Objectives: Treatment modalities for benign pigmented lesions range from cryotherapy to laser and energy-based technologies. These treatments have been shown to be effective, yet may lead to dyschromia or significant downtime. We report a novel Cooling System that provides localized and controlled freezing to benign pigmented lesions.
Introduction: Existing therapeutic modalities for treatment of benign pigmented lesions suffer certain limitations, including risks of post-inflammatory hyperpigmentation especially in susceptible ethnic populations and darker Fitzpatrick skin types. Prior experience with cutaneous cryotherapy has demonstrated the cold sensitivity of melanocytes. A novel device has been developed to deliver precise, controlled, localized cooling to effect a reduction in pigmentation without collateral damage to the epidermis. A GLP animal study was performed to evaluate the dosimetry and role of controlled skin cooling
Materials / method: Preclinical testing was performed in a porcine model. Two female Sinclair Yucatan pigs were treated on the flanks using the Dermal Cooling System. Different contact cooling applicators were used to deliver a range of temperatures and exposure times. Pigmentation changes were assessed by photographic review scoring, and biopsy samples were taken immediately following treatment and monthly thereafter for histopathology. Subsequently, clinical utilization of the Dermal Cooling System was initiated to assess the safety and effectiveness of the device and to evaluate treatment parameter ranges.
Results: In the GLP porcine study, specific exposure conditions were determined that consistently and safely elicited a reduction in pigmentation based on the photographic review. There was an absence of any notable side effects in the animals. Histologic evaluation revealed that localized epidermal cooling was associated with decreases in histomorphometric and histomorphologic pigmentation parameters without adverse tissue reactions. Clinical experience with the device is ongoing. Subjects with lentigines, seborrheic keratosis, melasma, or other hyperpigmentation conditions have been treated
Conclusion: Preclinical and clinical testing have demonstrated the ability to selectively and safely reduce pigmentation using controlled, localized cooling of the epidermis. The Dermal Cooling System provides an alternative to energy-delivery devices for treatment of benign pigmented lesions, offering minimal procedural discomfort and downtime, low risk of post-inflammatory hyperpigmentation, and the ability to treat all skin types.
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