A comparison of the photosensitizing potential of trovafloxacin with that of other quinolones in healthy subjects

Abstract

Treatment with some quinolones is associated with an abnormal skin reaction following exposure to sunlight (photosensitivity). The objective of the current study was to compare the photosensitizing potential of a new quinolone, trovafloxacin, with that of ciprofloxacin, lomefloxacin and placebo. Forty-eight healthy males (age range 19-45 years) were randomized to receive a 7 day course of treatment with: (i) trovafloxacin 200 mg od; (ii) ciprofloxacin 500 mg bd; (iii) lomefloxacin 400 mg od; or (iv) placebo bd. Minimal erythema doses (MEDs) were assessed using a monochromator at baseline and on day 5 of treatment, for wavelengths of 305 +/- 5, 335 +/- 30, 365 +/- 30, 400 +/- 30 and 430 +/- 30 nm; 335 +/- 30 and 365 +/- 30 nm are within the UVA range. Immediate reaction MEDs were similar in all treatment groups. However, between baseline and day 5, the mean decreases in delayed-reaction MED (24 h) at 335 +/- 30 nm were only 18.99% for trovafloxacin versus placebo (P = 0.1267), compared with 53.77% (P 0.0001) and 64.13% (P 0.0001) for ciprofloxacin and lomefloxacin, respectively. Similarly, at 365 +/- 30 nm, trovafloxacin produced the smallest reduction in delayed MED versus placebo (43.66%), compared with ciprofloxacin (61.53%) and lomefloxacin (75.81%). These differences between trovafloxacin and ciprofloxacin and lomefloxacin were significant at both 335 +/- 30 and 365 +/- 30 nm (P 0.029). All MED values returned to baseline levels within 2 days of drug cessation. These results show that trovafloxacin has significantly less photosensitizing potential than either ciprofloxacin or lomefloxacin. This photosensitivity appears to be induced only by wavelengths in the UVA region, is maximal at 24 h and is a short-term effect.

A randomized controlled trial (volunteer study) of sitafloxacin, enoxacin, levofloxacin and sparfloxacin phototoxicity

“…Study methodology for the investigation has centred on Caucasian volunteers 5–7 using a positive and negative controlled, assessor‐blinded phototest technique comparing the threshold erythema results of phototesting prior to taking the drug/placebo with later on‐drug/placebo values. With the presented methodology, phototesting is conducted using a monochromator with wavebands representing the terrestrial solar spectrum spanning UVB and UVA into the visible region (290–430 nm) with additional testing using a solar simulator instrument.…”

“…None of the drugs under investigation in this study (Fig. 1) have been previously assessed using the described controlled monochromator and solar simulator technique 5–7 . Sitafloxacin (DU‐6859A) is a new FQ antibacterial agent under development by Daiichi Pharmaceuticals Co. Ltd (Tokyo, Japan).…”

“…Monochromator and solar simulator testing. Briefly, our standardized controlled monochromator and solar simulator phototesting technique, as previously described, 5–7,29 was used at baseline and ‘on‐drug’ on days 5 and 6 with immediate readings and 24/48 h delayed readings to determine the MED at each waveband tested. Pre‐drug testing was conducted on the right mid upper back skin avoiding the paravertebral area.…”

Eradication of early Pseudomonas infection in cystic fibrosis

“…62,66,67 Subjects taking oral ciprofloxacin should be warned regarding photosensitivity and advised to minimize exposure to strong sunlight by keeping covered and using sun-block as appropriate. 68 Nebulized antibiotics can cause bronchospasm, and an initial supervised test dose is recommended with pre and post clinical assessments and/or lung function. [69][70][71] In subjects in whom bronchospasm occurs pre-dosing with an inhaled bronchodilator may allow the nebulized antibiotic to be tolerated.…”

A Drug-Related Phototoxic Reaction and Its Possible Relationship to a Radiation-Induced Skin Reaction

“…In the modern medical era, antineoplastic cytotoxic agents such as actinomycin C and doxorubicin were some of the first drugs to be recognized as a cause of such reactions [3,4]. Apart from antineoplastic cytotoxic agents, other medications, particularly the class of antibiotics known as fluoroquinolones, have increasingly been shown to exhibit such untoward dermatologic side effects [5,6].…”