Effectiveness of Eczacin Skin Repair Cream on Time to Onset of Radiation-Induced Skin Injury

Clinical Evaluation of the Effectiveness of Eczacin Skin Repair Cream on the Time to Onset of Radiodermatitis in Breast Cancer Patients Undergoing Breast-Conserving Surgery: A Double-Blind Randomized Clinical Trial Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20241018063405N2

Enrollment

112

Registered

2026-04-03

Start date

2026-02-16

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Radiation-induced skin dermatitis. Disorder of the skin and subcutaneous tissue related to radiation, unspecified

Interventions

Intervention 1: Intervention group: Eczacin skin repair cream is a specialized topical product from Pharmed Salamat Sina Company, formulated to promote skin regeneration and healing. This cream contai

Eligibility

Sex/Gender

Female

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Written informed consent to participate in the study Diagnosed with breast cancer and prescribed radiotherapy Age between 18 and 75 years No prior history of radiotherapy

Exclusion criteria

Exclusion criteria: Breast cancer patients who have undergone mastectomy Pregnancy Presence of pre-existing or active skin diseases Incomplete radiotherapy treatment course History of radiotherapy to the thoracic region

Design outcomes

Primary

Measure	Time frame
Clinical evaluation of the effectiveness of Eczacin skin repair cream on the mean time to onset of radiation-induced skin reactions in breast cancer patients undergoing breast-conserving surgery. Timepoint: Once weekly during the course of radiotherapy, and at two weeks and four months after completion of treatment. Method of measurement: Using the validated CTCAE v5.0 scale and comparison with the contralateral breast skin color.	—

Measure

Time frame

Clinical evaluation of the effectiveness of Eczacin skin repair cream on the mean time to onset of radiation-induced skin reactions in breast cancer patients undergoing breast-conserving surgery. Timepoint: Once weekly during the course of radiotherapy, and at two weeks and four months after completion of treatment. Method of measurement: Using the validated CTCAE v5.0 scale and comparison with the contralateral breast skin color.

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Secondary

Measure	Time frame
Evaluation of the association between the effectiveness of the skin repair cream and the incidence of radiation-induced dermatitis in breast cancer patients undergoing breast-conserving surgery. Timepoint: Once weekly during the course of treatment, and at two weeks and four months after completion of radiotherapy. Method of measurement: CTCAE v5.0 scale.;Evaluation of the association between the effectiveness of the skin repair cream and the severity (grade) of radiation-induced dermatitis in breast cancer patients undergoing breast-conserving surgery. Timepoint: Once weekly during the course of treatment, and at two weeks and four months after completion of radiotherapy. Method of measurement: CTCAE v5.0 scale.;Evaluation of the association between the effectiveness of the skin repair cream and quality of life in breast cancer patients undergoing breast-conserving surgery. Timepoint: At the initiation of radiotherapy, at the completion of radiotherapy, and four months after completion of radiotherapy. Method of measurement: Validated EORTC QLQ-BR23 questionnaire.	—

Measure

Time frame

Evaluation of the association between the effectiveness of the skin repair cream and the incidence of radiation-induced dermatitis in breast cancer patients undergoing breast-conserving surgery. Timepoint: Once weekly during the course of treatment, and at two weeks and four months after completion of radiotherapy. Method of measurement: CTCAE v5.0 scale.;Evaluation of the association between the effectiveness of the skin repair cream and the severity (grade) of radiation-induced dermatitis in breast cancer patients undergoing breast-conserving surgery. Timepoint: Once weekly during the course of treatment, and at two weeks and four months after completion of radiotherapy. Method of measurement: CTCAE v5.0 scale.;Evaluation of the association between the effectiveness of the skin repair cream and quality of life in breast cancer patients undergoing breast-conserving surgery. Timepoint: At the initiation of radiotherapy, at the completion of radiotherapy, and four months after completion of radiotherapy. Method of measurement: Validated EORTC QLQ-BR23 questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Danial Fazilat-Panah

Babol University of Medical Sciences

drfazilatpanah@gmail.com+98 11 3527 1791

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026