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The effect of topical vitamin K on skin rash

Comparative study of the effect of topical vitamin K with placebo in the treatment of skin rash in patients with metastatic colon cancer treated with Cetuximab

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150304021338N3
Enrollment
48
Registered
2021-09-20
Start date
2021-09-16
Completion date
Unknown
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin rash. Rash and other nonspecific skin eruption

Interventions

Intervention 1: Intervention group: Patients with skin rash has been induced by Cetuximab,will use topical 0.1% vitamin K cream, including a combination of vitamin K1 (Phytonadione) produced by Caspia

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with metastatic colorectal cancer that are candidates for treatment with Cetuximab . Patients with grade 1 to 4 skin lesions, after using Cetuximab(based on Common Terminology Criteria for Adverse Events4 (CTCAE4)) Be over 18 years old The patient should not undergo radiotherapy. Have a desire to participate in the study.

Exclusion criteria

Exclusion criteria: The patient has skin lesions before receiving cetuximab (including rash, acne, pustules, inflammatory erythema) Being pregnant or in breastfeeding duration Previous history of allergies to compounds containing vitamin K Has a psychiatric disorder that is not able to participate in the study For other reasons, he is taking drugs that have a drug interaction with topical vitamin K Be taking medicinal compounds containing vitamin K

Design outcomes

Primary

MeasureTime frame
Grade of skin lesions, based on Common Terminology Criteria for Adverse Events4 (CTCAE4). Timepoint: At the beginning of the study and 4 and 8 weeks after using topical vitamin K. Method of measurement: Based on CTCEA4.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahmoud Rezaei

Esfahan University of Medical Sciences

dralirezarezaei1991@gmail.com+98 31 3235 0214

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026