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

Sponsor:	Montana Compton
Collaborators:	Beckman Laser Institute University of California Irvine Bertek Pharma Divison of Mayland Candela Corporation
Information provided by (Responsible Party):	Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00580736

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Optical Clearing of the Skin in Conjunction With Laser Treatments

Resource links provided by NLM:

MedlinePlus related topics: Birthmarks Moles

U.S. FDA Resources

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 ]

Enrollment:	35
Study Start Date:	March 2004
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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

Montana Compton

Beckman Laser Institute University of California Irvine

Bertek Pharma Divison of Mayland

Candela Corporation

Investigators

Principal Investigator:

Kristen M Kelly, M.D

Beckman Laser Institute

More Information

No publications provided

Responsible Party:	Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00580736 History of Changes
Other Study ID Numbers:	RR-01192:PHS-NIH, P41-01192;NIH-LAMMP
Study First Received:	December 18, 2007
Last Updated:	October 28, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

sebaceous hyperplasia

Additional relevant MeSH terms:

Hypertrichosis
Hirsutism
Nevus of Ota
Sebaceous Gland Diseases
Port-Wine Stain
Hair Diseases
Skin Diseases
Virilism

Signs and Symptoms
Nevus, Pigmented
Nevus
Nevi and Melanomas
Neoplasms by Histologic Type
Neoplasms
Skin Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on February 12, 2012