Comparing topical Lactokine containing gel with urea cream for prevention and treatment of skin reactions caused by radiotherapy of head and neck cancers.

Comparing topical Lactokine (TM) containing gel with urea cream for prevention and treatment of acute skin complications caused by radiotherapy of carcinoma of the head and neck.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017030632913N1

Enrollment

Registered

2017-05-04

Start date

2017-04-15

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Non-lynphoid cancers of head and neck region. Malignant neoplasms of lip, oral cavity and pharynx, Malignant neoplasm of nasal cavity and middle ear,Malignant neoplasm of accessory sinuses, Malignant neoplasm of larynx

Interventions

Intervention 1: Intervention group 1: Patients will use topical Urea containing cream with formulation of Urea 10%, Eucerin, Hydratant 400%, viit B6, Vit C for an area of skin of their radiotherapy f

Treatment - Other

Intervention group 1: Patients will use topical Urea containing cream with formulation of Urea 10%, Eucerin, Hydratant 400%, viit B6, Vit C for an area of skin of their radiotherapy field. According

Intervention group 2: Patients will use topical lactokine containing gel (R1), and hydrating cream (R2) according to the instructions. R1 should be used within 20 minutes after receiving radiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Cancer of the head and neck region; Proven histology of non-lymphomatoid cancers, Cases receiving at least 60 Gy to target volume; cases at least 18 years old; No active connective tissue disease exclusion criteria: receiving concurrent target therapy drugs (e.g. cetuximab); previous radiotherapy of head and neck

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Incidence and degree of radiodermititis. Timepoint: Visits from the first to the last day of radiotherapy, at least weekly. Method of measurement: CTCAE V.3 radiodermititis grading.	—

Secondary

Measure	Time frame
Subjective skin complications. Timepoint: during radiotherapy treatment. Method of measurement: visual metric mesure (0-10) of itching and burning sensation.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Aida Cheraghi

Firoozgar Clinical Research Development Center (FCRDC)

aidacheraghi@yahoo.com+98 21 8214 1795

Outcome results

None listed

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