Photodynamic TherapyNCT04223570
Portable Measurement of Protoporphyrin IX in the Skin
An observational study of Photodynamic Therapy and Protoporphyrin IX, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Photodynamic therapy (PDT) is increasingly used to treat superficial skin lesions, such as actinic keratosis (AK) and non-melanoma skin cancers, and has been demonstrated to be an effective and safe alternative to surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photodynamic Therapy, Protoporphyrin IX
- What is being tested?
- Portable Apple Smart Phone Protoporphyrin IX Spectrometer Camera
- Type of treatment
- Medical device
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 20 May 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient subjects will be recruited at the DHMC outpatient dermatology clinic. Patients presenting for their routine sessions or regularly scheduled follow-up dermatology appointments will be provided information about the study. Employees at this location will also have the opportunity to participate.
Who may be able to join
- All patients and staff appearing at the Dartmouth-Hitchcock Medical Center Heater Road Dermatology Clinic who are aged 18 years and older
Who cannot join
- Pregnant women
- Women who are breast-feeding
- Adults unable to consent
- Individuals who are not yet adults
- Prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center Heater Road Clinic
Lebanon, New Hampshire, 03766
About this study
Photodynamic therapy (PDT) is increasingly used to treat superficial skin lesions, such as actinic keratosis (AK) and non-melanoma skin cancers, and has been demonstrated to be an effective and safe alternative to surgery. It is performed by applying a photosensitizing pro-drug, amino -levulinic acid (ALA) and then allowing the conversion to the metabolite Protoporphyrin IX (PpIX). While attempts to measure the concentration of this drug in the skin have been performed before, there remains limited research on an individuals' baseline level of PpIX which could lead to the customization of PDT. With the development of a new handheld, smart phone-associated device to measure red fluoresce intensity of PpIX, this measurement is now feasible. This is an observational single center quantitative study in which the investigators will take measurements of red fluoresce intensity of PpIX at various locations. This will then be correlated with the individuals age, oral temperature, diet, and skin type. The investigators hypothesize that the levels of PpIX will depend on all of these factors, including anatomical location. All data will be collected into the data collection form and then analyzed. The investigators will assess for how anatomical location, skin pigmentation, oral temperature, and other factors influence PpIX levels. Fitzpatrick skin type will be assessed by the provider to assess skin pigmentation. All of these factors will be correlated to the PpIX levels in 5 anatomical locations (forehead, cheeks, forearms, hands, and bald scalp where applicable) to determine which factors most greatly influence the red fluoresce intensity of PpIX.
Read the detailed description
Photodynamic Therapy (PDT) has gained popularity as an effective, non-scarring treatment for thin, non-hyperkeratotic actinic keratoses (AKs). Similar to the topical agents 5-fluorouracil and imiquimod, PDT is particularly useful when utilized as a field-directed therapy for the treatment of areas with multiple AKs and extensive sun damage. PDT consists of two steps: 1) the topical application of a photosensitizer agent aminolevulinic acid (ALA), which is preferentially converted to the photosensitive protoporphyrin IX (PpIX) in precancerous and neoplastic cells, and 2) controlled exposure to a visible wavelength light source. Current methodologies utilize a "one-size-fits-all" approach with regard to duration of incubation with photosensitizing agents and illumination. Moreover, patients frequently experience pain after long PDT prodrug incubation. Better characterization of photosensitization in PDT can help tailor incubation and overall treatment time to minimize treatment duration and discomfort while maximizing clearance of the target lesions. The direct measurement of PpIX is a promising, yet rarely performed test that may help determine the appropriate PDT treatment time, the need for re-treatment or adjuvant therapy, and potential efficacy of treatment. Point-probe measurements have shown extreme heterogeneity between PpIX levels in different patients and among different lesions in the same patient. However, these point-probe measurements are unable to account for the variance in PpIX production in different parts of the skin because of their relatively limited field of view. The recent development of a low-cost, smart phone-based, wide-field fluorescence dosimetry imaging system to map PpIX levels onto a 2D image allows for handheld, real-time analysis of PpIX levels in human skin. Initial unpublished clinical results have shown its utility in human subjects. However, a more extensive characterization of the factors that influence baseline in PpIX has yet to be performed. This study intends to elaborate these inter-and intra-individual variances, including analysis of changes in PpIX concentrations based on anatomical location, age, diet, temperature, pigmentation, and previous skin damage.
