Sebaceous HyperplasiaPhase 4NCT06840470
Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia
A Phase 4 study testing Imiquimod 5% Topical Cream in people with Sebaceous Hyperplasia, run by University of Michigan at 1 site in United States.
Trial summary
This study is being completed to determine if 8 weeks of treatment with imiquimod can shrink sebaceous hyperplasia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sebaceous Hyperplasia
- What is being tested?
- Imiquimod 5% Topical Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2025to 8 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study is being completed to determine if 8 weeks of treatment with imiquimod can shrink sebaceous hyperplasia.
- Conditions
- Sebaceous Hyperplasia
- Being tested
- Imiquimod 5% Topical Cream
- Keywords
- Lesions on both sides of the face, Topical imiquimod
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod 5% Topical CreamDrug
Also called Aldara
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.
| Study group | Role | What they receive |
|---|---|---|
| Imiquimod | Experimental | Will be applied 3 times weekly ((i.e. Monday, Wednesday, and Friday prior to bedtime) to one side of the face. Receives: Drug: Imiquimod 5% Topical Cream |
| No treatment | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete and 75% clearance rates (clearance refers to reduction in total lesional area) at 16 weeks of treated lesions
Measured: 16 weeks
Secondary outcomes (3)
Mean change in Sebaceous Hyperplasia (SH) count
Measured: 16 weeks
Mean change in Sebaceous Hyperplasia (SH) diameter
Measured: 16 weeks
Adverse events (AE) associated with imiquimod 5% cream when used in the treatment of sebaceous hyperplasia
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.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start11 Mar 2025
- Primary completion8 Apr 2026
- Study completion8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sebaceous HyperplasiaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each subject's face will be divided randomly into an imiquimod-treated side and an untreated control side.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunny Wong, University of Michigan
- Investigators
- Sunny Wong, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840470
- Sponsor's protocol ID
- HUM00262234
- Status last verified
- Aug 2026
- First submitted
- 17 Feb 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia
- ClinicalTrials.gov ID
- NCT06840470
- Acronym / sponsor ID
- HUM00262234
- Conditions
- Sebaceous Hyperplasia
- Keywords
- Lesions on both sides of the face, Topical imiquimod
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being completed to determine if 8 weeks of treatment with imiquimod can shrink sebaceous hyperplasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each subject's face will be divided randomly into an imiquimod-treated side and an untreated control side.
| Arm | Type | Receives |
|---|---|---|
| Imiquimod | Experimental | Drug: Imiquimod 5% Topical CreamWill be applied 3 times weekly ((i.e. Monday, Wednesday, and Friday prior to bedtime) to one side of the face. |
| No treatment | No 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imiquimod 5% Topical CreamAlso: AldaraParticipants 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. | Drug | Imiquimod |
Primary outcome
Complete and 75% clearance rates (clearance refers to reduction in total lesional area) at 16 weeks of treated lesions
Time frame: 16 weeks
3 secondary outcomes
Mean change in Sebaceous Hyperplasia (SH) count
Time frame: 16 weeks
Mean change in Sebaceous Hyperplasia (SH) diameter
Time frame: 16 weeks
Adverse events (AE) associated with imiquimod 5% cream when used in the treatment of sebaceous hyperplasia
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Sebaceous Hyperplasia
Enrolling by invitationPhase 2
Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial
Sebaceous Hyperplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunny Wong, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Imiquimod 5% Topical Cream in people with Sebaceous Hyperplasia, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete and 75% clearance rates (clearance refers to reduction in total lesional area) at 16 weeks of treated lesions (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.