Optical Clearing of the Skin in Conjunction With Laser Treatments

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00580736

Enrollment

Registered

2007-12-27

Start date

2004-03-31

Completion date

2008-07-31

Last updated

2022-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

sebaceous hyperplasia

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).

Interventions

DEVICEOptical Clearing

Optical Clearing

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026