Optical Clearing of the Skin in Conjunction With Laser Treatments

Phase 1

Completed

• Conditions: Nevus of Ota; Sebaceous Gland Diseases; Tattoos; Acne; Port Wine Stain; Scars; Hypertrichosis
• Interventions: Device: Optical Clearing

• Registration Number: NCT00580736
• Lead Sponsor: University of California, Irvine

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

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).

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2007-12-27
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optical Clearing	Optical Clearing	Optical Clearing

Primary Outcome Measures

Name	Time	Method
Outcome measure is to evaluate the optical clearing effects of the combination mixture of pre-polymers of polypropylene glycol and polyethylene glycol.	8 weeks

Trial Locations

Locations (1)

Beckman Laser Institute Medical and Surgical Clinic; 🇺🇸 Irvine, California, United States