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IRCT201206099979N1 IRCT 2013-03-09 Vice chancellor for research,, Shiraz University of Medical Sciences Alpha ointment (Henna) and hydrocortisone in radiation-induced dermatitis The efficacy and safety of topical Alpha ointment (containing natural Henna) compared to topical hydrocortisone 1% on healing of radiation-induced dermatitis in breast cancer patients 2012-01-01 anticipated 60 Complete https://irct.ir/trial/10485 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 severity of radiation - induced skin reaction. Intervention 1: Study group: Just before starting intervention, the patients were examined carefully; and patients’ data including age, stage, area of dermatitis grade 2 and 3, and severity of patients’ complaints were recorded. The area of dermatitis grade 2 and 3, and severity of patients’ complaints then was evaluated and registered weekly.In control group, topical Alpha ointment (produced by Alpha Development Company) was used with daily washing the chest wall area. Detailed instructions on topical Alpha were given to each patient as follows. Patients were instructed to apply a thin (1 millimeter) layer of the topical Alpha two times a day over chest wall field and to wash daily dermatitis area with water and mild soap. Treatment was started from the day of the last session of radiotherapy and continuing every day for 3 weeks. Each patient was examined weekly for 4 weeks. Intervention 2: Control group Just before starting intervention, the patients were examined carefully; and patients’ data including age, stage, area of dermatitis grade 2 and 3, and severity of patients’ complaints were recorded. The area of dermatitis grade 2 and 3, and severity of patients’ complaints then was evaluated and registered weekly.In control group, topical hydrocortisone 1% cream was used with daily washing the chest wall area. Detailed instructions on topical hydrocortisone 1% were given to each patient as follows. Patients were instructed to apply a thin (1 millimeter) layer of the topical hydrocortisone 1% two times a day over chest wall field and to wash daily dermatitis area with water and mild soap. Treatment was started from the day of the last session of radiotherapy and continuing every day for 3 weeks. Each patient was examined weekly for 4 weeks.
public Mohammad Mohammadianpanah
Namazi Hospital
Shiraz Iran (Islamic Republic of) +98 71 1612 5168 mohpanah@gmail.com Shiraz University of Medical Sciences scientific Mohammad Mohammadianpanah
Namazi Hospital
Shiraz Iran (Islamic Republic of) +98 71 1612 5168 mohpanah@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Eligible patients had to have newly pathologically proven diagnosed locally advanced breast cancer treated with modified radical mastectomy followed by sequential adjuvant chemotherapy and chest wall radiotherapy (45-50.4 Gy), and developed grade 2 and/or 3 radiation-induced dermatitis. Exclusion criteria: 1. Any history of collagen vascular diseases, or diabetes mellitus, 2. Taking any drugs interacting wound healing process, like systemic steroids, 3. Previous history of chest wall radiotherapy and 4. Concurrent use of chemotherapy. All patients had to sign a consent form approved by the local research ethics committee before participating in the study. 20 years 90 years Female L58.0, L58 Radiodermatitis Treatment - Drugs Treatment - Drugs Study group: Just before starting intervention, the patients were examined carefully; and patients’ data including age, stage, area of dermatitis grade 2 and 3, and severity of patients’ complaints were recorded. The area of dermatitis grade 2 and 3, and severity of patients’ complaints then was evaluated and registered weekly.In control group, topical Alpha ointment (produced by Alpha Development Company) was used with daily washing the chest wall area. Detailed instructions on topical Alpha were given to each patient as follows. Patients were instructed to apply a thin (1 millimeter) layer of the topical Alpha two times a day over chest wall field and to wash daily dermatitis area with water and mild soap. Treatment was started from the day of the last session of radiotherapy and continuing every day for 3 weeks. Each patient was examined weekly for 4 weeks. Control group Just before starting intervention, the patients were examined carefully; and patients’ data including age, stage, area of dermatitis grade 2 and 3, and severity of patients’ complaints were recorded. The area of dermatitis grade 2 and 3, and severity of patients’ complaints then was evaluated and registered weekly.In control group, topical hydrocortisone 1% cream was used with daily washing the chest wall area. Detailed instructions on topical hydrocortisone 1% were given to each patient as follows. Patients were instructed to apply a thin (1 millimeter) layer of the topical hydrocortisone 1% two times a day over chest wall field and to wash daily dermatitis area with water and mild soap. Treatment was started from the day of the last session of radiotherapy and continuing every day for 3 weeks. Each patient was examined weekly for 4 weeks. Severity of radiation-induced skin reaction. Timepoint: Just before intervention and then weekly for 4 weeks. Method of measurement: Dermatitis area (cm2) were measured (by grid paper) and estimated. ACTRN12612000837820 ثبت کارآزمائي هاي باليني استراليا و نيوزيلند ACTRN12612000837820 The Australian New Zealand Clinical Trials Registry Vice chancellor for research,, Shiraz University of Medical Sciences Approved 2011-07-05 Medical Research Ethic Committee of Shiraz University of Medical Sciences Medical Research Ethic Committee of Shiraz University of Medical Sciences Shiraz Iran (Islamic Republic of)