Clinical Trial: The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized, Multicenter, Double Blind Study to Compare the Efficacy and Tolerability of Oleogel-S-10 for 3 Month Versus Placebo Only in Patients With Mild to Moderate Actinic Ker
Brief Summary: In this study the impact of Oleogel-S-10 versus placebo on actinic keratoses over a treatment period of 3 months will be tested. Additionally, once and twice daily applications are tested.
Detailed Summary: Oleogel-S-10 has shown efficacy and was well tolerated in two previous clinical trials. In the second open label phase II trial the efficacy of Oleogel-S-10 alone was similar compared to a more invasive treatment with cryotherapy. Response rates of 85% with a clear-ance of more than 75 % of the lesions of the patients treated with Oleogel-S-10 over three months were reported. These encouraging results led to the present randomized, multicenter, double blind phase II trial. The efficacy of the treatment shall be tested in a double blind placebo controlled (petroleum jelly) fashion in order to obtain more reliable results for the planning of a phase III study.
Sponsor: Birken AG
Current Primary Outcome: Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance. [ Time Frame: 18 weeks ]
Objective response of the marker actinic keratosis, defined as histologically complete or partial clearance (partial clearance = down-grading in Cockerell-classification). The marker actinic keratosis is defined as an initially selected lesion within the target area that will be used for final biopsy.
The Cockerell classification refers to a single lesion, graded as the presence of atypical cells in the lower third of the epidermis (grade I), involvement of at least the lower two-thirds (grade II) or atypical keratinocytic proliferation in the entire epidermis (grade III). Thus a down-grading from a higher Cockerell grade (e.g., III) to a lower Cockerell grade (e.g., I) represents a positive outcome and treatment success.
Original Primary Outcome: Clinical clearance of all treated actinic keratoses [ Time Frame: 18 weeks ]
Current Secondary Outcome:
Original Secondary Outcome: Histologically controlled complete clearance Histologically controlled downstaging 75 % clearance rate Dose response relationship Time to clinically complete response Tolerability [ Time Frame: 18 weeks ]
Information By: Amryt Pharma
Dates:
Date Received: November 5, 2008
Date Started: October 2008
Date Completion:
Last Updated: August 30, 2015
Last Verified: August 2015
