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

Primary Purpose

Hypertrichosis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Soprano/SHR

LightSheer

About this trial

This is an interventional treatment trial for Hypertrichosis focused on measuring Hair removal, Laser, Diode laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects must be at least 18 years of age.
Subjects must be in reasonably good health as defined by the Investigator.
Subject agrees to avoid tanning during their participation in this trial.
Subject has Fitzpatrick skin types I-V and dark brown hair.
Subjects must agree to avoid shaving legs less than 72 hours prior to a study visit.
Subjects have indicated willingness to participate in the study by signing an informed consent document.

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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Sites / Locations

Department of Dermatology Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Soprano/SHR

LightSheer

Arm Description

Alma Soprano/SHR 810 nm Diode Laser

LightSheer Duet 810 nm diode laser

Outcomes

Primary Outcome Measures

Change in Hair Growth

% reduction from baseline hair count at time points 1 month, 6 months and 12 months [following last (5th laser) treatment]

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT01212172

First Posted

September 22, 2010

Last Updated

January 7, 2016

Sponsor

University of California, Irvine

1. Study Identification

Unique Protocol Identification Number

NCT01212172

Brief Title

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

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Irvine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertrichosis

Keywords

Hair removal, Laser, Diode laser

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Soprano/SHR

Arm Type

Active Comparator

Arm Description

Alma Soprano/SHR 810 nm Diode Laser

Arm Title

LightSheer

Arm Type

Active Comparator

Arm Description

LightSheer Duet 810 nm diode laser

Intervention Type

Device

Intervention Name(s)

Soprano/SHR

Other Intervention Name(s)

Soprano/SHR laser

Intervention Description

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

Intervention Name(s)

LightSheer

Other Intervention Name(s)

Duet LightSheer

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Hair Growth

Description

% 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

Secondary Outcome Measure Information:

Title

Pain Rating Scale

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must be at least 18 years of age. Subjects must be in reasonably good health as defined by the Investigator. Subject agrees to avoid tanning during their participation in this trial. Subject has Fitzpatrick skin types I-V and dark brown hair. Subjects must agree to avoid shaving legs less than 72 hours prior to a study visit. Subjects have indicated willingness to participate in the study by signing an informed consent document. 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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher B Zachary, MBBS, FRCP

Organizational Affiliation

University of California, Irvine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Dermatology Clinical Research

City

Irvine

State/Province

California

ZIP/Postal Code

92697

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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