Comparison of Efficacy, Safety and Tolerability of Two Different 810 nm Diode Lasers for Hair Reduction

NCT ID: NCT01212172

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-09-30

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.

Conditions

Hypertrichosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Soprano/SHR

Alma Soprano/SHR 810 nm Diode Laser

Group Type: ACTIVE_COMPARATOR

Soprano/SHR

Intervention Type: 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.

LightSheer

LightSheer Duet 810 nm diode laser

Group Type: ACTIVE_COMPARATOR

LightSheer

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

Soprano/SHR laser; Duet LightSheer

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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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Christopher Zachary

MBBS, FRCP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher B Zachary, MBBS, FRCP

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Department of Dermatology Clinical Research

Irvine, California, United States

Countries

United States

Related Links

http://www.dermatology.uci.edu/clinical_research.html

UC Irvine Department of Dermatology Clinical Research

Other Identifiers

2010-7704

Identifier Type: -

Identifier Source: org_study_id