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

Purpose

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.

Condition	Intervention	Phase
Port Wine Stain Benign Vascular Lesion Nevus of Ota Tattoos Scars Acne Hypertrichosis Sebaceous Gland Diseases	Procedure: Optical coherence tomography (OCT) imaging and reflectance measurements	Phase I

Genetics Home Reference related topics:

Skin Pigmentation Disorders

MedlinePlus related topics:

Acne Birth Defects Hair Diseases and Hair Loss Moles Scars Skin Conditions Skin Pigmentation Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	Optical Clearing of the Skin in Conjunction With Laser Treatments

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	50
Study Start Date:	March 2004
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Procedure: Optical coherence tomography (OCT) imaging and reflectance measurements clearing agent, pre-polymers of polypropylene glycol and polyethylene glycol and photographs

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580736

Locations


United States, California
	Beckman Laser Institute Medical and Surgical Clinic
	Irvine, California, United States, 92612

Sponsors and Collaborators

University of California, Irvine

Beckman Laser Institute Medical Clinic

Bertek Pharma Div of Mayland.

Candelar Corporation

Investigators


Principal Investigator:	Kristen M Kelly, M.D	Beckman Laser Institute

More Information

Responsible Party:	Beckman Laser Institute ( Kristen Kelly,M.D )
Study ID Numbers:	RR-01192:PHS-NIH, P41-01192;NIH-LAMMP
First Received:	December 18, 2007
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00580736
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

sebaceous hyperplasia

Study placed in the following topic categories:

Skin Diseases

Nevi flammei, familial multiple

Port-Wine Stain

Skin Abnormalities

Sebaceous Gland Diseases

Acne Vulgaris

Melanoma

Nevus of Ota

Hyperplasia

Nevus, Pigmented

Connective Tissue Diseases

Infant, Newborn, Diseases

Nevus

Congenital Abnormalities

Hypertrichosis

Cicatrix

Additional relevant MeSH terms:

Skin and Connective Tissue Diseases

Hair Diseases

Neoplasms

Neoplasms by Histologic Type

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Nevi and Melanomas

ClinicalTrials.gov processed this record on May 15, 2008

Sponsors and Collaborators:	University of California, Irvine Beckman Laser Institute Medical Clinic Bertek Pharma Div of Mayland. Candelar Corporation
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00580736