Efficacy and safety of epicutaneous ketoprofen in Transfersome (IDEA-033) versus oral celecoxib and placebo in osteoarthritis of the knee: multicentre randomised controlled trial

Rother, M.; Lavins, Bernhard J; Kneer, W.; Lehnhardt, Klaus; Seidel, E.; Mazgareanu, Stefan

doi:10.1136/ard.2006.065128

Cited by 101 publications

(70 citation statements)

References 18 publications

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“…The excipients of TDT 067 are widely used in pharmaceutical and cosmetic products for topical application, and clinical studies involving more than 2,000 patients with different diseases have shown that Transfersome preparations are well tolerated (2,16,22). Furthermore, in two phase II clinical studies of TDT 067 in patients with onychomycosis, treatment was well tolerated, and most patients did not experience application site reactions (6,27).…”

mentioning

confidence: 99%

Evaluation of the Morphological Effects of TDT 067 (Terbinafine in Transfersome) and Conventional Terbinafine on Dermatophyte Hyphae In Vitro and In Vivo

Ghannoum

Isham

Henry

et al. 2012

Antimicrob Agents Chemother

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TDT 067 is a novel, carrier-based dosage form of terbinafine in Transfersome (1.5%) formulated for topical delivery of terbinafine to the nail, nail bed, and surrounding tissue. We examined the effects of TDT 067 and conventional terbinafine on the morphology of dermatophytes. Trichophyton rubrum hyphae were exposed to TDT 067 or terbinafine (15 mg/ml) and examined under white light, scanning electron microscopy (SEM), and transmission electron microscopy (TEM). Subungual debris from patients treated with TDT 067 in a clinical trial was also examined. Exposure of T. rubrum hyphae to TDT 067 led to rapid and extensive ultrastructural changes. Hyphal distortion was evident as early as 4 h after exposure to TDT 067. After 24 h, there was complete disruption of hyphal structure with few intact hyphae remaining. Exposure to terbinafine resulted in morphological alterations similar to those seen with TDT 067; however, the effects of TDT 067 were more extensive, whereas a portion of hyphae remained intact after 24 h of exposure to terbinafine. Lipid droplets were observed under TEM following 30 min of exposure to TDT 067, which after 24 h had filled the intracellular space. These effects were confirmed in vivo in subungual debris from patients with onychomycosis who received topical treatment with TDT 067. The Transfersome in TDT 067 may potentiate the action of terbinafine by delivering terbinafine more effectively to its site of action inside the fungus. Our in vivo data confirm that TDT 067 can enter fungus in the nail bed of patients with onychomycosis and exert its antifungal effects.

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mentioning

confidence: 99%

Evaluation of the Morphological Effects of TDT 067 (Terbinafine in Transfersome) and Conventional Terbinafine on Dermatophyte Hyphae In Vitro and In Vivo

Ghannoum

Isham

Henry

et al. 2012

Antimicrob Agents Chemother

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“…In study CL-033-II-03, pain relief was reported with both IDEA-033 and TDT 064, but superiority of IDEA-033 to TDT 064 in improving physical function was not shown [7]. Marked clinical improvements in pain were also reported in study CL-033-III-02 with both IDEA-033 and TDT 064; pain relief was greater with IDEA-033 than TDT 064, but not improvements in physical function [10].…”

Section: Discussionmentioning

confidence: 51%

Meta-Analysis of Randomized Clinical Trials Investigating the Effect of TDT 064, a Gel-Based Formulation Containing Ultra-Deformable Phospholipid Vesicles, in Patients with Knee Osteoarthritis

Rother¹,

Vester²,

Bolten³

et al. 2014

Rheumatol Curr Res

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“…Topical formulations of ultradeformable phospholipid vesicles containing ketoprofen have been shown to be effective. 29 …”

Section: Nonsteroidal Anti-inflammatory Drugsmentioning

confidence: 97%

Managing the Pain of Knee Osteoarthritis

Hrnack¹,

Barber

2014

The Physician and Sportsmedicine

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Pain from knee osteoarthritis creates a significant burden for symptomatic patients, who are often forced to change their lifestyle because of their symptoms. Activity modification, therapy, weight loss, nonsteroidal anti-inflammatory drugs, shoe orthotics, bracing, and injections are the nonoperative options available. New technologies are also emerging in the treatment of knee osteoarthritis. Ultimately, these therapeutic modalities should reduce pain and increase the overall functioning of patients. These nonoperative modalities give the clinician several effective options before surgical management is considered.

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Efficacy and safety of epicutaneous ketoprofen in Transfersome (IDEA-033) versus oral celecoxib and placebo in osteoarthritis of the knee: multicentre randomised controlled trial

Cited by 101 publications

References 18 publications

Evaluation of the Morphological Effects of TDT 067 (Terbinafine in Transfersome) and Conventional Terbinafine on Dermatophyte Hyphae In Vitro and In Vivo

Evaluation of the Morphological Effects of TDT 067 (Terbinafine in Transfersome) and Conventional Terbinafine on Dermatophyte Hyphae In Vitro and In Vivo

Meta-Analysis of Randomized Clinical Trials Investigating the Effect of TDT 064, a Gel-Based Formulation Containing Ultra-Deformable Phospholipid Vesicles, in Patients with Knee Osteoarthritis

Managing the Pain of Knee Osteoarthritis

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