Determining and comparing the effect of using oral isotretinoin and loratadine with oral isotretinoin in the treatment of moderate to severe acne vulgaris.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3, on 70 patients.
Settings and conduct
The current research is a randomized clinical trial. whose statistical population consists of patients diagnosed with acne vulgaris who referred to the skin clinic of Sinai Hospital in Hamedan in the years 1401 to 1402. Patients who met the conditions for entering the study will be interviewed after completing the consent form and all patient information such as age, gender, acne severity score, number of lesions and type of skin lesions will be recorded in the checklist. Patients will be randomly classified into two treatment groups in such a way that in terms of disease severity, age and gender are equally distributed in both groups. In order to avoid bias in this study, the researcher and the patient do not know the type of drug assigned and the study is conducted in a double-blind manner.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
People with moderate to severe acne
Exclusion criteria:
Age less than 18 years, pregnant and lactating women or women who plan to become pregnant in the near future (due to the teratogenicity of isotretinoin), people with systemic diseases
Intervention groups
the first group (A): treatment with isotretinoin capsule 20 mg once daily after lunch and loratadine 10 mg tablet at night before going to sleep for 12 weeks.
The second group (B): treatment with isotretinoin capsules 20 mg daily after meals and placebo tablets at night before sleep for 12 weeks.
Main outcome variables
Number of acne lesions after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220705055374N1
Registration date:2022-07-11, 1401/04/20
Registration timing:prospective
Last update:2022-07-11, 1401/04/20
Update count:1
Registration date
2022-07-11, 1401/04/20
Registrant information
Name
Forough Eftekhari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 937 054 4655
Email address
forough.eftekhari8@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative of the effect of oral isotretinoin and loratadin with oral isotretinoin in the treatment of moderate to severe acne vulgaris patients
Public title
Comparative of the effect of oral isotretinoin and loratadin with oral isotretinoin in the treatment of moderate to severe acne vulgaris patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with moderate to severe acne
Exclusion criteria:
Age<18 years
Pregnant and lactating female
Systemic disease
Concurrent use of other acne therapies
Other dermatological condition requiring interfering treatment
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: The number of samples allocated to each of the studied groups is equal, so that the intervention group includes 35 people and the control group also includes 35 people. 35 balls for the intervention group and 35 balls for the control group are drawn in a container. and then the balls are randomly removed from the container without replacement and the created sequence is recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Loratadine tablets and placebo tablets will be prepared in the same sealed envelopes so that neither the researcher nor the patient will know the type of drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Khawaja Rashid Crossroad - Beginning of Ayatollah Kashani Blvd - University of Medical Sciences and Health Services of Hamedan Province
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2022-06-27, 1401/04/06
Ethics committee reference number
IR.UMSHA.REC.1401.319
Health conditions studied
1
Description of health condition studied
Acne vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Number of acne lesions after treatment
Timepoint
At baseline and at weeks 4, 8 and 12 after treatment
Method of measurement
Observe and record in the checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment with isotretinoin capsule 20 mg once daily after lunch and Loratadine 10 mg tablet at night before sleep for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Treatment with isotretinoin capsules 20 mg daily after meals and placebo tablets at night before sleep for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Forough Eftekhari
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd.,Pajoohesh squareedan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 0572
Email
forough.eftekhari8@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd.,Pajoohesh square
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
forough.eftekhari8@gmail.com
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
Forough Eftekhari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd.,Pajoohesh square
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
forough.eftekhari8@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Bahareh Ebrahimi
Position
Asistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd.,Pajoohesh square
City
Hamedan
Province
Hamadan
Postal code
6516737157
Phone
+98 81 3131 0000
Fax
Email
b.ebrahimi.4362@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Forough Eftekhari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
No.78 , Rahemi Ave Bahmani Str
City
Hamedan
Province
Hamadan
Postal code
6516737157
Phone
+98 937 054 4655
Fax
Email
forough.eftekhari8@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
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