Clinical trial · Interventional
A Study to Examine the Effect of Reconval K1 Cream to Prevent Skin Toxicity From EGFRI
A Phase II Randomized, Double Blind, Placebo Study to Evaluate the Efficacy of Vitamin K1 Cream Treatment Compared to Placebo for the Prevention of Papulo-pustular Rash in Metastatic Colorectal Patients Receiving First Line EGFRI Treatment.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Vitamin K1 cream may prevent papulopustular rash induced by EGFRI given to metastatic colorectal cancer patients. This study will prospectively accrue metastatic colorectal patients receiving EGFRI and treat with reconval cream half face versus placebo cream half face to study whether Vitamin k1 cream can prevent the typical skin eruption caused by EGFRI.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rash Due to Epidermal Growth Factor Receptor Inhibitors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PLACEBO | Drug | — | UNRESOLVED |
| RECONVAL CREAM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RECONVAL CREAM
- description
- half face treated with RECONVAL CREAM
- interventionNames
- Drug: RECONVAL CREAM
- type
- PLACEBO_COMPARATOR
- label
- PLACEBO
- description
- half face treated with PLACEBO cream
- interventionNames
- Drug: PLACEBO
Primary outcomes (1)
- measure
- Potential reduction in skin toxicity by Vitamin K1 cream in metastatic colorectal patients treated with EGFRI
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * metastatic colon cancer patients * male or female * age\> 18 * treated EGFRI Exclusion Criteria: * prior treatment with EGFRI
References
Publications (0)
Data not yet available