A study to compare the skin tissues exposure of GF-001001-00 2% cream.

• Research type

  Research Study

• Full title

  GF-001001-00: A single-centre, phase I, open label, parallel cohorts, multiple dose study to compare the skin tissues exposure of once versus twice a day topical applications of 2 % cream formulation.

• IRAS ID

  36968

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Ferrer Internacional Ltd

• Eudract number

  2009-016219-39

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The drug being tested in this study is code-named as GF-001001-00, which is a potentially useful new quinolone (an antibiotic) for the topical treatment of uncomplicated skin and skin structure infections. Quinolones have antibacterial activities and drugs from the Quinolone group have been on market for many years. GF-001001-00 2% cream has been tested previously in healthy male volunteers as multiple applications to the skin and was shown to be well tolerated. This study is to compare the amount of drug (GF-001001-00) that the skin is exposed to when the cream is applied once per day versus twice per day applications. The sponsor, Ferrer Internacional S.A will provide funding for this research. This is an open (both subjects and researchers will know which treatment is being received), parallel, multiple-dose, non-therapeutic study in a total of 24 healthy volunteers. The study will be run as 2 groups of 12 subjects. Group 1 will receive 1 dose per day of 0.2 g GF-001001-00 2% cream. Group 2 will receive 2 doses per day of 0.2 g GF-001001-00 2% cream. In both groups the cream will be applied to 3 different treatment areas on the upper back for 3 consecutive days.

• REC name

  Wales REC 2

• REC reference

  09/WSE02/53

• Date of REC Opinion

  13 Nov 2009

• REC opinion

  Favourable Opinion