Optical Clearing of the Skin in Conjunction With Laser Treatments - Tabular View

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Optical Clearing of the Skin in Conjunction With Laser Treatments

This study has been completed.
Information provided by University of California, Irvine

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Optical Clearing of the Skin in Conjunction With Laser Treatments

Official Title ^†

Optical Clearing of the Skin in Conjunction With Laser Treatments

Brief Summary

The research hypothesis is that topical application of a mixture of pre-polymers of polypropylene glycol and polyethylene glycol (an optical clearing agent) will reduce skin light scattering, increasing the amount of light reaching the target for diagnostic as well as therapeutic purposes.

Detailed Description

The researchers expect that application of the optical clearing agent for treatment of benign vascular lesions, tattoos, nevus of Ota, hypertrichosis, scars, acne and sebaceous hyperplasia will result in

decreased reflectance of the predominant color from the surface of skin (decreased red light scattering in case of benign vascular lesions, etc) as compared to the control group.
greater Optical Coherence Tomography (OCT- a non-invasive light based imaging method) imaging depth as compared to the control group.
greater improvement in the treatment outcome (decrease in the erythema index following PDL treatment of vascular lesions as compared to the PDL alone group; improved lightening of the tattoo or nevus of Ota as compared to the laser treatment alone group; significant decrease in hair re-growth as compared to laser treatment alone in patients seeking hair removal; greater improvement of scars, acne and sebaceous hyperplasia).

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Outcome measure is to evaluate the optical clearing effects of the combination mixture of pre-polymers of polypropylene glycol and polyethylene glycol. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measure ^†

Condition ^†

Port Wine Stain
Benign Vascular Lesion
Nevus of Ota
Tattoos
Scars
Acne
Hypertrichosis
Sebaceous Gland Diseases

Intervention ^†

Procedure: Optical coherence tomography (OCT) imaging and reflectance measurements

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

March 2004

Completion Date

July 2008

Eligibility Criteria ^†

Inclusion Criteria:

Adult 18 years and older
Lesion diagnoses in an area measuring 3 cm2 or more on any body site
Apparent good health

Exclusion Criteria:

Pregnant women
History of cutaneous photosensitivity
History of photodermatoses

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00580736

Organization ID

RR-01192:PHS-NIH

Secondary IDs ^††

P41-01192;NIH-LAMMP

Study Sponsor ^†

University of California, Irvine

Collaborators ^††

Beckman Laser Institute Medical Clinic
Bertek Pharma Div of Mayland.
Candelar Corporation

Investigators ^†

Principal Investigator:

Kristen M Kelly, M.D

Beckman Laser Institute

Information Provided By

University of California, Irvine

Verification Date

July 2008

First Received Date ^†

December 18, 2007

Last Updated Date

July 25, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.