The clinical trial is designed as a national, prospective, single-center, double-blind, parallel group, randomized, controlled, interventional trial to investigate whether a therapy with HCT compared with placebo can affect dermal photosensitivity and DNA stability.
Previously published retrospective analyses leading to the official warning about the use of hydrochlorothiazide (HCT). The underlying pilot study examins, if the intake of HCT leads to increased dermal photosensitivity and in combination with UV-exposition to a DNA-damage of the skin. Up until today, there is no prospective, randomized, placebo-controlled trial investigating the impact of HCT on dermal photosensitivity in greater detail. The pilot trial is designed as feasibility study to clarify the impact of HCT on dermal photosensitivity. This may facilitate evidence-based recommendations as to whether or not HCT increases the risk for skin cancer. Of note, HCT is one of most frequently prescribed drugs in Germany.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
30
Please see arm descriptions
Please see arm descriptions
Saarland University Hospital
Homburg, Saarland, Germany
Changes in subjects´ minimal-erythema-dose (MED).
The MED is the minimal erythema dose, meaning the minimal dose of energy (in this case provided by UV-exposition) per area that leads to a clinically visible skin reaction, mainly a slight reddening. The MED is assessed by a clinical tool called the light-stair.
Time frame: 2 weeks
Amount of excretion of pyrimidine-dimers (PD) in urine.
Changes from Baseline Visit to Day 26
Time frame: 26 days
Changes in blood-serum vitamin-D levels.
Changes from Baseline Visit to Day 24
Time frame: 26 days
Changes in blood pressure.
Changes from Baseline Visit to Day 24
Time frame: 26 days
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