Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-11

Study Completion Date

2027-09-11

Brief Summary

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

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Detailed Description

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Conditions

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Sebaceous Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each subject's face will be divided randomly into an imiquimod-treated side and an untreated control side.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imiquimod

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

Group Type EXPERIMENTAL

Imiquimod 5% Topical Cream

Intervention Type DRUG

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.

No treatment

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Imiquimod 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.

Intervention Type DRUG

Other Intervention Names

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Aldara

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No