A study to investigate the Local Tolerability of topical DGLA.

• Research type

  Research Study

• Full title

  A Randomised, Double-blind, Placebo-controlled, Multiple Ascending-dose Study to Investigate the Local Tolerability of Topical Dihomo-gamma-linolenic Acid (DGLA)

• IRAS ID

  107644

• Contact name

  Simon L Singer

• Sponsor organisation

  Dignity Sciences Limited

• Eudract number

  2012-002037-10

• ISRCTN Number

  N/A

• Research summary

  This study has been designed to investigate the tolerability of a medicated cream as well as how the body absorbs and processes the drug (pharmacokinetics) when administered twice daily for 14 days in healthy volunteers. The assessments of tolerability will be performed using a dermal scoring system. The study will take place at ICON Development Solutions Clinical Pharmacology Unit in Manchester. Approximately 30 healthy male and female volunteers, aged 18 to 45 years inclusive, will participate in the study in five groups (cohorts) of six (3 females and 3 males). Subjects in each cohort will be randomised 5:1 to receive either active drug on one forearm and placebo (dummy drug) on the other forearm, or placebo on both forearms. The doses will be escalated for each cohort. Volunteers are expected to complete a screening visit and twice daily for a 14 days treatment period as well as a follow-up visit 7-10 days after last dose of the drug has been received. Volunteers will receive approximately 0.3 g of cream twice a day for 14 days. Neither the clinical staff nor the volunteers will know whether they received active drug or dummy drug (placebo). Order in which the volunteers receive active drug and or placebo will not be known.

• REC name

  North East - York Research Ethics Committee

• REC reference

  12/NE/0224

• Date of REC Opinion

  5 Jul 2012

• REC opinion

  Further Information Favourable Opinion