CompletedPhase 1

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

Germany30 participantsStarted 2021-01-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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;

What they're measuring

Changes in subjects´ minimal-erythema-dose (MED).

Timeframe: 2 weeks

Amount of excretion of pyrimidine-dimers (PD) in urine.

Timeframe: 26 days

Trial details

NCT IDNCT04654312

SponsorUniversität des Saarlandes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-22

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