- Conditions
- Photodynamic Therapy, Protoporphyrin IX
- Being tested
- Portable Apple Smart Phone Protoporphyrin IX Spectrometer Camera
- Keywords
- Photodynamic Therapy, Actinic Keratoses, Protoporphyrin IX, Amino-levulinic acid
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable Apple Smart Phone Protoporphyrin IX Spectrometer CameraDevice
This is a portable device that uses a camera to non-invasively and efficiently measure the level of protoporphyrin IX in various areas skin. This camera will be used in all participants to measure the level of protoporphyrin IX in various areas of skin as detailed in the study description.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Protoporphyrin IX levels on the skin
Measure change in protoporphyrin IX levels in the skin of the forehead, malar cheek, dorsal hand, and dorsal forearm patients, as well as the bald scalp in male patients
Measured: At baseline
Secondary outcomes (6)
Effect of oral temperature on change in protoporphyrin IX levels at baseline and at serial time points after Ameluz application (the intervention)
Measure oral in temperature and compare it to protoporphyrin levels.
Measured: At baseline
Effect of age on change in protoporphyrin IX levels at baseline and at serial time points after Ameluz application (the intervention)
Determine the relationship of participant age with change in protoporphyrin IX levels
Measured: At baseline
Effect of Fitzpatrick skin type (skin pigmentation) on change in protoporphyrin IX levels
Determine the relationship of participant fitzpatrick skin type (skin pigmentation) with change in protoporphyrin IX levels
Measured: At baseline
Effect of diet on change in protoporphyrin IX levels
Determine the relationship of participant diet with change in protoporphyrin IX levels
Measured: At baseline
Effect of history of skin cancer on change in protoporphyrin IX levels
Determine the relationship of participant history of skin cancer with change in protoporphyrin IX levels
Measured: At baseline
Effect of sex on change in protoporphyrin IX levels
Determine the relationship of participant sex with change in protoporphyrin IX levels
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start1 Dec 2022
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Photodynamic TherapyStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael S. Chapman, Dartmouth-Hitchcock Medical Center
- Investigators
- Michael S Chapman, MD, MBA, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223570
- Sponsor's protocol ID
- D19167
- Status last verified
- May 2025
- First submitted
- 24 Dec 2019
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after being de-identified
Publications
Landes R, Illanes A, Goeppner D, Gollnick H, Friebe M. A study of concentration changes of Protoporphyrin IX and Coproporphyrin III in mixed samples mimicking conditions inside cancer cells for Photodynamic Therapy. PLoS One. 2018 Aug 31;13(8):e0202349. doi: 10.1371/journal.pone.0202349. eCollection 2018.
PubMed 30169536Anand S, Ortel BJ, Pereira SP, Hasan T, Maytin EV. Biomodulatory approaches to photodynamic therapy for solid tumors. Cancer Lett. 2012 Dec 29;326(1):8-16. doi: 10.1016/j.canlet.2012.07.026. Epub 2012 Jul 25.
PubMed 22842096Tyrrell JS, Morton C, Campbell SM, Curnow A. Comparison of protoporphyrin IX accumulation and destruction during methylaminolevulinate photodynamic therapy of skin tumours located at acral and nonacral sites. Br J Dermatol. 2011 Jun;164(6):1362-8. doi: 10.1111/j.1365-2133.2011.10265.x. Epub 2011 May 13.
