To assess the safety and efficacy of Topical Curcumin in treatment and increasing the quality of life in chronic hand eczema patients
Design
two-arm parallel randomized with blinded outcome assessment
Settings and conduct
the study will be conducted on patients referred to dermatology clinics of Shiraz University of Medical Sciences.
the patients and outcome assessor will be blinded to the treatment given to the most extent possible, since they will be not allowed to talk about the color of the ingredients.
Participants/Inclusion and exclusion criteria
patients above 18 years old with chronic hand eczema who consent to participate in the study will enter the study and the ones younger than 18 years old and pregnant and breastfeeding individuals, the ones with chronic kidney disease, hepatic insufficiency and the ones who used corticosteroids or immunomodulators in any form, and the ones who do not consent to participate in the study will be excluded.
Intervention groups
the patients will be divided to two groups one of whom will receive topical momethasone and the other group will receive topical curcumin. each group will be advised to apply the medication twice daily for two months.
Main outcome variables
the severity of chronic hand eczema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240425061563N1
Registration date:2024-05-10, 1403/02/21
Registration timing:prospective
Last update:2024-05-10, 1403/02/21
Update count:0
Registration date
2024-05-10, 1403/02/21
Registrant information
Name
Elham Khajavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3235 1099
Email address
dr.elhamkhajavi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the safety and efficacy of topical curcumin and topical mometasone in treatment of chronic hand eczema; a randomized clinical trial
Public title
topical curcumin for treatment of chronic hand eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients above ۱۸ years of age
with chronic hand eczema
who have not received topical or oral treatments for this condition in the past two weeks
consent to participate in the study
Exclusion criteria:
patients younger than ۱۸ years old
pregnancy
breastfeeding
having underlying disease in need of systemic corticosteroids such as adrenal insufficiency and rheumatologic disease
using topical or oral immunomodulators
chronic kidney disease
hepatic insufficiency
the need for more potent corticosteroids (such as clobetasol)
unwillingness to participate in the study
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of the patients will be performed using a permuted block method by the help of www.randomization.com website and randomization concealment will be achieved using a dark envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
the patients will receive their treatment option from the dermatology clinic in containers that are only different in their name (A or B). although the containing agent of each container differ in color (Mometasone is white and Curcumin is yellow) the physician will not be allowed to talk about the color of the agent in each container. The researcher and the patients will be ignorant regarding the nature of the cream in each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medica Sciences, Zand st.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2024-04-07, 1403/01/19
Ethics committee reference number
IR.SUMS.MED.REC.1403.008
Health conditions studied
1
Description of health condition studied
Chronic Hand Eczema
ICD-10 code
L20.8
ICD-10 code description
Other atopic dermatitis
Primary outcomes
1
Description
severity of chronic hand eczema
Timepoint
8 weeks after treatment initiation
Method of measurement
Hand Eczema Severity Index (HECSI)
Secondary outcomes
1
Description
adverse effects of topical curcumin
Timepoint
8 weeks from initiation of therapy
Method of measurement
interview and physical examination
2
Description
quality of lfe
Timepoint
8 weeks from initiation of therapy
Method of measurement
Dermatologic Life Quality Index (DLQI)
Intervention groups
1
Description
Intervention group: the patients receive topical curcumin made by Exir Nano Sina Company of Iran. the patients will apply the medication twice daily for eight weeks on the affected area.
Category
Treatment - Drugs
2
Description
Control group: the patients receive topical Momethasone furoate 0.1% made by Kish Medipharm Company of Iran. the patients will apply the medication twice daily for eight weeks on the affected area.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Elham Khajavi
Street address
zand st.
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1087
Email
dr.elhamkhajavi@gmail.com
2
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Elham Khajavi
Street address
Namazee Sq.
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Email
dr.elhamkhajavi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Street address
Zand St.
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Elham Khajavi
Position
Senior Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology, Shahid Faghihi Hospital, Zand St.
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5884
Email
dr.elhamkhajavi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Ghahhartars
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology, Shahid Faghihi Hospital, Zand St.
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5884
Email
mghahar@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Kahajavi
Position
Senior Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology, Shahid Faghihi Hospital, Zand St.
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5884
Email
dr.elhamkhajavi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the study will be published in recognized journals. the data will not be publicly available but unidentified data can be shared with fellow researchers through reasonable request.
When the data will become available and for how long
from publication of the article indefinitely
To whom data/document is available
the depersonalized data can be shared with other researchers via reasonable request.
Under which criteria data/document could be used
if the researcher has conducted previous research in this field
From where data/document is obtainable
the data can be shared via email from Dr. Elham Khajavi on dr.elhamkhajavi@gmail.com
What processes are involved for a request to access data/document
the data can be shared after proper introduction and providing the research background of the fellow researchers