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

NCT01256203 | Withdrawn Phase 2

• 1 other identifier: MA-PO-PHOTB05-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

PDT; Porfimer sodium; Phototoxicity; Sunscreen

Outcome Measures

Primary Outcomes (1)

• Skin erythema responses of control (unprotected) and Solar Protection Formula® SPF 60-protected sites to light exposure

  Skin erythema responses will be scored 24 hours after photobiological testing

  17 days

Secondary Outcomes (4)

• Skin erythema responses of control (unprotected) and Solar Protection Formula® SPF 60-protected sites to light exposure

  3 months

• Skin edema responses of control (unprotected) and Solar Protection Formula® SPF 60-protected sites to light exposure

  3 months

• Skin phototoxicity responses of control (unprotected) and Solar Protection Formula® SPF 60-protected sites to light exposure

  3 months

• Proportion of subjects with adverse events as a measure of safety

  3 months

Study Arms (1)

Sunscreen

EXPERIMENTAL

Solar Protection Formula SPF® 60 will be applied on the skin of each subject. Applications will be followed by photobiological testings to assess skin protection.

Drug: Solar Protection Formula SPF® 60; Procedure: Photobiological testing

Interventions

Solar Protection Formula SPF® 60 DRUG

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.

Sunscreen

Photobiological testing PROCEDURE

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.

Sunscreen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are males or females aged 18 or older.
• Subjects scheduled to undergo PDT with porfimer sodium for an approved indication.
• Fair-skin human subjects with skin types II or III (blond or red hair, freckles, blue or green eyes) according to Fitzpatrick Classification.
• Subjects must be entirely free of any vitamin A, provitamin A, beta-carotene supplements, or photosensitizing agents, taken orally or topically applied on the back area to be used for the skin photobiological testing procedures, for at least 30 days prior to the injection of porfimer sodium.
• Non-menopausal or non-sterile female subjects of childbearing potential must have a negative pregnancy test at the time of entry into the study.
• Non-menopausal or non-surgically sterilized female subjects of childbearing potential must use a medically acceptable form of birth control.
• Subjects must sign an Informed Consent Form, which must comply with the International Conference on Harmonisation (ICH) guidelines and local requirements.

You may not qualify if:

• Subjects who have received PDT during the six months prior to the date of the informed consent signature.
• Subjects who would likely need a second PDT course within 90 days.
• Subjects with clinically significant skin disorders, particularly in the back areas to be used for the skin photobiological testing procedures.
• Subjects with intensive pigmented skin, pre-existing redness, or significant growth of hair in the back area to be used for the skin photobiological testing procedures.
• Subjects with a presence or history of skin neoplasms.
• Subjects with jaundice or porphyria cutanea tarda.
• Subjects with frequent manifestations of vasomotor instability with flushing.
• Subjects suffering from end-stage malignancy.
• Known porphyria or hypersensitivity to sunlight or intense artificial light.
• Known contraindications or hypersensitivity/allergy to excipients contained in the sunscreen formula.
• Subjects with severe acute respiratory distress caused by an obstructing endobronchial lesion.
• Subjects with a presence or history of neoplasms (treated during the last five years prior to study entry) other than carcinoma in situ of the cervix.
• Subjects with esophageal or gastric varices.
• Subjects with severe renal or hepatic impairment.
• Subjects with tracheoesophageal or bronchoesophageal fistula.

Sponsors & Collaborators

• Pinnacle Biologics Inc.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Esophageal Neoplasms; Dermatitis, Phototoxic

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Photosensitivity Disorders; Skin Diseases, Eczematous

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 8, 2010
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 4, 2014

Record last verified: 2014-02