High-grade Dysplasia in Barrett EsophagusPhase 2NCT01256203
Efficacy and Safety of a Sunscreen Against Porfimer Sodium-induced Phototoxicity to Visible Light
A Phase 2 study testing Solar Protection Formula SPF® 60 and Photobiological testing in people with High-grade Dysplasia in Barrett Esophagus and Non Small Cell Lung Cancer, run by Pinnacle Biologics Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-grade Dysplasia in Barrett Esophagus, Non Small Cell Lung Cancer, Esophageal Cancer
- What is being tested?
- Solar Protection Formula SPF® 60 and Photobiological testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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).
Read the detailed 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.
- Being tested
- Solar Protection Formula SPF® 60, Photobiological testing
- Keywords
- PDT, Porfimer sodium, Phototoxicity, Sunscreen
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms, Dermatitis, Phototoxic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solar Protection Formula SPF® 60Drug
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.
Photobiological testingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Solar Protection Formula SPF® 60; Procedure: Photobiological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 17 days
Secondary outcomes (4)
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 on three separate occasions over 3 months
Measured: 3 months
Skin edema responses of control (unprotected) and Solar Protection Formula® SPF 60-protected sites to light exposure
Skin edema responses will be scored 24 hours after photobiological testing on four separate occasions over 3 months
Measured: 3 months
Skin phototoxicity responses of control (unprotected) and Solar Protection Formula® SPF 60-protected sites to light exposure
Skin phototoxicity responses will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) 24 hours after photobiological testing on four separate occasions over 3 months
Measured: 3 months
Proportion of subjects with adverse events as a measure of safety
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startMay 2013
- Primary completionDec 2013 (estimated)
- Study completionMar 2014 (estimated)
Why it stopped: Sponsor cancelled the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade Dysplasia in Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pinnacle Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256203
- Sponsor's protocol ID
- MA-PO-PHOTB05-01
- Status last verified
- Feb 2014
- First submitted
- 7 Dec 2010
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01256203
- Acronym / sponsor ID
- MA-PO-PHOTB05-01
- Keywords
- PDT, Porfimer sodium, Phototoxicity, Sunscreen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor cancelled the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pinnacle Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 8 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunscreen | Experimental | Drug: Solar Protection Formula SPF® 60, Procedure: Photobiological testingSolar Protection Formula SPF® 60 will be applied on the skin of each subject. Applications will be followed by photobiological testings to assess skin protection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solar Protection Formula SPF® 60Solar 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. | Drug | Sunscreen |
| Photobiological testingPhotobiological 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. | Procedure or surgery | Sunscreen |
Primary outcome
Skin erythema responses of control (unprotected) and Solar Protection Formula® SPF 60-protected sites to light exposure
Time frame: 17 days
Skin erythema responses will be scored 24 hours after photobiological testing
4 secondary outcomes
Skin erythema responses of control (unprotected) and Solar Protection Formula® SPF 60-protected sites to light exposure
Time frame: 3 months
Skin edema responses of control (unprotected) and Solar Protection Formula® SPF 60-protected sites to light exposure
Time frame: 3 months
Skin phototoxicity responses of control (unprotected) and Solar Protection Formula® SPF 60-protected sites to light exposure
Time frame: 3 months
Proportion of subjects with adverse events as a measure of safety
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Solar Protection Formula SPF® 60 and Photobiological testing in people with High-grade Dysplasia in Barrett Esophagus and Non Small Cell Lung Cancer, run by Pinnacle Biologics Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin erythema responses of control (unprotected) and Solar Protection Formula® SPF 60-protected sites to light exposure (time frame: 17 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.