Optical Clearing of the Skin in Conjunction With Laser Treatments

NCT ID: NCT00580736

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2008-07-31

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).

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Optical Clearing

Optical Clearing

Group Type: EXPERIMENTAL

Optical Clearing

Intervention Type: DEVICE

Optical Clearing

Interventions

Optical Clearing

Optical Clearing

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Beckman Laser Institute and Medical Center

Kristen Kelly, M.D., Professor Departments of Dermatology and Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristen M Kelly, M.D

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute

Locations

Beckman Laser Institute Medical and Surgical Clinic

Irvine, California, United States

Countries

United States

Other Identifiers

20033442

Identifier Type: -

Identifier Source: org_study_id