PubMed 21564050Kanick SC, Davis SC, Zhao Y, Hasan T, Maytin EV, Pogue BW, Chapman MS. Dual-channel red/blue fluorescence dosimetry with broadband reflectance spectroscopic correction measures protoporphyrin IX production during photodynamic therapy of actinic keratosis. J Biomed Opt. 2014;19(7):75002. doi: 10.1117/1.JBO.19.7.075002.
PubMed 24996661Nissen CV, Heerfordt IM, Wiegell SR, Mikkelsen CS, Wulf HC. Increased protoporphyrin IX accumulation does not improve the effect of photodynamic therapy for actinic keratosis: a randomized controlled trial. Br J Dermatol. 2017 May;176(5):1241-1246. doi: 10.1111/bjd.15098. Epub 2017 Mar 8.
PubMed 27696393Kanick SC, Davis SC, Zhao Y, Sheehan KL, Hasan T, Maytin EV, Pogue BW, Chapman MS. Pre-treatment protoporphyrin IX concentration in actinic keratosis lesions may be a predictive biomarker of response to aminolevulinic-acid based photodynamic therapy. Photodiagnosis Photodyn Ther. 2015 Dec;12(4):561-6. doi: 10.1016/j.pdpdt.2015.10.006. Epub 2015 Oct 22.
PubMed 26480810Nissen CV, Philipsen PA, Wulf HC. Protoporphyrin IX formation after topical application of methyl aminolaevulinate and BF-200 aminolaevulinic acid declines with age. Br J Dermatol. 2015 Sep;173(3):760-6. doi: 10.1111/bjd.13923. Epub 2015 Aug 20.
PubMed 25997508Zhao B, He YY. Recent advances in the prevention and treatment of skin cancer using photodynamic therapy. Expert Rev Anticancer Ther. 2010 Nov;10(11):1797-809. doi: 10.1586/era.10.154.
PubMed 21080805Alberto J. Ruiz, Ethan P. M. LaRochelle, M. Shane Chapman, Tayyaba Hasan, Brian Pogue. Smartphone-based fluorescence imager for PpIX-based PDT treatment planning: System design and initial results. In: Vol 10860. ; 2019. https://doi.org/10.1117/12.2510403.
Rollakanti KR, Kanick SC, Davis SC, Pogue BW, Maytin EV. Techniques for fluorescence detection of protoporphyrin IX in skin cancers associated with photodynamic therapy. Photonics Lasers Med. 2013 Nov 1;2(4):287-303. doi: 10.1515/plm-2013-0030.
PubMed 25599015
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portable Measurement of Protoporphyrin IX in the Skin
- ClinicalTrials.gov ID
- NCT04223570
- Acronym / sponsor ID
- D19167
- Conditions
- Photodynamic Therapy, Protoporphyrin IX
- Keywords
- Photodynamic Therapy, Actinic Keratoses, Protoporphyrin IX, Amino-levulinic acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 10 Jan 2020 (actual)
- 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) is increasingly used to treat superficial skin lesions, such as actinic keratosis (AK) and non-melanoma skin cancers, and has been demonstrated to be an effective and safe alternative to surgery. It is performed by applying a photosensitizing pro-drug, amino -levulinic acid (ALA) and then allowing the conversion to the metabolite Protoporphyrin IX (PpIX). While attempts to measure the concentration of this drug in the skin have been performed before, there remains limited research on an individuals' baseline level of PpIX which could lead to the customization of PDT. With the development of a new handheld, smart phone-associated device to measure red fluoresce intensity of PpIX, this measurement is now feasible. This is an observational single center quantitative study in which the investigators will take measurements of red fluoresce intensity of PpIX at various locations. This will then be correlated with the individuals age, oral temperature, diet, and skin type. The investigators hypothesize that the levels of PpIX will depend on all of these factors, including anatomical location. All data will be collected into the data collection form and then analyzed. The investigators will assess for how anatomical location, skin pigmentation, oral temperature, and other factors influence PpIX levels. Fitzpatrick skin type will be assessed by the provider to assess skin pigmentation. All of these factors will be correlated to the PpIX levels in 5 anatomical locations (forehead, cheeks, forearms, hands, and bald scalp where applicable) to determine which factors most greatly influence the red fluoresce intensity of PpIX.
