PhototoxicityPhototoxNCT06710600
Phototoxicity of Frequently Prescribed Medicines
A study testing Single oral dose of selected medicines, respectively and UVA and UVB radiation in people with Phototoxicity, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This pilot trial aims to study 10 selected commonly prescribed medicines with different grade of phototoxic potential. As there is no currently established way to assess phototoxic potential in a systematic and quantitative way, we want to test a novel radiation and measurement protocol to provide more granular… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Phototoxicity
- What is being tested?
- Single oral dose of selected medicines, respectively and UVA and UVB radiation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- 22 Sep 2022to 3 Oct 2024
- Phase
- Interventional
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Male or female 18-45 years of age (limits included)
- BMI 19-27 for males and BMI 17-25 for females
- Vital parameters at screening within normal limits
- Electrocardiogram without clinically significant pathologic abnormalities and with QTc values lesser than 450 ms
- Skin type II-IV on Fitzpatrick scale (table 1)
- Women of childbearing potential agree to use adequate birth control methods during the entire study period. For all females, negative pregnancy test at screening and once monthly is required. Acceptable methods of contraception include: oral contraceptives, intrauterine device, female or male condoms with spermicide, diaphragm with spermicide, contraceptive medication patch, contraceptive medication implant, contraceptive medication injection, abstinence, or surgical sterilization more than 3 months before randomization.
Who cannot join
- Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test
- Lack of willingness or capacity to co-operate and comply with the study procedures appropriately
- Failure to perform screening or baseline examinations
- Regular use of any medication (prescription or over the counter) for prevention or treatment of any medical condition in the previous 2 months except intake of contraceptives
- Intake of any medication throughout the active phase of the study that would interfere with the study procedure as per investigator's judgement
- Use of dietary supplements in the previous 4 weeks, incl St. John's Wort
Show all 24Show fewer
- Exposure to UV-radiation (including direct or indirect sun exposure, solarium, phototherapy) or use of oral sun-protective substances and self-tanning products 2 weeks prior to first medication administration and during the entire study duration
- Scars, previous trauma, tattoos or any other condition on the inner side of the arms that would impede the study procedures
- Evidence of active infection requiring antibiotic therapy within 14 days prior to screening
- Any chronic medical condition requiring chronic treatment, incl. liver disease, respiratory, cardiovascular or history of malignancies within the past two years or on current anticancer treatment
- History of gastrointestinal pathology such as gastritis, gastric ulcers, irritable bowel disease, inflammatory bowel disease, chronic constipation
- History of diarrhoea or emesis within the past 14 days of screening
- History of gastrointestinal surgery with exception of appendectomy
- History of chronic autoimmune disease incl. dermatitis requiring immunosuppressive treatment within the past two months of screening or any skin condition that induces photosensitivity
- History of chronic skin disease potentially influencing the results (in particular skin diseases associated with photosensitivity)
- History and/or family history of skin cancer, incl. but not limited to melanoma, basal cell carcinoma and squamous cell carcinoma.
- Known symptomatic allergies, including food allergies or intolerances and sun allergy
- Any clinically relevant laboratory abnormalities in screening test
- Alcohol, cigarette or drug abuse
- Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
- Presence of any condition that impacts compliance with the study procedures
- Any underlying clinical condition that, in the opinion of the investigator, would make it very unlikely for the participant to complete the study successfully
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first study product administration, or planned use during the study period
- Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, State of Vienna, 1090
About this study
Official title: Study to Assess the Photosensitizing Potential of Frequently Prescribed Medicines in Healthy Volunteers: a Pilot Study
This pilot trial aims to study 10 selected commonly prescribed medicines with different grade of phototoxic potential. As there is no currently established way to assess phototoxic potential in a systematic and quantitative way, we want to test a novel radiation and measurement protocol to provide more granular information for patients and providers.
Read the detailed description
The purpose of this clinical study is to test ten commonly prescribed drugs with known photosensitizing properties in order to gain more detailed knowledge about the effects, which can help to make recommendations for patients who need these drugs for their therapy. Phototoxic and photoallergic drug-induced reactions are relatively common side effects of multiple drugs. However, the incidence and threshold doses are underreported, misdiagnosed or not adequately investigated.
In this open, randomized, monocentric, parallel group study, 12 healthy subjects are randomized into 2 groups of 6 healthy subjects each after fulfilling inclusion and exclusion criteria and a screening visit (demographics, medical history, laboratory parameters, vital parameters, ECG, physical examination including skin examination and baseline measurement of skin properties). In the study, one drug from a fixed block of 5 drugs allocated during randomization is administered orally as a single dose weekly (on days 1, 8, 15, 22, 29). 6 hours after drug administration, when the drugs have reached their peak plasma concentrations, the skin is irradiated with UVA, UVB and visible light at previously determined locations on the upper and lower arms and back. The irradiation is carried out using equipment that is also used in clinical routine, namely a UVA lamp from Sellamed (Germany), UVB lamps from Waldmann Medizintechnik and a slide projector for visible light radiation. In the next step, skin reactions that occur immediately after irradiation and after 24 hours are analyzed using Mexameter®, Aquaflux® and a confocal Raman microscope. In addition to the safety blood parameters, regular reserve blood samples are taken at the screening and final visits for the purpose of possible later analysis of drug levels. The subjects are asked to avoid direct sunlight for the entire duration of the study or, if this cannot be avoided, to use a high sun protection factor. The final visit (visit 12) is planned for day 36.
- Conditions
- Phototoxicity
- Being tested
- Single oral dose of selected medicines, respectively, UVA and UVB radiation
- Keywords
- clinical pharmacology, phototoxicity, dermatology, adverse drug reactions
- Medical subject headings
- Dermatitis, Phototoxic, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single oral dose of selected medicines, respectivelyDrug
Also called group 1
amiodarone (Amiodaron Arcana) 200mg, diclofenac (Diclobene) 100mg, hydrochlorothiazide (HCT G.L) 25mg, pantoprazole (Pantoloc) 40mg, voriconazole (Voriconazol Aristo®) 200mg
UVA and UVB radiationRadiation
The skin of the inner arm will be exposed to five fixed incremental doses of UVA and UVB. Each dose will be applied to a circular area on the inner forearm of 1 cm diameter for both UVA and UVB.
Single oral dose of selected medicines, respectivelyDrug
Also called group 2
acetylsalicylic acid (ASS Genericon) 500mg, doxycycline (Doxybene) 200mg, enalapril (Enalapril "ratiopharm") 10mg, furosemide (Lasix) 40mg, verapamil (Verapabene) 80mg
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | single oral dose of following medications, including 7 days wash-out phase respectively:
1. diclofenac
2. voriconazole
3. hydrochlorothiazide
4. pantoprazole
5. amiodarone Receives: Drug: Single oral dose of selected medicines, respectively; Radiation: UVA and UVB radiation |
| Group 2 | Active comparator | single oral dose of following medications, including 7 days wash-out phase respectively:
1. acetylsalicylic acid
2. verapamil
3. doxycycline
4. furosemide
5. enalapril Receives: Radiation: UVA and UVB radiation; Drug: Single oral dose of selected medicines, respectively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal erythema dose
To assess the Minimal Erythema Dose (MED) of 10 selected human medicines with known photosensitizing properties for UVA and UVB and the reaction to visible spectrum light 24 hours after exposure to radiation
Measured: after 24 hours once weekly respectively, for 5 weeks in total
Secondary outcomes (3)
Transepidermal water loss
To assess the transepidermal water loss (TEWL) as a marker of skin barrier function of 10 selected medicines with known photosensitizing properties 24 hours after exposure to UVA, UVB and visible spectrum light radiation.
Measured: after 24 hours once weekly respectively, for 5 weeks in total
Change in molecular skin properties
To assess changes in skin properties on a molecular level of 10 selected medicines with known photosensitizing properties 24 hours after exposure to UVA, UVB and visible specrum light radiation
Measured: after 24 hours once weekly respectively, for 5 weeks in total
Immediate photosensitivity and phototoxicity reactions
To assess other immediate photosensitivity and phototoxicity reactions of 10 selected medicines with known photosensitizing properties after exposure to UVA, UVB and visible spectrum light radiation, including
- presence of exanthema
- presence of hyperpigmentation
- presence of erythema
- presence of urticaria
- presence of pruritus
- presence of combustion
Measured: Immediately after UV exposure once weekly, respectively, for 5 weeks in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start22 Sep 2022
- Primary completion9 Apr 2024
- Study completion3 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhototoxicityStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Wolzt, Prof. MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710600
- Sponsor's protocol ID
- Phototox
- Other IDs
- 2021-000467-80
- Acronym
- Phototox
- Status last verified
- Oct 2024
- First submitted
- 21 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Photosensitizing Potential of Frequently Prescribed Medicines in Healthy Volunteers: a Pilot Study
- ClinicalTrials.gov ID
- NCT06710600
- Acronym / sponsor ID
- Phototox / Phototox
- Conditions
- Phototoxicity
- Keywords
- clinical pharmacology, phototoxicity, dermatology, adverse drug reactions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 3 Oct 2024 (actual)
- First posted
- 29 Nov 2024 (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.
This pilot trial aims to study 10 selected commonly prescribed medicines with different grade of phototoxic potential. As there is no currently established way to assess phototoxic potential in a systematic and quantitative way, we want to test a novel radiation and measurement protocol to provide more granular information for patients and providers.
Detailed description
The purpose of this clinical study is to test ten commonly prescribed drugs with known photosensitizing properties in order to gain more detailed knowledge about the effects, which can help to make recommendations for patients who need these drugs for their therapy. Phototoxic and photoallergic drug-induced reactions are relatively common side effects of multiple drugs. However, the incidence and threshold doses are underreported, misdiagnosed or not adequately investigated.
