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

Tracking Information

First Received Date ^ICMJE

December 18, 2007

Last Updated Date

July 25, 2008

Start Date ^ICMJE

March 2004

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Outcome Measure are 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 ]

Change History

Complete list of historical versions of study NCT00580736 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Optical Clearing of the Skin in Conjunction With Laser Treatments

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

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

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00580736

Responsible Party

Kristen Kelly,M.D, Beckman Laser Institute

Study ID Numbers ^ICMJE

RR-01192:PHS-NIH, P41-01192;NIH-LAMMP

Study Sponsor ^ICMJE

University of California, Irvine

Collaborators ^ICMJE

Beckman Laser Institute University of California Irvine
Bertek Pharma Div of Mayland.
Candela Corporation

Investigators ^ICMJE

Principal Investigator:

Kristen M Kelly, M.D

Beckman Laser Institute

Information Provided By

University of California, Irvine

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP