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Study to Evaluate the Influence of Hydrochlorothiazide on Dermal Photosensitivity and DNA Stability - a Pilot Study (HCTox Study)

Primary Purpose

Photosensitivity

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Hydrochlorothiazide
Placebo
Sponsored by
Universität des Saarlandes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Photosensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. The subject is willing and able to participate and provides written informed consent;
  2. Healthy subjects with no concomitant medical conditions;
  3. Age ≥ 18 years;
  4. The subject is willing to take HCT 25 mg a day although not clinically indicated;
  5. The subject is willing to undergo controlled UV-exposition although not clinically indicated;
  6. Skin type I - IV.

Exclusion Criteria:

  1. History of any cardiac disease;
  2. History of any dermatologic disease;
  3. Renal insufficiency (eGFR <60 ml/min/1.73m²);
  4. Intake of photosensitive substances, especially intake of HCT;
  5. Frequent, above-average, UV exposition (naturally or artificially);
  6. Known hypertension;
  7. Known electrolyte disbalance;
  8. Systolic blood pressure at baseline <100 mmHg;
  9. Skin type V and VI;
  10. History of severe diseases, which could endanger the safety of study participant;
  11. Known unresolved history of alcohol dependency or drug abuse or any other kind of dependencies
  12. Intake of any of the following medications or substances: Betablockers; nitrates; barbiturates; phenothiazines; tricyclic antidepressants; vasodilatory drugs; ACE-inhibitors; NSAIDs; salicylates; phenytoin; Insulin; oral antidiabetic drugs; vasoconstrictors; glycosides; substances lowering blood-urea levels; substances causing a Long-QT-Syndrome; chinidine; carbamazepine; cyclosporine; cholecalciferol; potassium salts; amantadine; allopurinol; methyldopa; cholestyramine; colestipol; other diuretics; lithium; cytostatic drugs;
  13. Women in childbearing age and not using medically acceptable effective contraception refer to CTFG: The study population includes female of childbearing potential. Female of childbearing potential have to agree to comply with the applicable contraceptive requirements of the protocol for the duration of the study or having post-menopausal status or be permanently sterilized (at least 6 weeks post-sterilization). Highly effective contraception is defined as a contraceptive method with failure rate of less than 1 % per year when used consistently and correctly and when applicable, in accordance with the product label;
  14. Subject is pregnant (e.g., positive ß-hCG test) or is breast feeding;
  15. Hypersensitivity to the active substance, to HCT or any of its excipients.

Sites / Locations

  • Saarland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

Intake of HCT 25 mg, 1 tablet/d for 15 days

Intake of Placebo, 1 tablet/d for 15 days

Outcomes

Primary Outcome Measures

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.
Amount of excretion of pyrimidine-dimers (PD) in urine.
Changes from Baseline Visit to Day 26

Secondary Outcome Measures

Changes in blood-serum vitamin-D levels.
Changes from Baseline Visit to Day 24
Changes in blood pressure.
Changes from Baseline Visit to Day 24

Full Information

First Posted
November 24, 2020
Last Updated
November 18, 2021
Sponsor
Universität des Saarlandes
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1. Study Identification

Unique Protocol Identification Number
NCT04654312
Brief Title
Study to Evaluate the Influence of Hydrochlorothiazide on Dermal Photosensitivity and DNA Stability - a Pilot Study (HCTox Study)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
July 22, 2021 (Actual)
Study Completion Date
July 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universität des Saarlandes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photosensitivity

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
National, prospective, single-center, double-blind, parallel group, randomized, controlled, interventional Trial.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intake of HCT 25 mg, 1 tablet/d for 15 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intake of Placebo, 1 tablet/d for 15 days
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide
Other Intervention Name(s)
HCT
Intervention Description
Please see arm descriptions
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Please see arm descriptions
Primary Outcome Measure Information:
Title
Changes in subjects´ minimal-erythema-dose (MED).
Description
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
Title
Amount of excretion of pyrimidine-dimers (PD) in urine.
Description
Changes from Baseline Visit to Day 26
Time Frame
26 days
Secondary Outcome Measure Information:
Title
Changes in blood-serum vitamin-D levels.
Description
Changes from Baseline Visit to Day 24
Time Frame
26 days
Title
Changes in blood pressure.
Description
Changes from Baseline Visit to Day 24
Time Frame
26 days
Other Pre-specified Outcome Measures:
Title
Changes in electrolytes (Na+, K+)
Description
Changes from Baseline Visit to Day 24
Time Frame
26 days
Title
Changes in kidney function (eGFR)
Description
Changes from Baseline Visit to Day 24
Time Frame
26 days
Title
Changes in blood count
Description
Changes from Baseline Visit to Day 24
Time Frame
26 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The subject is willing and able to participate and provides written informed consent; Healthy subjects with no concomitant medical conditions; Age ≥ 18 years; The subject is willing to take HCT 25 mg a day although not clinically indicated; The subject is willing to undergo controlled UV-exposition although not clinically indicated; Skin type I - IV. Exclusion Criteria: History of any cardiac disease; History of any dermatologic disease; Renal insufficiency (eGFR <60 ml/min/1.73m²); Intake of photosensitive substances, especially intake of HCT; Frequent, above-average, UV exposition (naturally or artificially); Known hypertension; Known electrolyte disbalance; Systolic blood pressure at baseline <100 mmHg; Skin type V and VI; History of severe diseases, which could endanger the safety of study participant; Known unresolved history of alcohol dependency or drug abuse or any other kind of dependencies Intake of any of the following medications or substances: Betablockers; nitrates; barbiturates; phenothiazines; tricyclic antidepressants; vasodilatory drugs; ACE-inhibitors; NSAIDs; salicylates; phenytoin; Insulin; oral antidiabetic drugs; vasoconstrictors; glycosides; substances lowering blood-urea levels; substances causing a Long-QT-Syndrome; chinidine; carbamazepine; cyclosporine; cholecalciferol; potassium salts; amantadine; allopurinol; methyldopa; cholestyramine; colestipol; other diuretics; lithium; cytostatic drugs; Women in childbearing age and not using medically acceptable effective contraception refer to CTFG: The study population includes female of childbearing potential. Female of childbearing potential have to agree to comply with the applicable contraceptive requirements of the protocol for the duration of the study or having post-menopausal status or be permanently sterilized (at least 6 weeks post-sterilization). Highly effective contraception is defined as a contraceptive method with failure rate of less than 1 % per year when used consistently and correctly and when applicable, in accordance with the product label; Subject is pregnant (e.g., positive ß-hCG test) or is breast feeding; Hypersensitivity to the active substance, to HCT or any of its excipients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix Mahfoud, MD
Organizational Affiliation
Saarland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saarland University Hospital
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/DE/RHB/2018/rhb-hydrochlorothiazid.html
Description
Hydrochlorothiazid - Risiko von nichtmelanozytärem Hautkrebs [Basalzellkarzinom (Basaliom); Plattenepithelkarzinom der Haut (Spinaliom): Rote-Hand-Brief vom 17. Oktober 2018.

Learn more about this trial

Study to Evaluate the Influence of Hydrochlorothiazide on Dermal Photosensitivity and DNA Stability - a Pilot Study (HCTox Study)

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