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

Trial Summary

What is the purpose of this trial?

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

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.

Is imiquimod generally safe for use in humans?

Imiquimod is generally considered safe for use in humans, with common side effects being redness and erosion at the application site. It is FDA-approved for treating certain skin conditions like anogenital warts, actinic keratosis, and superficial basal cell carcinomas, and has been used safely in various other skin disorders. ^{1 2 3 4 5}

How does the drug imiquimod differ from other treatments for sebaceous hyperplasia?

Imiquimod is unique because it is an immune response modifier that works by activating the body's immune system to fight abnormal skin growths, unlike other treatments that may not engage the immune system. It is applied topically as a cream, which can be done at home, offering a non-invasive option with good cosmetic results. ^{6 7 8 9 10}

What data supports the effectiveness of the drug Imiquimod for treating sebaceous hyperplasia?

Imiquimod has been shown to be effective in treating various skin conditions like actinic keratoses (rough, scaly patches on the skin) and superficial basal cell carcinomas (a type of skin cancer) due to its ability to stimulate the immune system. This suggests it might also help with sebaceous hyperplasia, as it can influence skin conditions that are affected by the immune system. ^{2 9 11 12 13}

Research Team

Sunny Wong, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of 5% imiquimod cream for the treatment of skin dysplasia in high-risk renal transplant recipients: randomized, double-blind, placebo-controlled trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Innovative uses of imiquimod. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Complete clearance is sustained for at least 12 months after treatment of actinic keratoses of the face or balding scalp via daily dosing with imiquimod 3.75% or 2.5% cream. [2018]

4. United States 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. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Comparative study of imiquimod 3.75% vs. photodynamic therapy for actinic keratosis of the scalp. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Eruptive epidermoid cysts resulting from treatment with imiquimod. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Vehicle-controlled, randomized, double-blind study to assess safety and efficacy of imiquimod 5% cream applied once daily 3 days per week in one or two courses of treatment of actinic keratoses on the head. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Multiple 16-week Courses of Topical Imiquimod for the Treatment of Large Areas of Skin Involved with Actinic Keratoses. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Imiquimod in dermatology: an overview. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Imiquimod as a possible treatment for keratoacanthoma. [2020]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Development and Optimization of Imiquimod-Loaded Nanostructured Lipid Carriers Using a Hybrid Design of Experiments Approach. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Imiquimod as a dermatological therapy. [2019]

13. Hungary pubmed.ncbi.nlm.nih.gov

[New perspective in immunotherapy: local imiquimod treatment]. [2018]