A clinical trial to evaluate the effect of topical liposomal formulation of Althaea officinalis and compare it with topical hydrocortisone acetate (1%) ointment in improving and control symptom in patients with atopic eczema
The aim of this study is comparing the effect of liposomal formulations containing the Althaea officinalis extract with 1% hydrocortisone cream to relieve the symptoms of atopic dermatitis.In this study all of patients have criterias atopic dermatitis and the exclusion criteria are include sensitivity to the new formulation, simultaneous existence another skin disease or used of systemic immunosuppressive medications .study are done in 20 patients ranging in age from 10 to 40 years with confirmed clinical criteria by allergist. After consent from the patient,in the double-blind form they receive liposomal formulations of Althaea officinalis extract and placebo for a month simultaneously in packages. Patient use these packets the on half of the body lesion and taking hydrocortisone 1% on the other half of the body lesion during per month. Based on questionnaire every two weeks (two times in each month ) the effect of formulations (drug or placebo) with 1% hydrocortisone cream will compare to measure symptoms relieve (tingling, itching, redness, bumps, scaling and fissures)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102323235N5
Registration date:2016-12-21, 1395/10/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-21, 1395/10/01
Registrant information
Name
Farahzad Jabbari Azad
Name of organization / entity
Allergy Research Center, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2770
Email address
jabbarif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-04-13, 1395/01/25
Expected recruitment end date
2017-04-14, 1396/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to evaluate the effect of topical liposomal formulation of Althaea officinalis and compare it with topical hydrocortisone acetate (1%) ointment in improving and control symptom in patients with atopic eczema
Public title
The impact of Althaea officinalis formulation on controlling the symptoms of atopic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Confirm eczema atopic dermatitis by an allergist according to plan; family history of atopy; positive allergy tests (skin prick test) ; Complete the consent form
Exclusion criteria
Local sensitivity to new formulations; Patients with diseases of the skin; Systemic immunosuppressive drugs; Lack of cooperation during treatment; waste infections that require antibiotics or drug penetration increase; patients with atopic eczema lesions with high emissions (over 50%) of body surface
Age
From 10 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashahd University of Medical Science
Street address
Azadi squre
City
Mashhad
Postal code
Approval date
2016-04-13, 1395/01/25
Ethics committee reference number
IR.MUMS.fm.REC.1394.543
Health conditions studied
1
Description of health condition studied
Atopic Eczema
ICD-10 code
L20.8
ICD-10 code description
Other atopic dermatitis
Primary outcomes
1
Description
The severity of the itch
Timepoint
monthly
Method of measurement
questionnaire
2
Description
inflammation
Timepoint
monthly
Method of measurement
questionnaire
3
Description
The size of the lesion
Timepoint
monthly
Method of measurement
questionnaire
Secondary outcomes
1
Description
The severity of the itch
Timepoint
monthly
Method of measurement
questionnaire
2
Description
The inflammation
Timepoint
monthly
Method of measurement
questionnaire
3
Description
The size of the lesion
Timepoint
monthly
Method of measurement
questionnaire
Intervention groups
1
Description
in Control groups, the liposomal placebo in half of the body (right) and in the second half (left) of hydrocortisone ointment is used locally for a month
Category
Placebo
2
Description
in the Intervention group, the Althaea officinalis liposomal in half of the body (right) and in the second half (left) of the body hydrocortisone ointment is used locally for a month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mommamad Mohammadzadeh Shabestari
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
university street
City
Mashhad
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, Mashhad University of Medical Sciences
Proportion provided by this source
100
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
Mashad Universityof Medcal Science
Full name of responsible person
Mommamad Mohammadzadeh Shabestari
Position
General Medicine Students
Other areas of specialty/work
Street address
Azadisquare
City
Mashhad
Postal code
Phone
00
Fax
Email
Mohammad_701@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Allergy Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
Full name of responsible person
Farahzad Jabbari Azad, MD
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Immunology and Allergy, Hospital Ghaem, Ahmadabad streets, Mashhad Mashhad
City
Mashhad
Postal code
Phone
+98 51 3845 8769
Fax
Email
Jabbarif@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Farzaneh Iravani
Position
MSc of human genetics
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Phone
00
Fax
Email
farzaneh.baroon@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)