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Effect of topical N-acetyl cysteine cream versus topical corticosteroid on treatment of chronic eczema of the hand: a double-blind randomized clinical trial

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History
# Registration date Revision Id
2 2019-11-27, 1398/09/06 112019
1 2019-01-13, 1397/10/23 75126
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  • Protocol summary

    To assess the effect of topical N-acetyl cysteine cream versus topical corticosteroid on the treatment of chronic eczema of the hand
    To assess the effect of topical oatmeal cream versus topical placebo cream on the treatment of chronic eczema of the hand
    تعيين اثر کرم ان-استیل سیستئین موضعی نسبت به کرم کورتیکواستروئید موضعی در درمان اگزمای مزمن دست
    تعيين اثر کرم موضعی جو دوسر نسبت به کرم موضعی دارونما در درمان اگزمای مزمن دست
    Intervention group: Topical use of N-acetyl cysteine cream 20%, manufactured by Osveh Co., twice a day for 4 weeks Control group: Topical use of Fluocinolone cream 0.025%, manufactured by Behvarzan Co., twice a day for 4 weeks
    Intervention group: Topical Fluocinolone cream 25% (Manufactured by Behvarzan Pharmaceutical Company) plus topical oatmeal cream 1% (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical oatmeal cream 1% alone for 4 weeks Control group: Topical Fluocinolone cream 25% (Manufactured by Behvarzan Pharmaceutical Company) plus topical placebo cream (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical placebo cream alone for 4 weeks
    گروه مداخله: مصرف موضعی کرم ان-استیل سیستئین 20 درصد ساخت شرکت داروسازی اسوه روی ضایعات پوستی روزی 2 بار به مدت 4 هفته گروه کنترل: مصرف موضعی کرم فلوئوسینولون موضعی 0.025 درصد ساخت شرکت دارویی بهورزان روی ضایعات پوستی روزی 2 بار به مدت 4 هفته
    گروه مداخله: کرم فلوسینولون موضعی 25 درصد (ساخت شرکت دارویی بهورزان) بعلاوه کرم موضعی جو دوسر یک درصد (ساخت لابراتوار دانشکده داروسازی دانشگاه علوم پزشکی همدان) به مدت 2 هفته و سپس کرم موضعی جو دوسر یک درصد به تنهایی به مدت 4 هفته گروه کنترل: کرم فلوسینولون موضعی 25 درصد (ساخت شرکت دارویی بهورزان) بعلاوه کرم موضعی دارونما (ساخت لابراتوار دانشکده داروسازی دانشگاه علوم پزشکی همدان) به مدت 2 هفته و سپس کرم موضعی دارونما به تنهایی به مدت 4 هفته

  • Primary outcomes

    #1
    Before the intervention and 2 and 4 weeks after the intervention
    Before the intervention and 2 and 6 weeks after the intervention
    قبل از مداخله و 2 و 4 هفته بعد از مداخله
    قبل از مداخله و 2 و 6 هفته بعد از مداخله
    #2
    Before the intervention and 2 and 4 weeks after the intervention
    Before the intervention and 2 and 6 weeks after the intervention
    قبل از مداخله و 2 و 4 هفته بعد از مداخله
    قبل از مداخله و 2 و 6 هفته بعد از مداخله

  • Intervention groups

    #1
    Intervention group: Topical use of N-acetyl cysteine cream 20%, manufactured by Osveh Co., twice a day for 4 weeks
    Intervention group: Topical Flucinolone cream 25% (Manufactured by Behvarzan Pharmaceutical Company) plus topical oatmeal cream 1% (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical oatmeal cream 1% alone for 4 weeks
    گروه مداخله: مصرف موضعی کرم ان-استیل سیستئین 20 درصد ساخت شرکت داروسازی اسوه روی ضایعات پوستی روزی 2 بار به مدت 4 هفته
    گروه مداخله: کرم فلوسینولون موضعی 25 درصد (ساخت شرکت دارویی بهورزان) بعلاوه کرم موضعی جو دوسر یک درصد (ساخت لابراتوار دانشکده داروسازی دانشگاه علوم پزشکی همدان) به مدت 2 هفته و سپس کرم موضعی جو دوسر یک درصد به تنهایی به مدت 4 هفته
    #2
    Treatment - Drugs
    Placebo
    Control group: Topical use of Fluocinolone cream 0.025%, manufactured by Behvarzan Co., twice a day for 4 weeks
    Control group: Topical Flucinolone cream 25% (Manufactured by Behvarzan Pharmaceutical Company) plus topical placebo cream (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical placebo cream alone for 4 weeks
    گروه کنترل: مصرف موضعی کرم فلوئوسینولون موضعی 0.025 درصد ساخت شرکت دارویی بهورزان روی ضایعات پوستی روزی 2 بار به مدت 4 هفته
    گروه کنترل: کرم فلوسینولون موضعی 25 درصد (ساخت شرکت دارویی بهورزان) بعلاوه کرم موضعی دارونما (ساخت لابراتوار دانشکده داروسازی دانشگاه علوم پزشکی همدان) به مدت 2 هفته و سپس کرم موضعی دارونما به تنهایی به مدت 4 هفته

  • Recruitment centers

    #1
    Name of recruitment center - English: Sina Hospital in Hamadan City
    Name of recruitment center - Persian: بیمارستان سینا شهر همدان
    Full name of responsible person - English: Masa Hojati
    Full name of responsible person - Persian: مهسا حجتی
    Street address - English: School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
    Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان، دانشکده داروسازی
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: School of Pharmacy,
    Phone: +98 81 3838 0572
    Fax:
    Email: hojati90@gmail.com
    Web page address:
    Name of recruitment center - English: Sina Hospital in Hamadan City
    Name of recruitment center - Persian: بیمارستان سینا شهر همدان
    Full name of responsible person - English: Masa Hojati
    Full name of responsible person - Persian: مهسا حجتی
    Street address - English: Sina Hospital, Mirzadeh Eshghi Ave.
    Street address - Persian: خیابان میرزاده عشقی، بیمارستان سینا
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 6517838695
    Phone: +98 81 3827 4184
    Fax:
    Email: hojati90@gmail.com
    Web page address:

Protocol summary

Study aim
To assess the effect of topical oatmeal cream versus topical placebo cream on the treatment of chronic eczema of the hand
Design
This is a double-blind randomized clinical trial, phase II, in which 70 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
Setting and conduct: The eligible patients with chronic eczema of the hand who will refer to Sina Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded so that the shape of the two types of cream will be similar and patients will not be aware of the type of cream they use. In addition, the assignment of the patients to the intervention and control groups will be done by a third person, therefore, the physician who will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 12 to 65 years; Chronic eczema of the hand Exclusion criteria: Pregnancy or breastfeeding; Other concurrent skin lesions such as psoriasis; Immunodeficiency
Intervention groups
Intervention group: Topical Fluocinolone cream 25% (Manufactured by Behvarzan Pharmaceutical Company) plus topical oatmeal cream 1% (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical oatmeal cream 1% alone for 4 weeks Control group: Topical Fluocinolone cream 25% (Manufactured by Behvarzan Pharmaceutical Company) plus topical placebo cream (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical placebo cream alone for 4 weeks
Main outcome variables
Primary outcome: The severity of pruritus, The severity of skin lesions

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N257
Registration date: 2019-01-13, 1397/10/23
Registration timing: registered_while_recruiting

Last update: 2019-11-28, 1398/09/07
Update count: 1
Registration date
2019-01-13, 1397/10/23
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-31, 1397/10/10
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical N-acetyl cysteine cream versus topical corticosteroid on treatment of chronic eczema of the hand: a double-blind randomized clinical trial
Public title
Effect of topical N-acetyl cysteine cream versus topical corticosteroid on treatment of chronic eczema of the hand
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 12 to 65 years; Chronic eczema of the hand
Exclusion criteria:
Pregnancy or breastfeeding; Other concurrent skin lesions such as psoriasis; Immunodeficiency
Age
From 12 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications will be perfectly the same in the two groups. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-09-01, 1397/06/10
Ethics committee reference number
IR.UMSHA.REC.1397.398

Health conditions studied

1

Description of health condition studied
Eczema
ICD-10 code
L20.84
ICD-10 code description
Intrinsic (allergic) eczema

Primary outcomes

1

Description
The severity of pruritus
Timepoint
Before the intervention and 2 and 6 weeks after the intervention
Method of measurement
By taking history

2

Description
The severity of skin lesions
Timepoint
Before the intervention and 2 and 6 weeks after the intervention
Method of measurement
By clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Topical Flucinolone cream 25% (Manufactured by Behvarzan Pharmaceutical Company) plus topical oatmeal cream 1% (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical oatmeal cream 1% alone for 4 weeks
Category
Treatment - Drugs

2

Description
Control group: Topical Flucinolone cream 25% (Manufactured by Behvarzan Pharmaceutical Company) plus topical placebo cream (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical placebo cream alone for 4 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital in Hamadan City
Full name of responsible person
Masa Hojati
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
hojati90@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Masa Hojati
Position
Student of pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
hojati90@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Maryam Mehrpooya
Position
Pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
m_mehrpooya2003@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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