A pilot study: pirfenidone, 8% (KitosCell) as a treatment for striae distensae

Abstract

Striae distensae (SD; stretch marks) are well-recognized skin lesions that occur in a large percentage of the population. Although they rarely cause significant medical concern, they can be a source of extreme physiological stress to affected patients. They occur commonly in pregnancy, puberty and obesity, but also become manifest following various medical conditions and therapeutic interventions. The precise etiological mechanism of SD has yet to be determined, however numerous theories have been proposed and risk factors have been identified. To date, there are many different treatment modalities to improve size and color of striae including diet and exercise, topical and laser therapies and surgery but none have demonstrated a consistent effectiveness. This unmet medical need may be addressed by the use of Pirfenidone. Pirfenidone is a small synthetic non-peptide molecule of low molecular weight (185.2 Daltons) that has been identified to have immuno-modulatory and anti-inflammatory properties. Clinical evidence indicates that Pirfenidone can modulate collagenase and fibroblastic activity by the modulation of cytokines in the wound healing process, such as TFG-β and TNF-α, which lead to effective collagen remodeling. Pirfenidone has exhibited low-toxicity in pre-clinical and clinical studies. These in vitro and in vivo findings suggest that Pirfenidone may be a safe and effective treatment of patients with SD.