Lack of photosensitising potential of tenidap, a novel anti-rheumatic agent.
1. The potential of orally administered tenidap sodium, a novel anti-rheumatic agent under investigation for the treatment of rheumatoid arthritis and osteoarthritis, to cause phototoxic reactions was investigated. 2. Twenty-four healthy volunteers entered a randomised, double-blind study in which they received tenidap sodium 40 mg or 120 mg or placebo daily for 7 days. The minimal erythema dose was determined using wavelengths of 305-460 nm for 3 days prior to drug administration and on the last 3 days of dosing. Appropriate clinical and laboratory tests were performed before, during and after the dosing period. 3. Tenidap did not have a statistically significant effect on immediate or delayed photosensitivity. No drug-related side effects were reported and there were no clinically significant adverse findings from the laboratory tests. 4. At the dosage and duration of tenidap sodium used, a photosensitising potential has not been demonstrated.
Ferguson
J
J
Department of Dermatology, Ninewells Hospital, Dundee, UK.
Leeming
M R
MR
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D017484:Dermatitis, Phototoxic / Q000209:etiology*; D004311:Double-Blind Method; D004890:Erythema / Q000139:chemically induced; D005260:Female; D006801:Humans; D007211:Indoles / Q000009:adverse effects*; D008297:Male; D000078183:Oxindoles; D017319:Photosensitizing Agents / Q000009:adverse effects*; D012867:Skin / Q000187:drug effects*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007211:Indoles; D000078183:Oxindoles; D017319:Photosensitizing Agents; C062866:tenidap