Major objectives: Effect of Anti-dry cream (contains essences of Lavender, Geranium, and Aloe vera ) on improving manifestations of hand eczema in comparison with Fluocinolone acetonide 0.025% cream. Design: Randomized controlled double-blinded study. Setting and conduct: 108 eligible patients with hand eczema attending to dermatologic clinic will be enrolled in this study after filling consent form and randomized into two groups (control and intervention group). Inclusion criteria: Patients with hand eczema that is confirmed by dermatologist; age between 18-75 y/o; patients should be eager to participate in trial. Exclusion criteria: Pregnancy and lactation; application of topical drugs during previous two weeks; systemic therapies such as corticosteroids, and antibiotics during the past 4 weeks; localized hand infection; history of allergic reaction to the study medications. Intervention: Anti-dry cream and Fluocinolone acetonide 0.025% will be prepared in the identical tubes which only labeled by numbers. Participants will apply maximally one gram of medications topically on eczematous lesions twice a day for a period of two weeks; the amount of applied creams is estimated by Finger Tip Unit (FTU). Main outcome: Patients will be assessed at 2 determined time points: at first attending session and two weeks after initiating treatment. A Questionnaire (contains of clinical signs and symptoms: erythema, scaling, lichenification/ hyperkeratosis, edema,vesicle, fissure, pruritus and pain) will be filled out by dermatologist in the days of 0 and 14. The Hand Eczema Severity Index will be used to assess the extent, severity and improvement of the disease during each session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212303734N2
Registration date:2013-08-30, 1392/06/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-30, 1392/06/08
Registrant information
Name
Rezvan Talaee
Name of organization / entity
Kashan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1445 5370
Email address
talaei-re@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan university of medical sciences, Barij essence herbal medicine research center
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating of Anti-dry cream vs Flucinolone acetonide 0/o25% cream in treatment of hand eczema
Public title
Efficacy of Anti-dry cream in treatment of hand eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Main inclusion criteria: age between 18-75y/o; patients should be eager to participate in trial; patients with hand eczema that is confirmed by dermatologist.
Main exclusion criteria: pregnancy and lactation; application of topical drugs during previous two weeks; systemic therapies such as corticosteroids, immunosupressive drugs and antibiotics during the past 4 weeks; localized hand infection; history of allergic reaction to the study medications.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Kashan university of medical sciences
Street address
5th kilometer of Ghotb Ravandi Bulvard
City
Kashan
Postal code
87159/88141
Approval date
2011-08-09, 1390/05/18
Ethics committee reference number
29/5/1/1392/ب
Health conditions studied
1
Description of health condition studied
Hand eczema
ICD-10 code
ICD-10: L3
ICD-10 code description
ICD-10: Dermatitis unspecified Eczema NOS
Primary outcomes
1
Description
Change of signs and symptoms of hand eczema
Timepoint
The days of 0 and 14
Method of measurement
Questionnaire (contains of clinical signs and symptoms: erythema, scaling, lichenification/ hyperkeratosis, edema,vesicle, fissure, pruritus and pain)
Secondary outcomes
1
Description
Side effects of drugs
Timepoint
14 days after prescription of drug
Method of measurement
Change of pruritus, erythema and scaling, bullae
Intervention groups
1
Description
Intervention group: Anti dry® cream (contains Aleo vera essence, Geranium essence, Lavander essence, respectively, with ratio of 50:1:15 in vanishing cream), 1FTU (finger tip unit= 0.5g) for 10×10 cm2, twice daily, for two weeks.
Category
Treatment - Drugs
2
Description
control group: fluocinolon acetonide cream 0.025%, twice daily, for two weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic of Beheshti hospital
Full name of responsible person
Rezvan Talaee
Street address
Beheshti hospital, 5th kilometer of Ghotbravandi Bul.
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Essence Herbal Medicine Research Center
Full name of responsible person
Dr. Reza Bekhradi
Street address
Po Box 1178, Mashhad Ardehal
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Essence Herbal Medicine Research Center
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Kashan university of medical sciences, 5th Kilometer of Ghotb Ravandi Bulvard
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan University of Medical Sciences
Proportion provided by this source
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
Kashan university of medical sciences
Full name of responsible person
Rezvan Talaee
Position
Assistant professor
Other areas of specialty/work
Street address
Dermatology department of Beheshti hospital, 5th kilometer of Ghotb Ravandi Bulvard
City
Kashan
Postal code
87159/88141
Phone
+98 361555002126
Fax
+98 36 1555 9800
Email
R_talaee2007@yahoo.com
Web page address
www.kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan university of medical sciences
Full name of responsible person
Rezvan Talaee
Position
Assistant professor
Other areas of specialty/work
Street address
Dermatology department of Beheshti hospital, 5th Km of Ghotb Ravandi Bulvard
City
Kashan
Postal code
87159/88141
Phone
+98 361555002126
Fax
+98 36 1555 9800
Email
R_Talaee2007@yahoo.com
Web page address
www.kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
kashan university of medical sciences
Full name of responsible person
Rezvan Talaee
Position
Assistant professor
Other areas of specialty/work
Street address
Dermatology Department of Beheshti hospital, 5th km of Ghotb Ravandi Bulvard
City
Kashan
Postal code
87159/88141
Phone
+98 361555002126
Fax
+98 36 1555 9800
Email
R_Talaee2007@yahoo.com
Web page address
www.kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)