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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

Protocol summary

Summary
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.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111266959N3
Registration date: 2012-01-11, 1390/10/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-01-11, 1390/10/21
Registrant information
Name
Behrooz Barikbin
Name of organization / entity
skin research center, shohada tajrish hospital, tehran, iran.
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1507
Email address
b_barikbin@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Skin research center of Shahid Beheshti medical universiy
Expected recruitment start date
2010-01-01, 1388/10/11
Expected recruitment end date
2012-03-31, 1391/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The evaluation of efficacy of topical use of Nigella cream (Nigella sativa oil-extract) in chonic hand eczema
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti university of medical sciences
Street address
Shahid beheshti medical university, Velenjak
City
Tehran
Postal code
Approval date
2009-12-29, 1388/10/08
Ethics committee reference number
88/814 م/ ت/ پ

Health conditions studied

1

Description of health condition studied
hand eczema
ICD-10 code
L30.9
ICD-10 code description
Dermatitis, unspecified Eczema NOS

Primary outcomes

1

Description
quality of life
Timepoint
2 weeks
Method of measurement
Dermatology Life Quality Index (DLQI)

2

Description
resolution of severity and intensity of lesions
Timepoint
2 weeks
Method of measurement
Hand Eczema Severity Index (HECSI)

Secondary outcomes

1

Description
Irritant or allergic contact dermatitis
Timepoint
4 weeks
Method of measurement
physician assessment

Intervention groups

1

Description
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).
Category
Treatment - Drugs

2

Description
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.
Category
Placebo

3

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology department of Loghman e Hakim hospital
Full name of responsible person
Behrooz Barikbin
Street address
Loghman e Hakim hospitalو Makhsus st, Charrah e Lashkar, Karegar st
City
Tehran

2

Recruitment center
Name of recruitment center
Dermatology department of Shohada e Tajrish hospital
Full name of responsible person
Maryam Usefi
Street address
Shohada e Tajrish hospital, Tajrish sq
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Skin research center of Shahid Beheshti university of medical sciences
Full name of responsible person
Parviz Tousi
Street address
Shohada e Tajrish hospital, Tajrish Sq
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin research center of Shahid Beheshti university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Skin research center of Shahid Beheshti university of medical sciences
Full name of responsible person
Behrooz Barikbin
Position
professor assistant
Other areas of specialty/work
Street address
Shohada e Tajrish hospital, Tajrish Sq
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
b_barikbin@sbmu.ac.ir
Web page address
queenderma.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
skin research center of Shahid Beheshti university of medical sciences
Full name of responsible person
Behrooz Barikbin
Position
assistant professor
Other areas of specialty/work
Street address
Shohada e Tajrish hospital, Tajrish Sq
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
b_barikbin@sbmu.ac.ir
Web page address
queenderma.com

Person responsible for updating data

Contact
Name of organization / entity
Skin research center of Shahid Beheshti university of medical sciences
Full name of responsible person
Atyeh Ebadi
Position
resident of dermatology
Other areas of specialty/work
Street address
Shohada e Tajrish hospital,Tajrish Sq
City
Tehran
Postal code
Phone
Fax
Email
aty_ebadi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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