Comparison of the effect of oral isotretinoin with isotretinoin and des loratadine in the treatment of moderate and severe acne vulgaris
Design
A clinical trial with a control group, parallel groups, single-blind, phase 3 on 60 patients. Non-random, assigning individuals to groups using the file numbers (even or odd).
Settings and conduct
Samples will be selected from patients referred to Isfahan University of Medical Sciences. Patients are examined by a physician before receiving the drug and at 8, 16, and 24 weeks and are evaluated by the Global Acne Grading System. and Patients report side effects of isotretinoin. Lab tests will be requested at the beginning and 2 months of treatment. Photographs will be taken at the beginning and after 24 weeks and will be evaluated by two dermatologists who are not performing the project.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with moderate to severe acne, patients aged at least 15 years.
Exclusion criteria: Pregnant and lactating women, liver and kidney disorders; hyperlipidemia; a history of retinoid allergies; taking oral medication for acne for the past 2 months.
Intervention groups
All patients receive standard acne treatment, which includes isotretinoin 20 mg capsules daily, and one group, in addition to the above protocol, is treated with 5 mg des loratadine daily.
Main outcome variables
GAGS system score, number of inflammatory and non-inflammatory lesions, evaluation of side effects of isotretinoin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211010052723N1
Registration date:2021-11-18, 1400/08/27
Registration timing:prospective
Last update:2021-11-18, 1400/08/27
Update count:0
Registration date
2021-11-18, 1400/08/27
Registrant information
Name
Mahya Abedini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7745 1109
Email address
aabedini.ma@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-21, 1400/08/30
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral isotretinoin with isotretinoin and des loratadine in the treatment of moderate and severe acne vulgaris
Public title
Evaluation of the effect of desloratadine in the treatment of acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consent to participate in the study
Age over 15 years
No history of allergy to retinoid compounds
Do not take oral medications to treat acne for the past 2 months
Exclusion criteria:
liver or kidney disease and dyslipidemia
pregnancy or desire to get pregnant
breastfeeding
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The photograph will be evaluated by two non-executors dermatologists.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Evaluation of acne lesions before receiving the drug and at weeks 8, 16 and 24
Method of measurement
In the Global Acne Grading System 19 to 30 are considered moderate, 31-38 severe and above 38 very severe.
2
Description
Evaluation of the side effects of isotretinoin [dry skin, lips (Mild, moderate and severe), dry eyes, nosebleeds, and hair loss].
Timepoint
at weeks 8, 16 and 24
Method of measurement
Asking the patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients undergoing standard treatment for moderate to severe acne, including isotretinoin capsule (PHARMATHEN ACNOTREN) 20mg daily and clindamycin 1% solution (manufactured by Pak Drug factory) daily Patients with severe acne are also given azithromycin 250 mg by FATAK CHEMIE PARS daily for one month and receive 5 mg of desloratadine (neotadine produced by Abaidi factory) daily. Patients with severe and moderate disease severity are divided into two equal groups. Patients are treated for six months.
Category
Treatment - Drugs
2
Description
Control group: Patients undergoing standard treatment for moderate to severe acne, including isotretinoin capsule (PHARMATHEN ACNOTREN) 20mg daily and clindamycin 1% solution (manufactured by Pak Drug factory) daily Patients with severe acne are also given azithromycin 250 mg by FATAK CHEMIE PARS daily for one month. Patients with severe and moderate disease severity are divided into two equal groups. Patients are treated for six months.
Vice President for Research and Technology, Building No. 4,University of Esfahan, Hezar jerib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
http://research.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahya Abedini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 58, Madanian Ave, Behdari lashgar St, Artesh Blvr
City
Isfahan
Province
Isfehan
Postal code
8174755636
Phone
+98 31 3621 8308
Email
Aabedini.ma@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Asilian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Skin research center, sedigheh there hospital,khorram St, Jomhouri Sq
City
Isfahan
Province
Isfehan
Postal code
9819181876
Phone
+98 31 3335 9090
Email
Aabedini.ma@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahya Abedini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 58, Madanian Ave, Behdari lashgar St, Artesh Blv
City
Isfahan
Province
Isfehan
Postal code
8174755636
Phone
+98 31 3621 8308
Email
Aabedini.ma@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the study, study protocol, statistical analysis and clinical study report,the informed consent form, the codes used in the data analysis and the data dictionary can be shared with other researchers.
When the data will become available and for how long
Access period starts one month after the results are published
To whom data/document is available
Data will be available to researchers working in academic and scientific centers
Under which criteria data/document could be used
Researchers can use the findings and data of this study in their research by submitting a document that proves their employment in scientific and academic centers.
From where data/document is obtainable
Researchers can receive study data via sending an E-mail to researcher E-mail:Aabedini.ma@gmail.com phone number: 09128021807 Dr Mahya Abedini address: , Behdari lashgar Ave, Artesh Blv, Isfahan, Iran
What processes are involved for a request to access data/document
Researchers can send an email to the address to indicate the type of data they need, and after reviewing their request, the information will be sent to them via email.