Clinical trial NCT01212172: Comparison of Efficacy, Safety and Tolerability of Two Different 810 nm Diode Lasers for Hair Reduction
Official title: Side-by-Side Comparison of 810 nm Diode Laser Technology With Low Fluence-High Repetition Rate vs Low Fluence-Vacuum Assist - A Split - Extremity Efficacy , Safety and Tolerability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertrichosis
Keywords: Hair removal
Laser
Diode laser
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2010-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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Primary outcomes:
measure: Change in Hair Growth
timeFrame: 1 month, 6 month, 12 month
Secondary outcomes:
measure: Pain Rating Scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Department of Dermatology Clinical Research
state: California
Study officials:
affiliation: University of California, Irvine
name: Christopher B Zachary, MBBS, FRCP
role: PRINCIPAL_INVESTIGATOR
References: