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

The evaluation of efficacy of topical use of Nigella cream (Nigella sativa oil-extract) in comparison with topical use of 0.1% Betamethasone and Eucerin on the clinical severity and quality of life in patients with chonic hand eczema reffering to Loghman-e-Hakim and Shohada-e-Tajrish hospitals during the year 1388-1389

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201111266959N3
Enrollment
60
Registered
2012-01-11
Start date
2010-01-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hand eczema. Dermatitis, unspecified Eczema NOS

Interventions

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 p
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
Treatment - Drugs
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
the amount of applied creams is estimated by Finger Tip Unit (FTU).
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 r
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 n

Sponsors

Skin research center of Shahid Beheshti university of medical sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Irritant or allergic contact dermatitis. Timepoint: 4 weeks. Method of measurement: physician assessment.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehrooz Barikbin

Skin research center of Shahid Beheshti university of medical sciences

b_barikbin@sbmu.ac.ir+98 21 2274 1507

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026