Formulation, standardization and physicochemical control of topical preparation from lemongrass (Cymbopogon citratus (DC.) Stapf) and
evaluation of its effect on contact dermatitis
Design
Two arm parallel groups randomized trial with blinded postoperative care and outcome assessment
online randomization using www.graphpad.com
sample size : 50 people
third phase of clinical trial
Settings and conduct
we will study referrals to skin and stem cells center of Tehran university of medical science.
Patients will be divided into 2 groups accidentally. The first group will receive topical cream which contains herbal extract and the second group will receive placebo instead. Patients should use their medications twice a day for 8 weeks.
All patients will be examined at first day of study (before using medication), 28th day and 56th day of study. Every session EASI and CTCAE questionnaires will be filled out by physician and pharmacist and pharmacist will take a picture of patients lesions.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.patients who suffer from mild to moderate contact dermatitis according to EASI
2.patient older than 18 years old
exclusion criteria:
1.patients who have received oral corticosteroids two months before study
2.patients who have received topical immunosuppressant one months before study
3.pregnant women
4.breastfeeding women
5.patients who have contact dermatitis history to herbal formulations
6.patients who have skin infections
7.patients who have immunosuppressive diseases
Intervention groups
This study has 2 groups: first group will receive herbal formulation and control group will receive placebo
Main outcome variables
reduction in size of contact dermatitis lesions
reduction in inflammation and pruritus in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190425043372N1
Registration date:2020-02-06, 1398/11/17
Registration timing:registered_while_recruiting
Last update:2020-02-06, 1398/11/17
Update count:0
Registration date
2020-02-06, 1398/11/17
Registrant information
Name
Soodeh Karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 6528
Email address
s-karami@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation and physicochemical characterization of the topical preparation from Cymbopogon citratus (DC.) Stapf. and its effect on contact dermatitis
Public title
Effect of Cymbopogon citratus on contact dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years old
Patients who suffers from mild to moderate contact dermatitis according to EASI index
Exclusion criteria:
Patients who have used oral corticosteroides, 2 months before study
Patients who have used topical immunosuppressants 4 weeks before study
Pregnant women
Breastfeeding women
Patients who have contact dermatitis history to herbal formulations
Patients who have skin infections
Patients who have immunosuppressive diseases
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Online randomization using www.graphpad.com website, this website gives number 1 or number 2 codes to each 50 patients.
Allocation concealment: Randomized Numbered drug containers: Formulations will be put in sealed little boxes with labels of 1 or 2 on them.
Blinding (investigator's opinion)
Double blinded
Blinding description
All formulations will be divided into two groups with 1 and 2 codes. number 1 belongs to the formulations which contains herbal extract and number 2 belongs to the formulations that are placebo. Patients and physician will not be informed about formulations content, just researcher (pharmacist) will be aware of formulations.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
medicine fculty, northern entrance, Poorsina street, Qods street, Enqelab street
City
Tehran
Province
Tehran
Postal code
1417863181
Approval date
2019-03-04, 1397/12/13
Ethics committee reference number
IR.TUMS.VCR.REC.1397.1027
Health conditions studied
1
Description of health condition studied
Contact dermatitis
ICD-10 code
L24
ICD-10 code description
Irritant contact dermatitis
Primary outcomes
1
Description
Eczema score according to EASI
Timepoint
Measuring EASI index at first day of study (before using topical formulation), 28 and 56 days after using formulation
Method of measurement
Eczema Area and Severity Index (EASI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: topical cream containing Cymbopogon citratus oil with paraffin base formulated in tehran university of medical science Iranian medicine faculty ,consumption instruction: twice a day for eight weeks
Category
Treatment - Drugs
2
Description
Control group: topical cream containing paraffin formulated in Tehran university of medical science Iranian medicine faculty ,consumption instruction: twice a day for eight weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin & Stem Cell Research Center Tehran University of Medical Sciences
Full name of responsible person
Soodeh karami
Street address
No 4. Maryam Alley. South Kamranyeh Street, Skin and Stem Cell Research Center
City
Tehran
Province
Tehran
Postal code
19379-57511
Phone
+98 21 2221 5558
Email
soodeh_karami@yahoo.com
Web page address
http://skinstemcell.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Roja Rahimi
Street address
No 27,North Sarparast street ,West Taleqani street,Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8897 6527
Email
rojarahimi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Soodeh Karami
Position
PHD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 180,Enqelab Blvd. ,Shahid Beheshti street ,Qods Town,Dr Soodeh Karami pharmacy
City
Tehran
Province
Tehran
Postal code
3751874431
Phone
+98 21 4683 0133
Email
s-karami@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soodeh Karami
Position
PHD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 180,Enqelab Blvd. ,Shahid Beheshti street ,Qods Town,Dr Soodeh Karami pharmacy
City
Tehran
Province
Tehran
Postal code
3751874431
Phone
+98 21 4683 0133
Email
s-karami@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soodeh Karami
Position
PHD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 180,Enqelab Blvd. ,Shahid Beheshti street ,Qods Town,Dr Soodeh Karami pharmacy
City
Tehran
Province
Tehran
Postal code
3751874431
Phone
+98 21 4683 0133
Email
s-karami@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD