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The purpose of this study is to compare treatment of sebaceous hyperplasia with pulsed dye laser (PDL) plus neodymium doped yttrium aluminum garnet laser (Nd:YAG) versus erbium doped yttrium aluminum garnet (erbium:YAG) laser versus electrodesiccation and curettage (ED&C).
This is a randomized clinical trial. Approximately 18 participants will enrolled. Each participant will have their sebaceous hyperplasia lesions randomized to receive either Erbium:YAG, PDL plus Nd:YAG, or ED&C treatment. Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Lesions will be treated twice, 2-6 weeks after the first treatment. Lesion size and count will be measured before treatment and at follow-up 4-12 weeks after the first treatment. This study is a pilot study designed to determine the feasibility of these procedures.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erbium:YAG Laser | Active Comparator | Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals. |
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| PDL plus Nd:YAG | Active Comparator | Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals. |
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| ED&C treatment | Active Comparator | Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erbium:YAG Laser | Device | Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in size of sebaceous hyperplasia | Change in size of sebaceous hyperplasia from baseline to 4-12 weeks after first treatment by measuring length and width in mm of each lesion. | 4-12 weeks |
| Change in sebaceous hyperplasia lesion count | Change in sebaceous hyperplasia lesion count from baseline to 4-12 weeks after first treatment | 4-12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Department of Dermatology | Chicago | Illinois | 60611 | United States |
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| Pulsed Dye Laser | Device | PDL will be performed using settings of 6-10 J/s2 on lesions. |
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| Nd:YAG Laser | Device | Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions. |
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| Electrodessication and curettage | Procedure | Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions. |
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|
| ID | Term |
|---|---|
| D054025 | Lasers, Dye |
| D003475 | Curettage |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D013514 | Surgical Procedures, Operative |
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