Comparison of the effect of 40% salicylic acid versus 30% salicylic acid with and without combination with doxycycline in the treatment of moderate acne vulgaris: a double-blinded, randomized, clinical trial
effect of salicylic acid 40% compared to 30% salicylic acid with and without combination with doxycycline in the treatment of moderate acne vulgaris
Design
A double-blind, phase 1 clinical trial with 99 patients will be performed for randomization by permutation blocks with variable size of three and six, and after preparing a list of individuals using web-based randomization, from opaque envelopes will be sealed. And waxed is used by other researchers to hide the randomization process.
Settings and conduct
Research population: Patients with moderate acne vulgaris referred to the dermatology clinic of Allameh Behlool Gonabadi Hospital during the study period
Individuals referring to dermatology clinics will be divided into three intervention groups 1, 2, 3 and 3 if they have the conditions to enter the study after the company's consent.
Assessments will be determined by your doctor at the beginning of treatment and then every two weeks until the end of treatment and one month after the end of treatment.
Participants/Inclusion and exclusion criteria
Entry requirements:
Moderate to severe acne vulgaris (according to the classification system of vampires)
• Age over 12 years
No entry conditions:
• Pregnancy or intending to
• Breastfeeding
Taking oral and topical acne medications in the last 30 days
• History of allergies to drugs used in the study
• History of colloid formation
• History of light sensitivity
• Presence of recurrent herpes simplex infection
• The presence of warts on the face and contagious molluscum in patients
• Active dermatitis on the face
Intervention groups
The first group: recipients of 30% salicylic acid and doxycycline
The second group: recipients of 30% salicylic acid and placebo
Group 3: Recipients of 40% salicylic acid and placebo
Main outcome variables
Improve vulgaris acne
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211102052949N1
Registration date:2021-12-20, 1400/09/29
Registration timing:registered_while_recruiting
Last update:2021-12-20, 1400/09/29
Update count:0
Registration date
2021-12-20, 1400/09/29
Registrant information
Name
Abolfazl Mokhtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5729 2003
Email address
abolfazl.mokhtari1997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-29, 1400/09/08
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 40% salicylic acid versus 30% salicylic acid with and without combination with doxycycline in the treatment of moderate acne vulgaris: a double-blinded, randomized, clinical trial
Public title
Salicylic acid in acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate acne vulgaris(according to Vaishampayan classification)
Age greater than 12 years
Exclusion criteria:
Pregnancy or intending to
Breastfeeding
Taking oral and topical acne medications in the last 34 day
History of allergies to the drugs used in the study
History of light sensitivity
Existence of recurrent herpes simplex infection
Presence of warts on the face and contagious molluscum in patients
Active dermatitis on the face
Having gastrointestinal disorders (especially esophagitis and gastroesophageal reflux)
History of liver and kidney diseases
Age
From 12 years old to 40 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
At first, people who have the Word criterion to study, after obtaining the consent of the company to study based on the selected goal, then people will be divided into three groups of intervention 1, 2 and control in the form of glass permutation blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and analysts will be unaware of the allocation of individuals to treatment groups.
Prior to sampling, participants will be asked not to confuse the treatment method with other people, and also to note the treatment for individuals so that the samples have the least contact with each other.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Khorasan Razavi, Gonabad, Imam Khomeini St., Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Approval date
2021-02-06, 1399/11/18
Ethics committee reference number
IR.GMU.REC.1399.114
Health conditions studied
1
Description of health condition studied
Acne vulgaris
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
acne vulgaris
Timepoint
Observation of the number and type of facial acne vulgaris before the intervention and 12 weeks after the intervention and also one month after the intervention
Method of measurement
system Vaishampayan, Standard Photography, Michelson Acne Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Intervention group: Patients are first examined by a dermatologist to measure the severity of their acne based on Michelson's acne score, and patients undergo standard photography. Then (recipients of 30% salicylic acid and doxycycline) treatment for 12 weeks with doxycycline 100 mg daily and peeling 30% salicylic acid will be done every two weeks. Then, once every two weeks until the end of treatment and also one month after the end of treatment, acne severity will be assessed based on Michelson's acne score, patient satisfaction, improvement based on the doctor's opinion and examination based on photography.
Category
Treatment - Drugs
2
Description
IPatients are first examined by a dermatologist to measure the severity of their acne based on Michelson's acne score, and patients undergo standard photography. Then (recipients of 40% salicylic acid and doxycycline placebo) treatment for 12 weeks with daily doxycycline placebo and 40% salicylic acid peeling will be performed every two weeks. Then, once every two weeks until the end of treatment and also one month after the end of treatment, acne severity will be assessed based on Michelson's acne score, patient satisfaction, improvement based on the doctor's opinion and examination based on photography.
Category
Treatment - Drugs
3
Description
Control group: Control group: At first, patients are examined by a dermatologist. The severity of their acne is measured based on Michelson's acne score and patients undergo standard photography. Then (recipients of 30% salicylic acid and doxycycline placebo) treatment for 12 weeks with doxycycline placebo Daily and 30% salicylic acid peeling will do once every two weeks. Then, once every two weeks until the end of treatment and also one month after the end of treatment, acne severity will be assessed based on Michelson's acne score, patient satisfaction, improvement based on the doctor's opinion and examination based on photography.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh bohlool hospital
Full name of responsible person
Hamideh Mohammadzadeh
Street address
Bohlol Hospital, Parastar Boulevard, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۷۸۵۲_۹۶۹۱۷
Phone
+98 51 5723 6832
Email
Mohammadzadeh.hamideh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Shahla Khosravan
Street address
Gonabad Medical Univercity, Mehdizadeh Boulevard, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۷۸۵۲_۹۶۹۱۷
Phone
+98 51 5722 3028
Email
Mohammadzadeh.hamideh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Hamideh Mohammadzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Bohlol Hospital, Parastar Boulevard, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۷۸۵۲_۹۶۹۱۷
Phone
+98 51 5723 6832
Email
Mohammadzadeh.hamideh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Hamideh mohammadzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Bohlol Hospital, Parastar Boulevard, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۷۸۵۲_۹۶۹۱۷
Phone
+98 51 5723 6832
Email
Mohammadzadeh.hamideh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Hamideh Mohammadzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Bohlol Hospital, Parastar Boulevard, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۷۸۵۲_۹۶۹۱۷
Phone
+98 51 5723 6832
Email
Mohammadzadeh.hamideh@yahoo.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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data will be provided to researchers without names and details.
When the data will become available and for how long
After completing the design and printing of the article
To whom data/document is available
All researchers and pharmaceutical companies
Under which criteria data/document could be used
For similar research, the officials of pharmaceutical companies can access the results of the project by referring to the research vice chancellor of Gonabad University of Medical Sciences with the written consent of the vice chancellor for research.
From where data/document is obtainable
Vice Chancellor for Research, Gonabad University of Medical Sciences
What processes are involved for a request to access data/document
Researchers can access the results of the project by referring to the Vice Chancellor for Research of Gonabad University of Medical Sciences with the written consent of the Vice Chancellor for Research.