Safety Evaluation of TH-188 Cream

TH-188 cream is a topical medicament containing 3. 0% Ketoprofen. Ketoprofen is a nonsteroidal antiinflammatory agent and TH-188 cream was developed as an anodyne topical medicament for orthopedical diseases such as sprain or rheumarthritis. We performed open patch test, 20 minutes closed patch test, 24 hours closed patch test and photo patch test in 30 healthy adult volunteers and 24 patients with skin diseases. The readings of these patch tests were done according to Japanese Patch Test Research Group's recommendation. Inteban ointment� (Sumitomo Co., Ltd.) and Mobilat ointment� (Maruho Co., Ltd.) were taken as positive controls and white petrolatum. Sun White� (Nikko Rika Co., Ltd) was used as a negative control. In the open and closed tests with healthy volunteers and patients, TH-188 cream and TH-188 cream base showed lower positive rates than Inteban ointment and Mobilat ointment and no reactions by photo patch test. So we decided TH-188 cream is safe when applied on the intact skin.