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Optical Clearing of the Skin in Conjunction With Laser Treatments

Phase 1
18 Years
Not Enrolling
Port Wine Stain, Benign Vascular Lesion, Nevus of Ota, Tattoos, Scars, Acne, Hypertrichosis, Sebaceous Gland Diseases

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Trial Information

Optical Clearing of the Skin in Conjunction With Laser Treatments

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

2. greater Optical Coherence Tomography (OCT- 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
PDL treatment of vascular lesions as compared to the PDL 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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Kristen M Kelly, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Laser Institute


United States: Institutional Review Board

Study ID:




Start Date:

March 2004

Completion Date:

July 2008

Related Keywords:

  • Port Wine Stain
  • Benign Vascular Lesion
  • Nevus of Ota
  • Tattoos
  • Scars
  • Acne
  • Hypertrichosis
  • Sebaceous Gland Diseases
  • sebaceous hyperplasia
  • Hypertrichosis
  • Hirsutism
  • Nevus of Ota
  • Sebaceous Gland Diseases
  • Port-Wine Stain
  • Cicatrix



Beckman Laser Institute Medical and Surgical Clinic Irvine, California  92612