Optical Clearing of the Skin in Conjunction With Laser Treatments
This study has been completed.
Sponsor:
Montana Compton
Collaborators:
Beckman Laser Institute University of California Irvine
Bertek Pharma Divison of Mayland
Candela Corporation
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00580736
First received: December 18, 2007
Last updated: October 28, 2011
Last verified: October 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Port Wine Stain Benign Vascular Lesion Nevus of Ota Tattoos Scars Acne Hypertrichosis Sebaceous Gland Diseases |
Procedure: Optical coherence tomography (OCT) imaging and reflectance measurements |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Optical Clearing of the Skin in Conjunction With Laser Treatments |
Resource links provided by NLM:
Further study details as provided by University of California, Irvine:
Primary Outcome Measures:
- Outcome measure is to evaluate the optical clearing effects of the combination mixture of pre-polymers of polypropylene glycol and polyethylene glycol. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 35 |
| Study Start Date: | March 2004 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Procedure: Optical coherence tomography (OCT) imaging and reflectance measurements
clearing agent, pre-polymers of polypropylene glycol and polyethylene glycol and photographs
|
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
- 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.
- greater Optical Coherence Tomography (OCT- a non-invasive light based imaging method) imaging depth as compared to the control group.
- 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 hyperplasia).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580736
Locations
| United States, California | |
| Beckman Laser Institute Medical and Surgical Clinic | |
| Irvine, California, United States, 92612 | |
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Bertek Pharma Divison of Mayland
Candela Corporation
Investigators
| Principal Investigator: | Kristen M Kelly, M.D | Beckman Laser Institute |
More Information
No publications provided
| Responsible Party: | Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00580736 History of Changes |
| Other Study ID Numbers: | RR-01192:PHS-NIH, P41-01192;NIH-LAMMP |
| Study First Received: | December 18, 2007 |
| Last Updated: | October 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
sebaceous hyperplasia |
Additional relevant MeSH terms:
|
Hypertrichosis Hirsutism Nevus of Ota Sebaceous Gland Diseases Port-Wine Stain Hair Diseases Skin Diseases Virilism |
Signs and Symptoms Nevus, Pigmented Nevus Nevi and Melanomas Neoplasms by Histologic Type Neoplasms Skin Abnormalities Congenital Abnormalities |
ClinicalTrials.gov processed this record on May 19, 2013