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

NCT01212172 | Completed Phase 3 Results DMC

• 1 other identifier: 2010-7704
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrichosis

Keywords

Hair removal; Laser; Diode laser

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Pain Rating Scale

  12 months

Study Arms (2)

Soprano/SHR

ACTIVE COMPARATOR

Alma Soprano/SHR 810 nm Diode Laser

Device: Soprano/SHR

LightSheer

ACTIVE COMPARATOR

LightSheer Duet 810 nm diode laser

Device: LightSheer

Interventions

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.

Also known as: Soprano/SHR laser

Soprano/SHR

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.

Also known as: Duet LightSheer

LightSheer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Department of Dermatology Clinical Research

Irvine, California, 92697, United States

Location

Related Links

• UC Irvine Department of Dermatology Clinical Research

MeSH Terms

Conditions

Hypertrichosis

Condition Hierarchy (Ancestors)

Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Christopher B. Zachary
• Organization: UC Irvine Dermatology Research Center

czachary@uci.edu

949 824 7103

Study Officials

• Christopher B Zachary, MBBS, FRCP

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS, FRCP

Study Record Dates

• First Submitted: September 22, 2010
• First Posted: September 30, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 5, 2016
• Results First Posted: February 5, 2016

Record last verified: 2015-10

Locations

US (1)