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

Photosensitivity Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04654312
• Other study ID #: HCTox
• Status: Completed
• Phase: Phase 1
• Start date: January 18, 2021
• Est. completion date: July 22, 2021

Study information

• Verified date: July 2021
• Source: Universität des Saarlandes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 22, 2021
• Est. primary completion date: July 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Photosensitivity
• Photosensitivity Disorders

Intervention

Drug:
• Hydrochlorothiazide
Please see arm descriptions
• Placebo
Please see arm descriptions

Locations

Country	Name	City	State
Germany	Saarland University Hospital	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
Universität des Saarlandes

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in electrolytes (Na+, K+)	Changes from Baseline Visit to Day 24	26 days
Other	Changes in kidney function (eGFR)	Changes from Baseline Visit to Day 24	26 days
Other	Changes in blood count	Changes from Baseline Visit to Day 24	26 days
Primary	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.	2 weeks
Primary	Amount of excretion of pyrimidine-dimers (PD) in urine.	Changes from Baseline Visit to Day 26	26 days
Secondary	Changes in blood-serum vitamin-D levels.	Changes from Baseline Visit to Day 24	26 days
Secondary	Changes in blood pressure.	Changes from Baseline Visit to Day 24	26 days

External Links

•   Hydrochlorothiazid - Risiko von nichtmelanozyta¨rem Hautkrebs [Basalzellkarzinom (Basaliom); Plattenepithelkarzinom der Haut (Spinaliom): Rote-Hand-Brief vom 17. Oktober 2018.