Efficacy and Safety of a Sunscreen Against Porfimer Sodium-induced Phototoxicity to Visible Light

Esophageal Cancer Clinical Trial

Official title: Prospective, Randomized, Controlled, Partially Blinded, Skin Photobiological Clinical Study of the Efficacy and Safety of a Sunscreen Product as Skin Protector Against Porfimer Sodium-induced Phototoxicity to Visible Light

Status Withdrawn

Clinical Trial Summary

Photodynamic therapy (PDT) uses a combination of a drug, porfimer sodium, and a light from a non heated laser. The activation of the drug is done by illuminating abnormal areas using a fiber optic device. The fiber optic device is a very fine fiber (like fishing line) that permits transmission of light. By itself, porfimer sodium is inactive. However it becomes active when it is put in the presence of a light source such as sunlight, very intense indoor light, or laser. Therefore, the main risk with this therapy is that the skin will be more sensitive to light, and this sensibility can last up to 90 days. The skin reaction is similar to sunburn and is called phototoxicity.

To date, no product on the market has shown protection against visible light, and therefore, no product has been demonstrated to protect against the skin phototoxicity to visible light. A sunscreen sold under the brand name Solar Protection Formula® SPF 60 in the United States contains ingredients that provide maximum ultraviolet (UV) protection, as well as a formulation that could provide visible light protection. The product could potentially prevent the skin phototoxicity due to visible light, the most frequently reported side effect in patients receiving PDT with porfimer sodium. Therefore, this study is designed to assess the efficacy of topical application of Solar Protection Formula® SPF 60 as skin protector against visible light-induced skin redness and swelling following injection of porfimer sodium. It will involve 17 to 20 human subjects in the United States for whom PDT with porfimer sodium is planned for the treatment of high-grade dysplasia in Barrett's esophagus (pre-cancerous change in the food pipe tissue), lung cancer, or cancer of the esophagus (food pipe).

Clinical Trial Description

Human subjects with planned PDT course will be evaluated to confirm eligibility. Prior to enrollment, all inclusion and exclusion criteria will be verified. Medical procedures including demographic information (age, sex, race, smoking and drinking habits), medical/surgical history, physical exam (including vital signs, body weight, height, and skin color), clinical laboratory testing, concomitant medication intake and other therapy uses will be collected. The study procedures will begin after the intravenous injection of porfimer sodium.

Skin photobiological testing will consist of four 2-day periods performed over three months after the injection of porfimer sodium at a dose of 2 mg/kg of body weight. Each period will include a Skin Illumination session and a Skin Evaluation session. During the Skin Illumination session, the Solar Protection Formula® SPF 60 will be randomly applied at a dose of 2 mg/cm² on a skin subunit area of the back 30 minutes before illumination. A second skin subunit will be used as a "no-treatment" observational area. Therefore, each subject will be her/his own control. Illumination will be performed using a visible light source. During the Skin Evaluation session, skin reactions will be scored by an outcome assessor 24 hours after illumination according to a pre-determined rating scale. The outcome assessor will be blinded to the active treatment sequence applications. All subjects will be followed for three months. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Barrett Esophagus
• Carcinoma, Non-Small-Cell Lung
• Dermatitis, Phototoxic
• Esophageal Cancer
• Esophageal Neoplasms
• High-grade Dysplasia in Barrett Esophagus
• Non Small Cell Lung Cancer

• NCT number: NCT01256203
• Study type: Interventional
• Source: Pinnacle Biologics Inc.
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 2013
• Completion date: March 2014