Hypertrichosis
Conditions
Keywords
Hair removal, Laser, Diode laser
Brief summary
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.
Detailed description
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.
Interventions
DEVICESoprano/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.
DEVICELightSheer
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.
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects must be at least 18 years of age. 2. Subjects must be in reasonably good health as defined by the Investigator. 3. Subject agrees to avoid tanning during their participation in this trial. 4. Subject has Fitzpatrick skin types I-V and dark brown hair. 5. Subjects must agree to avoid shaving legs less than 72 hours prior to a study visit. 6. Subjects have indicated willingness to participate in the study by signing an informed consent document.
Exclusion criteria
1. Subject is pregnant, lactating, or planning to get pregnant within the study period. 2. Subject is unwilling to use birth control during the study period if of child bearing age. 3. Subject has a known history of photosensitivity or use of medication with photosensitizing properties. 4. Subject has skin disease on exam at screening. 5. Subject has history or evidence of any chronic or reoccurring skin disease or disorder(e.g., psoriasis, Netherton syndrome, etc.) affecting the treatment area. 6. Subject has a history of keloid or hypertrophic scar formation. 7. Subject has a tattoo in the treatment area. 8. Subject has been tanning within the past 30 days. 9. Subject has history of confounding cancerous or pre-cancerous skin lesions in the treatment area. 10. 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. 11. Subject is unwilling to discontinue use of above listed prohibitive therapies for the duration of treatment. 12. Subject has a history of laser hair removal in the treatment area. 13. Subject has participated in any clinical trial involving an investigational drug or cosmetic product or procedure within the past 30 days. 14. The investigator feels that for any reason the subject is not eligible to participate in the study. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hair Growth | 1 month, 6 month, 12 month | % reduction from baseline hair count at time points 1 month, 6 months and 12 months \[following last (5th laser) treatment\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Rating Scale | 12 months | Pain during each treatment was measured subjectively by patients on a 0-10 visual analogue scale (0=no pain, 10=unbearable pain). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Side-by Side Comparsion of Soprano/SHR to Light Sheer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 20 | 5 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Change in Hair Growth
% reduction from baseline hair count at time points 1 month, 6 months and 12 months \[following last (5th laser) treatment\]
Time frame: 1 month, 6 month, 12 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Soprano/SHR | Change in Hair Growth | 1 month | 57.6 % hair reduction | Standard Deviation 34.03 |
| Soprano/SHR | Change in Hair Growth | 6 month | 39.3 % hair reduction | Standard Deviation 23.3 |
| Soprano/SHR | Change in Hair Growth | 12 month | 47.5 % hair reduction | Standard Deviation 38.41 |
| LightSheer | Change in Hair Growth | 1 month | 52.1 % hair reduction | Standard Deviation 32.2 |
| LightSheer | Change in Hair Growth | 6 month | 29.9 % hair reduction | Standard Deviation 21.7 |
| LightSheer | Change in Hair Growth | 12 month | 44.7 % hair reduction | Standard Deviation 43.2 |
p-value: 0.287995% CI: [-6.7, 21.1]t-test, 1 sided
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).
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Soprano/SHR | Pain Rating Scale | 3.6 Units on a Scale |
| LightSheer | Pain Rating Scale | 2.7 Units on a Scale |