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The purpose of this randomized, controlled, open-label pilot study is to evaluate the safety and efficacy of a novel intense pulsed light (IPL) device for removal of unwanted fine body hair.
Subjects will have IPL treatment on one forearm area. Another area will serve as the un-treated control area. Subjects will be followed at 12-weeks post-final treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prowave LX IPL | Experimental | One area on forearm will receive treatment with Prowave LX IPL |
|
| No Treatment | No Intervention | No treatment administered on one area of forearm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prowave LX IPL | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Percent Hair Reduction Between Treatment Arm and Non-treated Control Arm at 12 Weeks Post Final Treatment | 12-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Sadick | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sadick Research Group | New York | New York | 10075 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Each subject will receive hair removal treatments with the Prowave LX IPL. Each subject will have one designated treatment area on the foreman and one un-treated control area. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Subjects | All enrolled subjects receiving treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparison of Percent Hair Reduction Between Treatment Arm and Non-treated Control Arm at 12 Weeks Post Final Treatment | Posted | Mean | Full Range | percent reduction | 12-weeks |
|
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prowave LX IPL | Prowave LX IPL on one area of the forearm | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margot Doucette | Cutera | 415-657-5518 | mdoucette@cutera.com |
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| ID | Term |
|---|---|
| D006983 | Hypertrichosis |
| ID | Term |
|---|---|
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D062325 | Intense Pulsed Light Therapy |
| D006204 | Hair Removal |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
| D003357 | Cosmetic Techniques |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 11 |
| 0 |
| 11 |
| 5 |
| 11 |
| EG001 | No Treatment | No treatment administered. | 0 | 11 | 0 | 11 | 0 | 11 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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