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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


Phase 2
18 Years
N/A
Not Enrolling
Both
High-grade Dysplasia in Barrett Esophagus, Non Small Cell Lung Cancer, Esophageal Cancer

Thank you

Trial Information

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


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.


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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.

- Subjects with tumors eroding into a major blood vessel.

- Known contraindications or hypersensitivity/allergy to porfimer sodium.

- Subjects with esophageal ulcers > 1 cm in diameter.

- Female subjects who intend to become pregnant or intend to breast-feed during this
study.

- Subjects unable to attend all visits required for the skin photobiological testing
procedures.

- Subjects who have been treated with any investigational drug during 60 days prior to
the date of the informed consent signature.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

Skin erythema responses will be scored 24 hours after photobiological testing

Outcome Time Frame:

17 days

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

MA-PO-PHOTB05-01

NCT ID:

NCT01256203

Start Date:

May 2013

Completion Date:

March 2014

Related Keywords:

  • High-grade Dysplasia in Barrett Esophagus
  • Non Small Cell Lung Cancer
  • Esophageal Cancer
  • PDT
  • Porfimer sodium
  • Phototoxicity
  • Sunscreen
  • Barrett Esophagus
  • Carcinoma, Non-Small-Cell Lung
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Lung Neoplasms
  • Dermatitis, Phototoxic

Name

Location

Ohio State UniversityColumbus, Ohio  43210
St-Mary's Hospital (Mayo Clinic)Rochester, Minnesota  55905