NCT00786994

The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses

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 Keratoses Located at the Face and Head Oleogel-S-10 in Actinic Keratoses Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Birken AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
DRUG	Oleogel-S10 100 mg/g	topical use once or twice daily
DRUG	Placebo (petroleum jelly)	topical use once or twice daily

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2008-11-06
• Last updated: 2015-09-14
• Results posted: 2015-08-14

Locations

6 sites across 2 countries: Germany, Greece