To assess the topical effect of gel containing bisabolol nanocapsules 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 gel 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 gel containing bisabolol nanocapsules (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical gel containing bisabolol nanocapsules alone for 4 weeks Control group: Topical Fluocinolone cream 25% (Manufactured by Behvarzan Pharmaceutical Company) plus topical placebo gel (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical placebo gel 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:IRCT20200115046143N2
Registration date:2021-06-25, 1400/04/04
Registration timing:prospective
Last update:2021-06-25, 1400/04/04
Update count:0
Registration date
2021-06-25, 1400/04/04
Registrant information
Name
Seyed Yaser Vafaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3426 6353
Email address
y.vafaei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-23, 1400/09/02
Expected recruitment end date
2023-02-21, 1401/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation and clinical evaluation of hydrogel containing bisabolol nanocapsules for treatment of dermatitis
Public title
Formulation and clinical evaluation of hydrogel containing bisabolol nanocapsules for treatment of dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
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
2021-06-12, 1400/03/22
Ethics committee reference number
IR.UMSHA.REC.1400.225
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: Intervention group: Topical Flucinolone cream 0.25% (Manufactured by Behvarzan Pharmaceutical Company) plus topical gel containing bisabolol nanocapsules (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical gel containing bisabolol nanocapsules alone for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: Topical Flucinolone cream 0.25% (Manufactured by Behvarzan Pharmaceutical Company) plus topical placebo gel (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical placebo gel alone for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan City
Full name of responsible person
Homa Karami
Street address
Sina Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
homa1karami@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
Homa Karami
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
homa1karami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Seyed Yaser Vafaei
Position
Assistant professor of pharmaceutics
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
y.vafaei@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
ِDr Seyed Yase Vafaei
Position
Assistant professor of pharmaceutics
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
y.vafaei@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