Evaluation of clinical efficacy of topical formulation of ruxolitinib 1.5% in treatment of atopic dermatitis
Design
Phase II single group. before -after
Settings and conduct
This clinical and interventional before-after study is performed in Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences. 20 patients with dermatitis atopic who want to participate in the study and complete the consent form are entered in the study. They receive topical emulgel ruxolitinib 1.5% twice daily for 4 weeks and the rate of healing is evaluated 2 and 4 weeks after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Case of mild to moderate atopic dermatitis
Exclusion criteria: Pregnancy and lactation and sever atopic dermatitis
Intervention groups
Intervention group: Topical use of emulgel of nanoliposomes contain ruxolitinib 1.5 percent produced by lipid film hydration method in the faculty of pharmacy of Tehran university of medical sciences twice a day and for 4 weeks
Main outcome variables
severity of lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161207031288N9
Registration date:2021-06-01, 1400/03/11
Registration timing:prospective
Last update:2021-06-01, 1400/03/11
Update count:0
Registration date
2021-06-01, 1400/03/11
Registrant information
Name
Saman Ahmad Nasrollahi
Name of organization / entity
Center for Research and Training in Skin Diseases and Leprosy Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 8190
Email address
snasrollahi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-10, 1400/03/20
Expected recruitment end date
2021-12-11, 1400/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical study of topical nanoliposome formulation of ruxolitinib 1.5% in treatment of mild to moderate atopic dermatitis
Public title
Clinical study of topical nanoliposome formulation of ruxolitinib 1.5% in treatment of eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Case of mild to moderate atopic dermatitis (SCORAD between 4 and 12)
Older than 18 years
Signing informed consent to participate in the study
Having a negative pregnancy test
Willingness to actively participate in the study
Exclusion criteria:
Pregnancy and lactation
Use of any topical corticosteroids in the last 14 days
Drug and alcohol addiction
Use of oral corticosteroids or other immunosuppressive drugs in the last 28 days
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University Of Medical Sciences(TUMS)
Street address
Taleghani and Naderi intersection-Center for Research and Training of Skin Disease and Leprosy
City
Tehran
Province
Tehran
Postal code
1416613675
Approval date
2019-02-17, 1397/11/28
Ethics committee reference number
IR.TUMS.TIPS.REC.1397.142
Health conditions studied
1
Description of health condition studied
Atopic dermatitis
ICD-10 code
L20
ICD-10 code description
Atopic dermatitis
Primary outcomes
1
Description
severity of lesions of atopic dermatitis according to Scorad score
Timepoint
Before intervention, and 2 and 4 weeks after than
Method of measurement
Clinical exam
Secondary outcomes
1
Description
Dermal erythema variations
Timepoint
Before intervention, and 2 and 4 weeks after than
Method of measurement
Mexameter
Intervention groups
1
Description
Intervention group: Topical use of emulgel of nanoliposomes contain ruxolitinib 1.5 percent produced by lipid film hydration method in the faculty of pharmacy of Tehran university of medical sciences twice a day and for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Research and Training in Skin Diseases and Leprosy
Full name of responsible person
Dr. Alireza Firooz
Street address
Taleghani-Naderi intersection
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8899 3305
Email
dermalab@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Rouini
Street address
16 Azar
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 8897 2220
Email
pharmacy@tums.ac.ir
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
Centre for Research and Training in Skin Diseases and Leprosy
Full name of responsible person
Dr. Alireza Firooz
Position
Dermatologist, Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Taleghani-Naderi intersection
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Centre for Research and Training in Skin Diseases and Leprosy
Full name of responsible person
Dr. Alireza Firooz
Position
Dermatologist, Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Taleghani-Naderi intersection
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Atefeh Naeimifar
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
16 Azar
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 2653
Email
naimifar@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available