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Optical Clearing of the Skin in Conjunction With Laser Treatments

Primary Purpose

Port Wine Stain, Nevus of Ota, Tattoos

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Optical Clearing
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Port Wine Stain focused on measuring sebaceous hyperplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beckman Laser Institute Medical and Surgical Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Optical Clearing

Arm Description

Optical Clearing

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2007
Last Updated
October 19, 2022
Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT00580736
Brief Title
Optical Clearing of the Skin in Conjunction With Laser Treatments
Official Title
Optical Clearing of the Skin in Conjunction With Laser Treatments
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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 laser treatment of vascular lesions as compared to the laser 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port Wine Stain, Nevus of Ota, Tattoos, Scars, Acne, Hypertrichosis, Sebaceous Gland Diseases
Keywords
sebaceous hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optical Clearing
Arm Type
Experimental
Arm Description
Optical Clearing
Intervention Type
Device
Intervention Name(s)
Optical Clearing
Intervention Description
Optical Clearing
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen M Kelly, M.D
Organizational Affiliation
Beckman Laser Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beckman Laser Institute Medical and Surgical Clinic
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States

12. IPD Sharing Statement

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Optical Clearing of the Skin in Conjunction With Laser Treatments

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