Ansari, M., Farzin, F., Mosalaei, A., Omidvari, S., Ahmadloo, N., & Mohammadianpanah, M. (2013). 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. Iranian Journal of Medical Sciences, 38, 293–300.

To compare the efficacy between topical alpha ointment, which contains natural henna, and topical 1% hydrocortisone cream in the healing of radiation-induced dermatitis in patients with breast cancer

Patients in both arms were instructed to wash the area of the treatment field daily. The intervention included topical alpha ointment, which contains natural henna (i.e., Lawsonia inermis Linn), applied twice a day in a thin layer over the chest wall field commencing the last day of treatment and continuing for three weeks. The active control included topical 1% hydrocortisone cream applied twice a day in a thin layer over the chest wall field commencing the last day of treatment and continuing for three weeks. The patient’s dermatitis area was examined independently by two physician raters each week. The patient’s reported skin burning, pain, pruritus, and amount of discharge were recorded during the weekly physician visit. The primary endpoint of the study was speed measured in cm/week of dermatitis healing (i.e., complete reepithelialization of moist desquamation).

• N  = 60 (30 in each arm)    
• AGE = 28–81 years old in the alpha ointment arm; 25–72 years old in the hydrocortisone cream arm
• MALES: Not described, FEMALES: Not described
• KEY DISEASE CHARACTERISTICS: Newly pathologically proven, locally advanced breast cancer (treated with modified radical mastectomy, followed by sequential adjuvant chemotherapy and chest wall radiotherapy [45–50.4 Gy])
• OTHER KEY SAMPLE CHARACTERISTICS: Grade 2 and/or 3 radiation-induced dermatitis

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Shirez, Iran

• PHASE OF CARE: Transition phase after active treatment

• Open-label, randomly-assigned, actively-controlled phase II clinical trial of alpha ointment in the management of grade 2 or 3 radiodermatitis of the breast

• Skin toxicity: Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
• Cumulative radiation dose (Gy)
• Dermatitis area (cm²)
• Dermatitis healing (complete reepithelialization of moist desquamation)
• Healing rate (cm/week)
• Patient-reported “skin burning” (0 = no complaint, 1 = mild, 2 = moderate, 3 = severe)
• Patient-reported “pain” (0 = no complaint, 1 = mild, 2 = moderate, 3 = severe)
• Patient-reported “pruritus” (0 = no complaint, 1 = mild, 2 = moderate, 3 = severe)
• Patient-reported “amount of discharge” (0 = no complaint, 1 = mild, 2 = moderate, 3 = severe)

Originally, 63 patients were assessed for eligibility, and three were ineligible. Of the remaining 60 patients, with 30 in each arm, none were lost to follow-up. There was no statistically significant difference in mean age, dermatitis area, dermatitis grade, and total radiation dose between members of the two arms. The mean area of grade 2 and 3 radiodermatitis was significantly less in the alpha ointment arm (51.64 ± 59.04 cm²) as compared to the hydrocortisone arm (74.77 ± 71.20 cm², p = 0.007) during the second week but not at baseline, the first week, or the third week. There was no difference in patient-reported burning throughout the study. Alpha ointment significantly decreased patient-reported pain (p < 0.001), pruritus (p = 0.009), and the amount of discharge (p = 0.010) at three weeks as compared to hydrocortisone cream.

Alpha ointment significantly enhanced radiation dermatitis healing as compared to hydrocortisone cream. Alpha ointment also reduced patient-reported pain, pruritus, and the amount of discharge, but not skin burning.

• Small sample (< 100)
• Risk of bias (no blinding)
• Other limitations/explanation: The treatments were not blinded. However, one treatment was an ointment while the other was a cream. Did not control for breast size or smoking. Said that “sex” was a variable collected, but did not mention whether males were included in the study. “Sex” was not reported in any of the published statistical analyses. Two physician raters were used to determine the dermatitis area; however, the authors did not include an assessment of inter-rater reliability or how the “final” dermatitis area was determined.

Alpha ointment with an active ingredient of henna may be an effective treatment to manage grades 2 and 3 radiodermatitis. Additional studies are needed.