The Efficacy Of The Wavelight Mydon Laser for Hair Remova... | NCT00366964

Studies
The Efficacy Of The Wavelight Mydon Laser for Hair Removal And Treatment of Leg Veins

NCT00366964

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

Apr 7, 2015Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Leg Veins
Hair Removal

Interventions

Laser Treatment
Wave Light laser device for skin treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Apr 2006Actual

Completion Date

Apr 2006Actual

First Submitted Date

Aug 19, 2006

First Submission Date that Met QC Criteria

Aug 21, 2006

First Posted Date

Aug 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2015

Last Update Posted Date

Apr 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The specific aim of the study is to determine the efficacy of this FDA approved laser for hair removal and treatment of leg veins in female patients having darker skin types (Fitzpatrick Skin type III-VI) and compare it with the efficacy of other similar commercial units available in the U.S.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Device	No Intervention		Device: Laser Treatment Device: Wave Light laser device for skin treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser Treatment	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and efficacy of the treatment will determine the outcome.		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel B Eisen, M.D.	University of California, Davis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Davis Medical Center Department of Dermatology		Sacramento	California	95816	United States

References Module

Citations

Not provided

ID	Term
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative