Phototoxicity of Frequently Prescribed Medicines

NCT06710600 | Completed DMC

• 2 other identifiers: Phototox2021-000467-80
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 information for patients and providers.

Conditions

Phototoxicity

Keywords

clinical pharmacology; phototoxicity; dermatology; adverse drug reactions

Outcome Measures

Primary Outcomes (1)

• 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

  after 24 hours once weekly respectively, for 5 weeks in total

Secondary Outcomes (3)

• Transepidermal water loss

  after 24 hours once weekly respectively, for 5 weeks in total

• Change in molecular skin properties

  after 24 hours once weekly respectively, for 5 weeks in total

• Immediate photosensitivity and phototoxicity reactions

  Immediately after UV exposure once weekly, respectively, for 5 weeks in total

Study Arms (2)

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

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

Radiation: UVA and UVB radiation; Drug: Single oral dose of selected medicines, respectively

Interventions

Single oral dose of selected medicines, respectively DRUG

amiodarone (Amiodaron Arcana) 200mg, diclofenac (Diclobene) 100mg, hydrochlorothiazide (HCT G.L) 25mg, pantoprazole (Pantoloc) 40mg, voriconazole (Voriconazol Aristo®) 200mg

Also known as: group 1

Group 1

UVA and UVB radiation RADIATION

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.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Dermatitis, Phototoxic; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Photosensitivity Disorders; Skin Diseases, Eczematous; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 29, 2024
• Study Start: September 22, 2022
• Primary Completion: April 9, 2024
• Study Completion: October 3, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)