NCT00366964

Brief Summary

This study is being done to compare the efficacy of an FDA cleared laser device with other similar systems in the market for the treatment of leg veins and hair removal in patients with darker skin type.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2006

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

1.5 years

First QC Date

August 19, 2006

Last Update Submit

April 6, 2015

Conditions

Leg VeinsHair Removal

Outcome Measures

Primary Outcomes (1)

  • Safety and efficacy of the treatment will determine the outcome.

    6 months

Study Arms (1)

Device

NO INTERVENTION
Device: Laser TreatmentDevice: Wave Light laser device for skin treatment

Interventions

Laser TreatmentDEVICE

The laser treatment involves the use of an FDA approved laser device (510K Clearance certificate) for hair removal and treatment of leg veins for females having skin types III - VI. The pulses are of appropriate energy and pulse duration based on the skin type.

Device
Wave Light laser device for skin treatmentDEVICE

To determine efficacy of FDA approved Laser treatment for hair removal and leg veins. The Mydon Wavelight is a Long Pulsed Nd Yag Laser, Class IV 1064 nm 55W

Device

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients of Asian and darker skin type greater than or equal to 18 years of age.
  • Ability to give informed consent.

You may not qualify if:

  • Pregnancy.
  • Taking medications that are photosensitizing.
  • History of skin disease in the area to be treated over the last 6 months.
  • Ongoing cutaneous lupus erythematosus, morphea, alopecia areata, or severe folliculitis.
  • History of keloidal or hypertrophic scarring.
  • Have inadequate hair growth in the test area of axilla.
  • Have unrealistic expectations of the treatment.
  • Co-existing severe emotional, medical or surgical illness leading to the inability to meet the follow-up requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis Medical Center Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Links

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Daniel B Eisen, M.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2006

First Posted

August 22, 2006

Study Start

October 1, 2004

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

US(1)