Trials / Completed
CompletedNCT01345526
Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream
A Double Blind Placebo Controlled Randomized Phase II Study Evaluating the Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream in First Line mCRC Patients Treated With Erbitux and FOLFIRI.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 124 (actual)
- Sponsor
- Universitätsmedizin Mannheim · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this Phase 2, two-arm, randomized, double blind placebo controlled study is to evaluate the efficacy of combination therapy of doxycycline and Vitamin K1 compared to doxycycline plus placebo for the prevention of acne-like skin rash in mCRC patients receiving first line cetuximab treatment.
Detailed description
The aim of this Phase 2, two-arm, randomized, double blind placebo controlled study is to evaluate the efficacy of combination therapy of doxycycline and Vitamin K1 compared to doxycycline plus placebo for the prevention of acne-like skin rash in mCRC patients receiving first line cetuximab treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Reconval K1 Cream | |
| DEVICE | Reconval Cream |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2011-05-02
- Last updated
- 2021-04-30
Locations
2 sites across 2 countries: Germany, Slovenia
Source: ClinicalTrials.gov record NCT01345526. Inclusion in this directory is not an endorsement.