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The purpose of this research study is to compare two different 810 diode laser systems (Soprano XL (SHR Mode)and Light Sheer Duet) for laser hair removal. The goal is to determine if each laser system is effective at reducing the amount of hair on the lower legs or the axilla (arm pit). Another goal is determine the subject's perspective on the treatment including tolerability and effectiveness.
This side-by-side split body, blinded, randomized single-center study is comparing two different 810 nm diode laser technologies for the purpose of permanent hair reduction to determine the effectiveness and subject's tolerance for hair reduction. Twenty volunteers will be enrolled into this study. Subjects will receive a total of 5 treatments of either axilla or lower legs. 10 patients will have both axilla treated while the other 10 subjects will have the lower legs treated. Placement to the axilla treatment group vs. the lower leg treatment group is random.
Treatment areas will be randomized to receive Soprano SHR treatment or Light Sheer/Duet treatment. One extremity (example: right axilla) will receive Soprano SHR treatment and the contra-lateral extremity (example: left axilla) will receive Duet treatment. The treatments will occur every 6 - 8 weeks and then there will be follow up visits at 1 month, 6 months, and 12 months after the last treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soprano/SHR | Active Comparator | Alma Soprano/SHR 810 nm Diode Laser |
|
| LightSheer | Active Comparator | LightSheer Duet 810 nm diode laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soprano/SHR | Device | For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hair Growth | % reduction from baseline hair count at time points 1 month, 6 months and 12 months [following last (5th laser) treatment] | 1 month, 6 month, 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Rating Scale | Pain during each treatment was measured subjectively by patients on a 0-10 visual analogue scale (0=no pain, 10=unbearable pain). | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Subject is pregnant, lactating, or planning to get pregnant within the study period.
Subject is unwilling to use birth control during the study period if of child bearing age.
Subject has a known history of photosensitivity or use of medication with photosensitizing properties.
Subject has skin disease on exam at screening.
Subject has history or evidence of any chronic or reoccurring skin disease or disorder(e.g., psoriasis, Netherton syndrome, etc.) affecting the treatment area.
Subject has a history of keloid or hypertrophic scar formation.
Subject has a tattoo in the treatment area.
Subject has been tanning within the past 30 days.
Subject has history of confounding cancerous or pre-cancerous skin lesions in the treatment area.
Subject has used prohibited therapies (electrolysis, threading, waxing, depilatory), prohibited oral prescription medications (isotretinoin, steroids), or prohibited topical meds (steroids) on the treatment area within 30 days prior to enrollment.
Subject is unwilling to discontinue use of above listed prohibitive therapies for the duration of treatment.
Subject has a history of laser hair removal in the treatment area.
Subject has participated in any clinical trial involving an investigational drug or cosmetic product or procedure within the past 30 days.
The investigator feels that for any reason the subject is not eligible to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher B Zachary, MBBS, FRCP | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology Clinical Research | Irvine | California | 92697 | United States |
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| Label | URL |
|---|---|
| UC Irvine Department of Dermatology Clinical Research | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Soprano Duet 810 nm Diode Laser | Soprano Duet 810 nm diode laser Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time. |
| FG001 | LightSheer Duet 810 nm Diode Laser | Soprano and LightSheer Duet 810 nm diode laser LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Side-by Side Comparsion of Soprano/SHR to Light Sheer | Alma Soprano/SHR 810 nm Diode Laser Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time. LightSheer Duet 810 nm diode laser LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings. |
| 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 | Change in Hair Growth | % reduction from baseline hair count at time points 1 month, 6 months and 12 months [following last (5th laser) treatment] | Posted | Mean | Standard Deviation | % hair reduction | 1 month, 6 month, 12 month |
|
At each laser treatment visit and all post-laser treatment follow-up visits (1 month, 6 months, 12 months)
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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 | Soprano/SHR 810 nm Diode Laser | Alma Soprano/SHR VS Light Sheer Duet 810 nm Diode Lasers Right Axilla or Lower Leg Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burn | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher B. Zachary | UC Irvine Dermatology Research Center | 949 824 7103 | czachary@uci.edu |
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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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| LightSheer | Device | The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings. |
|
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
LightSheer Duet 810 nm diode laser
LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings.
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| Secondary | Pain Rating Scale | Pain during each treatment was measured subjectively by patients on a 0-10 visual analogue scale (0=no pain, 10=unbearable pain). | Posted | Median | 95% Confidence Interval | Units on a Scale | 12 months |
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| 0 |
| 20 |
| 6 |
| 20 |
| EG001 | Light Sheer 810 nm Diode Laser | Light Sheer 810 nm Diode Laser Left Axilla or Lower Leg LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings. | 0 | 20 | 5 | 20 |
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