Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04654312
Status:
COMPLETED
Last Update Posted:
2021-11-19
First Post:
2020-11-24
Brief Title:
Study to Evaluate the Influence of Hydrochlorothiazide on Dermal Photosensitivity and DNA Stability - a Pilot Study HCTox Study
Sponsor:
Universität des Saarlandes
Organization:
Universität des Saarlandes
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study to Evaluate the Influence of Hydrochlorothiazide on Dermal Photosensitivity and DNA Stability - a Pilot Study HCTox Study
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None