Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is being completed to determine if 8 weeks of treatment with imiquimod can shrink sebaceous hyperplasia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imiquimod | Experimental | Will 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imiquimod 5% Topical Cream | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete and 75% clearance rates (clearance refers to reduction in total lesional area) at 16 weeks of treated lesions | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sunny Wong, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Each subject's face will be divided randomly into an imiquimod-treated side and an untreated control side.
Not provided
Not provided
Not provided
Not provided
|
|
The following will be described for Adverse events per protocol:
|
| Up to 8 weeks |
| D006571 | Heterocyclic Compounds |