Detailed description
Photodynamic Therapy (PDT) has gained popularity as an effective, non-scarring treatment for thin, non-hyperkeratotic actinic keratoses (AKs). Similar to the topical agents 5-fluorouracil and imiquimod, PDT is particularly useful when utilized as a field-directed therapy for the treatment of areas with multiple AKs and extensive sun damage. PDT consists of two steps: 1) the topical application of a photosensitizer agent aminolevulinic acid (ALA), which is preferentially converted to the photosensitive protoporphyrin IX (PpIX) in precancerous and neoplastic cells, and 2) controlled exposure to a visible wavelength light source. Current methodologies utilize a "one-size-fits-all" approach with regard to duration of incubation with photosensitizing agents and illumination. Moreover, patients frequently experience pain after long PDT prodrug incubation. Better characterization of photosensitization in PDT can help tailor incubation and overall treatment time to minimize treatment duration and discomfort while maximizing clearance of the target lesions. The direct measurement of PpIX is a promising, yet rarely performed test that may help determine the appropriate PDT treatment time, the need for re-treatment or adjuvant therapy, and potential efficacy of treatment. Point-probe measurements have shown extreme heterogeneity between PpIX levels in different patients and among different lesions in the same patient. However, these point-probe measurements are unable to account for the variance in PpIX production in different parts of the skin because of their relatively limited field of view. The recent development of a low-cost, smart phone-based, wide-field fluorescence dosimetry imaging system to map PpIX levels onto a 2D image allows for handheld, real-time analysis of PpIX levels in human skin. Initial unpublished clinical results have shown its utility in human subjects. However, a more extensive characterization of the factors that influence baseline in PpIX has yet to be performed. This study intends to elaborate these inter-and intra-individual variances, including analysis of changes in PpIX concentrations based on anatomical location, age, diet, temperature, pigmentation, and previous skin damage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient subjects will be recruited at the DHMC outpatient dermatology clinic. Patients presenting for their routine sessions or regularly scheduled follow-up dermatology appointments will be provided information about the study. Employees at this location will also have the opportunity to participate.
Key inclusion criteria (1 listed)
- All patients and staff appearing at the Dartmouth-Hitchcock Medical Center Heater Road Dermatology Clinic who are aged 18 years and older
Key exclusion criteria (5 listed)
- Pregnant women
- Women who are breast-feeding
- Adults unable to consent
- Individuals who are not yet adults
- Prisoners.
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 |
|---|---|---|
| Portable Apple Smart Phone Protoporphyrin IX Spectrometer CameraThis is a portable device that uses a camera to non-invasively and efficiently measure the level of protoporphyrin IX in various areas skin. This camera will be used in all participants to measure the level of protoporphyrin IX in various areas of skin as detailed in the study description. | Device | – |
Primary outcome
Change in Protoporphyrin IX levels on the skin
Time frame: At baseline
Measure change in protoporphyrin IX levels in the skin of the forehead, malar cheek, dorsal hand, and dorsal forearm patients, as well as the bald scalp in male patients
6 secondary outcomes
Effect of oral temperature on change in protoporphyrin IX levels at baseline and at serial time points after Ameluz application (the intervention)
Time frame: At baseline
Effect of age on change in protoporphyrin IX levels at baseline and at serial time points after Ameluz application (the intervention)
Time frame: At baseline
Effect of Fitzpatrick skin type (skin pigmentation) on change in protoporphyrin IX levels
Time frame: At baseline
Effect of diet on change in protoporphyrin IX levels
Time frame: At baseline
Effect of history of skin cancer on change in protoporphyrin IX levels
Time frame: At baseline
Effect of sex on change in protoporphyrin IX levels
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 30169536Landes R, Illanes A, Goeppner D, Gollnick H, Friebe M. A study of concentration changes of Protoporphyrin IX and Coproporphyrin III in mixed samples mimicking conditions inside cancer cells for Photodynamic Therapy. PLoS One. 2018 Aug 31;13(8):e0202349. doi: 10.1371/journal.pone.0202349. eCollection 2018.
