Who is sponsoring NCT01345526?

NCT01345526 is sponsored by Universitätsmedizin Mannheim.

What drugs are being tested in NCT01345526?

Interventions in NCT01345526: Reconval K1 Cream, Reconval Cream.

What condition does NCT01345526 study?

NCT01345526 studies Metastatic Colorectal Cancer.

Is NCT01345526 still recruiting?

NCT01345526 is currently completed. Last updated 27 April 2021.

Last reviewed 2021-04-27 · How we verify

NCT01345526

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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.

Completed Phase 2 Last updated 27 April 2021

What this trial tests

Phase 2 trial testing Reconval K1 Cream in Metastatic Colorectal Cancer in 124 participants. Completed in 1 December 2016.

Timeline

1 April 2011

Primary endpoint
1 December 2016

1 December 2016

Quick facts

Lead sponsor	Universitätsmedizin Mannheim
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	124
Start date	1 April 2011
Primary completion	1 December 2016
Estimated completion	1 December 2016
Sites	2 locations across Germany, Slovenia

Drugs / interventions tested

Reconval K1 Cream
Reconval Cream — full drug profile →

Conditions studied

Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →

Sponsor

Universitätsmedizin Mannheim — full company profile →

Who can join

18 and older, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Occurrence of acne-like skin rash grade ≥ 2 (according to the CTCAE) version 4.02) during the 8 weeks of skin treatment.
Time frame: Week 8
PFS rate, toxicity, compliance
Time frame: Week 8

Sponsor's own 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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Skin problems and EGFR-tyrosine kinase inhibitor.
Kozuki T. · · 2016 · cited 90× · PMID 26826719 · DOI 10.1093/jjco/hyv207
Recommendations for the Prophylactic Management of Skin Reactions Induced by Epidermal Growth Factor Receptor Inhibitors in Patients With Solid Tumors.
Hofheinz RD, Deplanque G, Komatsu Y, Kobayashi Y, et al · · 2016 · cited 62× · PMID 27449521 · DOI 10.1634/theoncologist.2016-0051
A review of the treatment options for skin rash induced by EGFR-targeted therapies: Evidence from randomized clinical trials and a meta-analysis.
Ocvirk J, Heeger S, McCloud P, Hofheinz RD. · · 2013 · cited 41× · PMID 23801914 · DOI 10.2478/raon-2013-0014
Evaluation of EGFR inhibitor-mediated acneiform skin toxicity within the double-blind randomized EVITA trial: A thorough gender-specific analysis using the WoMo score.
Gaiser MR, Lorenzen S, Merx K, Trojan J, et al · · 2019 · cited 5× · PMID 31199595 · DOI 10.1002/cam4.2132

Verify or expand the search:

Other recruiting trials for Metastatic Colorectal Cancer

Currently open trials in the same condition.

NCT07416552 — A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC) · Phase 1 · recruiting
NCT07314294 — Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients · Phase 2 · recruiting
NCT06856837 — - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Misma · Phase 2 · recruiting
NCT06959550 — Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorect · Phase 2 · recruiting
NCT06808685 — Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie · recruiting

Other Universitätsmedizin Mannheim trials

Trials by the same sponsor.

NCT06416319 — Preoperative Physical Activity Improvement With the Use of Activity Trackers Before Radical Cystectomy (PreAct) · NA · recruiting
NCT04534998 — Robotic-assisted vs. Open Partial Nephrectomy · Phase 2 · unknown
NCT05575856 — Cardiogenic Shock Registry Mannheim · unknown
NCT04146701 — Metabolomics and Microbiomics in Cardiovascular Diseases · unknown
NCT04533633 — German Epicardial Collateral CTO Registry · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01345526 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universitätsmedizin Mannheim
Last refreshed: 27 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01345526.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing