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

NCT01256203 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-03-04

No results posted yet for this study

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).

Conditions

  • High-grade Dysplasia in Barrett Esophagus
  • Non Small Cell Lung Cancer
  • Esophageal Cancer

Interventions

DRUG

Solar Protection Formula SPF® 60

Solar Protection Formula SPF® 60 (2 mg/cm²) will be topically applied on a randomly predetermined specific skin area on the back of each subject on four separate occasions over 3 months. The same skin area will never be exposed more than once to the sunscreen.

PROCEDURE

Photobiological testing

Photobiological testing will consist of exposing a small area of the sunscreen-protected and unprotected (control) skin areas to visible light on four separate occasions over 3 months. Light will be applied 30 minutes after application of the sunscreen. The same skin area will never be exposed more than once to light.

Sponsors & Collaborators

  • Pinnacle Biologics Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-12-31
Completion
2014-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01256203 on ClinicalTrials.gov