title: Efficacy of topical alpha ointment (containing natural henna) compared to topical hydrocortisone (1%) in the healing of radiation-induced dermatitis in patients with breast cancer: a randomized controlled clinical trial.
abstract: BACKGROUND
  This two-arm, randomized clinical study aimed to compare efficacy between topical Alpha ointment and topical hydrocortisone cream (1%) in the healing of radiation-induced dermatitis in breast cancer patients.
  
  
  METHODS
  The inclusion criteria comprised newly pathologically proven, locally advanced breast cancer (treated with modified radical mastectomy followed by sequential adjuvant treatments, including chest wall radiotherapy [45-50.4 Gy]) and grade 2 and/or 3 chest wall dermatitis. The exclusion criteria were comprised of any underlying disease or medications interfering with the wound healing process, previous history of chest wall radiotherapy, and concurrent use of chemotherapy. Sixty eligible patients were randomly assigned to use either topical Alpha ointment (study arm, n=30) or topical hydrocortisone cream (1%) (control arm, n=30) immediately after receiving a total dose of 45-50 Gy chest wall radiotherapy.
  
  
  RESULTS
  The mean radiation dose was 49.1 Gy in the control arm and 48.8 Gy in the study arm. The mean dermatitis area was 13.54 cm(2) in the control arm and 17.02 cm(2) in the study arm. Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) (P=0.001). This effect was significant in the second week (P=0.007). In addition, Alpha ointment decreased the patients' complaints such as pain (P<0.001), pruritus (P=0.009), and discharge (P=0.010) effectively and meaningfully.
  
  
  CONCLUSIONS
  Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) in our patients with breast cancer.
  
  
  BACKGROUND
  IRCT201206099979N1, ACTRN12612000837820.
authors.affiliation: Department of Radiation Oncology, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran;
authors.forename: Mansour
authors.initials: M
authors.lastname: Ansari
authors.forename: Dehsara
authors.initials: D
authors.lastname: Farzin
authors.forename: Ahmad
authors.initials: A
authors.lastname: Mosalaei
authors.forename: Shapour
authors.initials: S
authors.lastname: Omidvari
authors.forename: Niloofar
authors.initials: N
authors.lastname: Ahmadloo
authors.forename: Mohammad
authors.initials: M
authors.lastname: Mohammadianpanah
keywords: Breast cancer; Hydrocortisone; Radiation-induced dermatitis; Radiotherapy