Aim: This randomized controlled patient-blinded pilot study is designed to show the effect of nigella cream on improving quality of life and severity of hand eczema in contrast to betamethasone and eucerin cream.
Inclusion criteria: hand eczema due to either occupational dermatitis, atopic dermatitis, or irritant dermatitis of the hands (bilateral or unilateral)
Exclusion criteria: pregnancy, lactation, history of allergic reaction to the study medications, local infection in the site of eczema
Study population: Sixty eligible patients of dermatologic clinics of Loghman and Shohada-e-Tajrish hospitals will be enrolled in the study.
Intervention: The nigella cream with eucerin base is made by a valid pharmacology company. For blinding the participants but not investigators, all three creams( Nigella, Betamethasone, eucerin as placebo) will be prepared in the identical tubes which only labeled A, B, and C with no other information. Participants will apply maximally one gram of study drugs topically on eczematous lesions twice a day for a period of four weeks; the amount of applied creams is estimated by Finger Tip Unit (FTU).
Duration of the study: during January 2010 to March 2012
Primary outcome: Patients will be assessed at 3 determined time points: at first attending session, at weeks two and four after initiating treatment. The Hand Eczema Severity Index (HECSI) will be used to assess the extent, severity and improvement of the disease during each session. Farsi version of Dermatologic Life Quality Index (DLQI) that its validity and reliability in assessing vitiligo is confirmed previously will be used too.