The evaluation of efficacy of topical use of Nigella cream (Nigella sativa oil-extract) in chonic hand eczema

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2012
INTERVENTION: Intervention 1: 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. Intervention group 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). Intervention 2: We use Eucerin as a creamy base for the nigella oil so we use eucerin as a placebo. The Eucerin cream will be prepared in tubes with the same weight and appearance to nigella cream tubes and randomly will be administered for the patients. In this group the eucerin cream is applied twice daily for 4 weeks in amount of a finger tip units and the maximum dose is 1 gr per each application. Intervention 3: We use Eucerin as a creamy base for the nigella oil so we use eucerin as a base for betamethasone cream too. The betamethasone cream will be prepared in tubes with the same weight and appearance to nigella and placebo cream tubes and randomly will be administered for the patients. In this group the betamethasone cream is applied twice daily for 4 weeks in amount of a finger tip units and the maximum dose is 1 gr per each application. Placebo 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. Intervention group 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). Treatment ‐ Drugs We use Eucerin as a creamy base for the nigella oil so we use eucerin as a placebo. The Eucerin cream will be prepared in tubes with the same weight and appearance to nigella cream tubes and randomly will be administered for the patients. In this group the eucerin cream is applied twice daily for 4 weeks in amount of a finger tip units and the maximum dose is 1 gr per each application. We use Eucerin as a creamy base for the nigella oil so we use eucerin as a base for betamethasone cream too. The betamethasone cream will be prepared in tubes with the same weight and appearance to nigella and placebo cream tubes and randomly will be administered for the patients. In this group the betamethasone cream is applied twice daily for 4 weeks in amount of a finger tip units and the maximum dose is 1 gr per each application. CONDITION: Dermatitis, unspecified Eczema NOS hand eczema. ; Dermatitis, unspecified Eczema NOS PRIMARY OUTCOME: Quality of life. Timepoint: 2 weeks. Method of measurement: Dermatology Life Quality Index (DLQI). Resolution of severity and intensity of lesions. Timepoint: 2 weeks. Method of measurement: Hand Eczema Severity Index (HECSI). SECONDARY OUTCOME: Irritant or allergic contact dermatitis. Timepoint: 4 weeks. Method of measurement: physician assessment. INCLUSION CRITERIA: Inclusion criteria: ‐ age between 18‐60 y/o ‐ patients should be eager to participate in trial ‐patients should have chronic hand eczema that is confirmed by two dermatologist separetely Exclusion criteria: ‐pregnancy and lactation ‐application of topical drugs during previous two weeks ‐usage of systemic therapies such as corticosteroids and immunosupressive drugs and antibiotics during the past 4 weeks ‐ localized hand infection ‐history of hand contact dermatitis due to topical drugs including herbal remedies
Epistemonikos ID: 3386ab4b4bfcd14d6d7d721cf6712aa4a22ea24e
First added on: Apr 23, 2019