All topical ketoprofen in Transfersome gel groups ( 25 mg , 50 mg and 100 mg ) had improvements in pain that were superior to all other treatment arms , and the 50 mg topical ketoprofen in Transfersome gel group had functional gains that were superior to all other treatment arms .
The majority of the adverse events were non-serious and related to skin and subcutaneous tissue disorders , with erythema being the most common .
Topical ketoprofen in Transfersome gel is an effective means of treating symptoms of knee OA , and is superior to oral celecoxib , oral placebo and topical placebo .
The most commonly reported adverse events associated with the use of topical ketoprofen in Transfersome gel were non-severe skin and subcutaneous tissue disorders .
Furthermore , as topical ketoprofen in Transfersome gel was associated with fewer adverse events when compared with oral celecoxib , and had rates of GI adverse events comparable with those of topical placebo , it may be ideal for those who are unable to take oral NSAIDs
PURPOSE Topical ketoprofen in Transfersome gel has been used for the alleviation of symptoms in osteoarthritis .
Non-steroidal anti-inflammatory drugs ( NSAIDs ) are associated with various side effects .
Topical NSAIDs are known to have a lower side-effect profile when compared with systemic administration .
The present systematic review aim ed to determine the safety and efficacy of topical ketoprofen in Transfersome gel in knee osteoarthritis ( OA ) .
A multicentre, randomized, placebo- and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with osteoarthritis.
OBJECTIVE To assess the efficacy and safety of 12-week treatment with ketoprofen in ultradeformable phospholipid vesicles in patients with OA knee pain and to compare the efficacy with that of ketoprofen-free vehicle and celecoxib . METHODS ; A multicentre , double-blind controlled study in which patients with knee OA and moderate pain were r and omized to one of the six arms : topical ketoprofen 50 or 100 mg in ultradeformable vesicles ( IDEA-033 ) , 2.2 or 4.4 g ketoprofen-free vehicle ( TDT 064 ) , oral celecoxib 100 mg or matching oral placebo , all bd . The primary outcome was change from baseline in the WOMAC pain subscale at week 12 . RESULTS A total of 1395 patients received treatment .  Baseline mean WOMAC pain scores ranged from 4.7 to 4.8 across groups . The mean reduction in WOMAC pain score at week 12 was -1.9 ( -40.8 % ) for ketoprofen 50 mg , -1.9 ( -40.9 % ) for ketoprofen 100 mg , -1.9 ( -39.8 % ) for 2.2 g TDT 064 , -1.8 ( -37.8 % ) for 4.4 g TDT 064 , -1.9 ( -40.4 % ) for celecoxib and -1.4 ( -29.3 % ) for oral placebo . IDEA-033 was not statistically superior to TDT 064 . All topical treatments were statistically superior to oral placebo and non-inferior to celecoxib . The most frequent types of treatment-related adverse events reported were gastrointestinal for oral ( 15.9 % for celecoxib ) and dermal for topical applications ( 12.2 % for ketoprofen 100 mg ) . CONCLUSION IDEA-033 was not superior to ketoprofen-free vehicle , but both formulations were superior to oral placebo and non-inferior to celecoxib in reducing OA knee pain . TRIAL REGISTRATION Clinical Trials.gov , http:// clinical trials.gov/ , NCT00716547
All topical ketoprofen in Transfersome gel groups ( 25 mg , 50 mg and 100 mg ) had improvements in pain that were superior to all other treatment arms , and the 50 mg topical ketoprofen in Transfersome gel group had functional gains that were superior to all other treatment arms .
The majority of the adverse events were non-serious and related to skin and subcutaneous tissue disorders , with erythema being the most common .
Topical ketoprofen in Transfersome gel is an effective means of treating symptoms of knee OA , and is superior to oral celecoxib , oral placebo and topical placebo .
The most commonly reported adverse events associated with the use of topical ketoprofen in Transfersome gel were non-severe skin and subcutaneous tissue disorders .
Furthermore , as topical ketoprofen in Transfersome gel was associated with fewer adverse events when compared with oral celecoxib , and had rates of GI adverse events comparable with those of topical placebo , it may be ideal for those who are unable to take oral NSAIDs
PURPOSE Topical ketoprofen in Transfersome gel has been used for the alleviation of symptoms in osteoarthritis .
Non-steroidal anti-inflammatory drugs ( NSAIDs ) are associated with various side effects .
Topical NSAIDs are known to have a lower side-effect profile when compared with systemic administration .
The present systematic review aim ed to determine the safety and efficacy of topical ketoprofen in Transfersome gel in knee osteoarthritis ( OA ) .