PMID- 16574034 OWN - NLM STAT- MEDLINE DCOM- 20060810 LR - 20151119 IS - 0300-7995 (Print) IS - 0300-7995 (Linking) VI - 22 IP - 3 DP - 2006 Mar TI - A comparison of the skin irritation potential of transdermal fentanyl versus transdermal buprenorphine in middle-aged to elderly healthy volunteers. PG - 501-9 AB - OBJECTIVE: Establishing local tolerability of transdermal opioid systems is important as more systems become available for use in a range of indications. We compared the skin irritation potential of a single application of transdermal fentanyl (Durogesic D-trans; DDTDF) and transdermal buprenorphine (Transtec; TDB) patches in healthy volunteers. METHODS: 46 healthy males and females (mean age [range]: 59.6 [50-69] years) with healthy skin received a single dose of both the DDTDF 25 mug/h patch and the TDB 35 mug/h patch in a randomised order under naltrexone cover. The incidence and severity of erythema was assessed at various timepoints after patch removal. RESULTS: There was a non-significant trend towards a higher incidence of erythema 60 min after patch removal with TDB compared with DDTDF. The severity of erythema at 60 min and the incidence of erythema at 72 h after patch removal were significantly higher with TDB than with DDTDF (p = 0.01 and 22% versus 4.9%, p = 0.04, respectively). In general, the results from the chromametric assessment of treated skin were in agreement. The incidence of topical adverse events (AEs) was lower with DDTDF than with TDB (one versus six events) and subjects preferred the DDTDF patch and felt it was less noticeable on the skin. The DDTDF patch was considered less painful to remove, and, consistent with that, the TDB patch was judged to have better adhesion. Twenty-one subjects reported systemic AEs with DDTDF plus naltrexone and 22 with TDB plus naltrexone, most of which were considered treatment-related, 34 and 60 AEs, respectively. CONCLUSIONS: Local tolerability of transdermal opioid systems should be considered when making a therapeutic choice. Even after a single application in healthy volunteers, differences in local tolerability, assessed both clinically and by chromametry, and patch comfort were shown between DDTDF and TDB, in favour of DDTDF. FAU - Schmid-Grendelmeier, Peter AU - Schmid-Grendelmeier P AD - University Hospital of Zurich, Zurich, Switzerland. FAU - Pokorny, Rolf AU - Pokorny R FAU - Gasser, Urs E AU - Gasser UE FAU - Richarz, Ute AU - Richarz U LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Analgesics, Opioid) RN - 40D3SCR4GZ (Buprenorphine) RN - UF599785JZ (Fentanyl) SB - IM MH - Administration, Cutaneous MH - Aged MH - Analgesics, Opioid/administration & dosage/*adverse effects MH - Buprenorphine/administration & dosage/*adverse effects MH - Drug Delivery Systems MH - Erythema/*chemically induced MH - Female MH - Fentanyl/administration & dosage/*adverse effects MH - Humans MH - Male MH - Middle Aged MH - Skin/*drug effects MH - Statistics, Nonparametric MH - Surveys and Questionnaires EDAT- 2006/04/01 09:00 MHDA- 2006/08/11 09:00 CRDT- 2006/04/01 09:00 PHST- 2006/04/01 09:00 [pubmed] PHST- 2006/08/11 09:00 [medline] PHST- 2006/04/01 09:00 [entrez] AID - 10.1185/030079906X89829 [doi] PST - ppublish SO - Curr Med Res Opin. 2006 Mar;22(3):501-9. doi: 10.1185/030079906X89829.