Sebaceous Hyperplasia
Conditions
Keywords
Lesions on both sides of the face, Topical imiquimod
Brief summary
This study is being completed to determine if 8 weeks of treatment with imiquimod can shrink sebaceous hyperplasia.
Interventions
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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each subject's face will be divided randomly into an imiquimod-treated side and an untreated control side.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete and 75% clearance rates (clearance refers to reduction in total lesional area) at 16 weeks of treated lesions | 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in Sebaceous Hyperplasia (SH) count | 16 weeks | — |
| Mean change in Sebaceous Hyperplasia (SH) diameter | 16 weeks | — |
| Adverse events (AE) associated with imiquimod 5% cream when used in the treatment of sebaceous hyperplasia | Up to 8 weeks | The following will be described for Adverse events per protocol: * Serious or non-serious * Mild, moderate, Severe * The relationship (unexpected or expected) of the study drug * Attribution of the AE: Definite, Probably, Possible, Unlikely, Unrelated. |
Countries
United States
Contacts
Primary ContactJoseph Durgin, MD, MSc
Backup ContactMio Nakamura, MD
Outcome results
None listed