In this open, randomized, monocentric, parallel group study, 12 healthy subjects are randomized into 2 groups of 6 healthy subjects each after fulfilling inclusion and exclusion criteria and a screening visit (demographics, medical history, laboratory parameters, vital parameters, ECG, physical examination including skin examination and baseline measurement of skin properties). In the study, one drug from a fixed block of 5 drugs allocated during randomization is administered orally as a single dose weekly (on days 1, 8, 15, 22, 29). 6 hours after drug administration, when the drugs have reached their peak plasma concentrations, the skin is irradiated with UVA, UVB and visible light at previously determined locations on the upper and lower arms and back. The irradiation is carried out using equipment that is also used in clinical routine, namely a UVA lamp from Sellamed (Germany), UVB lamps from Waldmann Medizintechnik and a slide projector for visible light radiation. In the next step, skin reactions that occur immediately after irradiation and after 24 hours are analyzed using Mexameter®, Aquaflux® and a confocal Raman microscope. In addition to the safety blood parameters, regular reserve blood samples are taken at the screening and final visits for the purpose of possible later analysis of drug levels. The subjects are asked to avoid direct sunlight for the entire duration of the study or, if this cannot be avoided, to use a high sun protection factor. The final visit (visit 12) is planned for day 36.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Single oral dose of selected medicines, respectively, Radiation: UVA and UVB radiationsingle oral dose of following medications, including 7 days wash-out phase respectively: 1. diclofenac 2. voriconazole 3. hydrochlorothiazide 4. pantoprazole 5. amiodarone |
| Group 2 | Active comparator | Radiation: UVA and UVB radiation, Drug: Single oral dose of selected medicines, respectivelysingle oral dose of following medications, including 7 days wash-out phase respectively: 1. acetylsalicylic acid 2. verapamil 3. doxycycline 4. furosemide 5. enalapril |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent
- Male or female 18-45 years of age (limits included)
- BMI 19-27 for males and BMI 17-25 for females
- Vital parameters at screening within normal limits
- Electrocardiogram without clinically significant pathologic abnormalities and with QTc values lesser than 450 ms
Key exclusion criteria (24 listed)
- Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test
- Lack of willingness or capacity to co-operate and comply with the study procedures appropriately
- Failure to perform screening or baseline examinations
- Regular use of any medication (prescription or over the counter) for prevention or treatment of any medical condition in the previous 2 months except intake of contraceptives
- Intake of any medication throughout the active phase of the study that would interfere with the study procedure as per investigator's judgement
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 |
|---|---|---|
| Single oral dose of selected medicines, respectivelyAlso: group 1amiodarone (Amiodaron Arcana) 200mg, diclofenac (Diclobene) 100mg, hydrochlorothiazide (HCT G.L) 25mg, pantoprazole (Pantoloc) 40mg, voriconazole (Voriconazol Aristo®) 200mg | Drug | Group 1 |
| UVA and UVB radiationThe skin of the inner arm will be exposed to five fixed incremental doses of UVA and UVB. Each dose will be applied to a circular area on the inner forearm of 1 cm diameter for both UVA and UVB. | Radiation | Group 1, Group 2 |
| Single oral dose of selected medicines, respectivelyAlso: group 2acetylsalicylic acid (ASS Genericon) 500mg, doxycycline (Doxybene) 200mg, enalapril (Enalapril "ratiopharm") 10mg, furosemide (Lasix) 40mg, verapamil (Verapabene) 80mg | Drug | Group 2 |
Primary outcome
Minimal erythema dose
Time frame: after 24 hours once weekly respectively, for 5 weeks in total
To assess the Minimal Erythema Dose (MED) of 10 selected human medicines with known photosensitizing properties for UVA and UVB and the reaction to visible spectrum light 24 hours after exposure to radiation
3 secondary outcomes
Transepidermal water loss
Time frame: after 24 hours once weekly respectively, for 5 weeks in total
Change in molecular skin properties
Time frame: after 24 hours once weekly respectively, for 5 weeks in total
Immediate photosensitivity and phototoxicity reactions
Time frame: Immediately after UV exposure once weekly, respectively, for 5 weeks in total
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 29 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Phototoxicity
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
RecruitingPhase 3
Phase IIb and III Safety and Efficacy Study Chlorin E6 Gel Photodynamic Therapy for Diabetic Foot Ulcers:
Diabetic Foot Ulcer (DFU)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single oral dose of selected medicines, respectively and UVA and UVB radiation in people with Phototoxicity, run by Medical University of Vienna at 1 site in Austria.
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 24 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 29 Nov 2024. 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 Austria. 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?
Minimal erythema dose (time frame: after 24 hours once weekly respectively, for 5 weeks in total). 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 29 Nov 2024.