SBIR-STTR Award

Disorders of cutaneous hyperpigmentation are a common problem causing substantial morbidity which ranges from cosmetic embarassment to social disgrace, depending on the extent of pigmentation and on racial extraction. At least 5% of patient visits to dermatologists are for these disorders for which there is no adequate therapy. Disorderswith increased epidermal pigmentation, such as lentigines (liver or sun spots) and ephelides (freckles) are most often treated only moderately effectively with cryotherapy. Results of treatment of dermal hyperpigmentation disorders such as post-inflammatory hyperpigmentation and tattoos are often worse than the initial disease. Effective therapy is sorely needed. Laser applications, inc. And the massachusetts general hospital have conducted preliminary studies with the q-switched ruby laser which hasdemonstrated selective damage of both epidermal and dermal pigment in pigmented guinea pigs leading to temporary hypopigmentation. Laser applications, inc. Plans to furtherinvestigate this effect both in animal models and in human skin. Specifically, the effects of q-switched ruby laser light will be studied in pigmented guinea pigs, in tattooed albino guinea pigs, in human subjects with normal cutaneous pigmentation, and in human subjects with increased epidermal pigmentation. We also plan to optimize the laser operating parameters of beam uniformity, pulse to pulse energy stability, q-switch longevity and beam transmission through fiberoptics. If successful, laser applications, inc. Will extend the studies to humans with dermal hyperpigmentation and will pursue the design and development of a clinical laser system in phase ii.

During Phase I, a superior nonscarring laser tretment for removing tattoos and an effective therapy for epidermal pigmented lesions were developed, using Q-switched ruby laser (QSRL) pulses. Phase II studies will:(1) implement and test Q-switched lasers designed specifically for dermatology,(2) treat a large number of tattoo patients at two clinical sites to fully assess responses,(3) further optimize tattoo therapy by controlled variation of pusewidth and wavelength,(4) perform a clinical dose-response study of epidermal and dermal hyperpigmentation using QSRL, and(5) produce and, if possible, optimize laser-induced leukotrichia (permanent hair bleaching).Controlled clinical, histologic, and electron microscopic observations will be used as endpoints. These studies should leead directly to improved therapies, FDA approval, and a highly favorable position for Laser Applications, Inc., within a new medical device market.Awardee's statement of the potential commercial applications of the research:The work will develop new applications of pulsed lasers for treatment of skin lesions and tattoos. Because of the limitations or lack of current therapy for these various conditions, the research is medically important. Because many of the conditions to be treated are common, a significant number of commercial applications exist.National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)