- Background: PubMed 22842096Anand S, Ortel BJ, Pereira SP, Hasan T, Maytin EV. Biomodulatory approaches to photodynamic therapy for solid tumors. Cancer Lett. 2012 Dec 29;326(1):8-16. doi: 10.1016/j.canlet.2012.07.026. Epub 2012 Jul 25.
- Background: PubMed 21564050Tyrrell JS, Morton C, Campbell SM, Curnow A. Comparison of protoporphyrin IX accumulation and destruction during methylaminolevulinate photodynamic therapy of skin tumours located at acral and nonacral sites. Br J Dermatol. 2011 Jun;164(6):1362-8. doi: 10.1111/j.1365-2133.2011.10265.x. Epub 2011 May 13.
- Background: PubMed 24996661Kanick SC, Davis SC, Zhao Y, Hasan T, Maytin EV, Pogue BW, Chapman MS. Dual-channel red/blue fluorescence dosimetry with broadband reflectance spectroscopic correction measures protoporphyrin IX production during photodynamic therapy of actinic keratosis. J Biomed Opt. 2014;19(7):75002. doi: 10.1117/1.JBO.19.7.075002.
- Background: PubMed 27696393Nissen CV, Heerfordt IM, Wiegell SR, Mikkelsen CS, Wulf HC. Increased protoporphyrin IX accumulation does not improve the effect of photodynamic therapy for actinic keratosis: a randomized controlled trial. Br J Dermatol. 2017 May;176(5):1241-1246. doi: 10.1111/bjd.15098. Epub 2017 Mar 8.
- Background: PubMed 26480810Kanick SC, Davis SC, Zhao Y, Sheehan KL, Hasan T, Maytin EV, Pogue BW, Chapman MS. Pre-treatment protoporphyrin IX concentration in actinic keratosis lesions may be a predictive biomarker of response to aminolevulinic-acid based photodynamic therapy. Photodiagnosis Photodyn Ther. 2015 Dec;12(4):561-6. doi: 10.1016/j.pdpdt.2015.10.006. Epub 2015 Oct 22.
- Background: PubMed 25997508Nissen CV, Philipsen PA, Wulf HC. Protoporphyrin IX formation after topical application of methyl aminolaevulinate and BF-200 aminolaevulinic acid declines with age. Br J Dermatol. 2015 Sep;173(3):760-6. doi: 10.1111/bjd.13923. Epub 2015 Aug 20.
- Background: PubMed 21080805Zhao B, He YY. Recent advances in the prevention and treatment of skin cancer using photodynamic therapy. Expert Rev Anticancer Ther. 2010 Nov;10(11):1797-809. doi: 10.1586/era.10.154.
- BackgroundAlberto J. Ruiz, Ethan P. M. LaRochelle, M. Shane Chapman, Tayyaba Hasan, Brian Pogue. Smartphone-based fluorescence imager for PpIX-based PDT treatment planning: System design and initial results. In: Vol 10860. ; 2019. https://doi.org/10.1117/12.2510403.
- Background: PubMed 25599015Rollakanti KR, Kanick SC, Davis SC, Pogue BW, Maytin EV. Techniques for fluorescence detection of protoporphyrin IX in skin cancers associated with photodynamic therapy. Photonics Lasers Med. 2013 Nov 1;2(4):287-303. doi: 10.1515/plm-2013-0030.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after being de-identified
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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.
Michael S Chapman, MD, MBA principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Photodynamic Therapy and Protoporphyrin IX, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Protoporphyrin IX levels on the skin (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04223570, which also lists 10 linked publications.
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 21 Nov 2025.