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NCT00580736 Clinical Trial

Optical Clearing of the Skin in Conjunction With Laser Treatments

Acne Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00580736
Other study ID # 20033442
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 2004
Est. completion date July 2008

Study information
Verified date October 2022
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 1. 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. 2. greater Optical Coherence Tomography a non-invasive light based imaging method imaging depth as compared to the control group. 3. 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).

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Optical Clearing
Optical Clearing

Locations
Country Name City State
United States Beckman Laser Institute Medical and Surgical Clinic Irvine California

Sponsors (2)
Lead Sponsor Collaborator
University of California, Irvine Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Outcome measure is to evaluate the optical clearing effects of the combination mixture of pre-polymers of polypropylene glycol and polyethylene glycol. 8 weeks
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