. go.drugbank.com go.drugbank.com/drugs/DB00724

Imiquimod: Uses, Interactions, Mechanism of Action Imiquimod is a toll-like receptor 7 agonist used to treat non hyperkeratotic, non hypertrophic actinic keratosis, basal cell carcinoma, genital or perianal ...