Optical Clearing of the Skin in Conjunction With Laser Treatments

University of California Irvine (UCI)

Status and phase: Completed; Phase 1

Conditions: Scars; Hypertrichosis; Acne; Tattoos; Port Wine Stain; Sebaceous Gland Diseases; Nevus of Ota

Treatments: Device: Optical Clearing

Study type: Interventional

Funder types: Other

Identifiers

NCT00580736

20033442

Details and patient eligibility

About

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.

Full 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).

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Optical Clearing

Experimental group

Description:

Optical Clearing

Treatment:

Device: Optical Clearing