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Sponsors and Collaborators: |
University of California, Irvine Beckman Laser Institute University of California Irvine Bertek Pharma Div of Mayland. Candela Corporation |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00580736 |
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 |
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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 I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Optical Clearing of the Skin in Conjunction With Laser Treatments |
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 |
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1: Experimental |
Procedure: Optical coherence tomography (OCT) imaging and reflectance measurements
clearing agent, pre-polymers of polypropylene glycol and polyethylene glycol and photographs
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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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Beckman Laser Institute Medical and Surgical Clinic | |
Irvine, California, United States, 92612 |
Principal Investigator: | Kristen M Kelly, M.D | Beckman Laser Institute |
Responsible Party: | Beckman Laser Institute ( Kristen Kelly,M.D ) |
Study ID Numbers: | RR-01192:PHS-NIH, P41-01192;NIH-LAMMP |
Study First Received: | December 18, 2007 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00580736 History of Changes |
Health Authority: | United States: Institutional Review Board |
sebaceous hyperplasia |
Skin Diseases Port-Wine Stain Skin Abnormalities Sebaceous Gland Diseases Acne Vulgaris Melanoma Nevus of Ota |
Hyperplasia Nevi Flammei, Familial Multiple Nevus, Pigmented Nevus Congenital Abnormalities Hypertrichosis Cicatrix |
Hair Diseases Neoplasms by Histologic Type Skin Diseases Port-Wine Stain Skin Abnormalities Sebaceous Gland Diseases Nevus of Ota |
Neoplasms Nevus, Pigmented Nevi and Melanomas Nevus Congenital Abnormalities Hypertrichosis |