A comparative study of 5% dapsone gel with 0.1% adapalene gel in patients with acne vulgaris
Design
A clinical trial without a control group, community-based and practice-oriented, parallel groups, double-blind, randomized, phase 3 on 60 patients (30 receiving dapsone and 30 receiving adapalene). A simple randomization method was used for randomization.
Settings and conduct
To investigate the effectiveness of dapsone gel in acne and compare its effect with adapalene gel, patients diagnosed with acne vulgaris with moderate to severe severity who refer to the skin clinic of Imam Khomeini Hospital in Ahvaz are randomly divided into two groups. become The first group will receive dapsone gel and the second group will receive adapalene gel. To check the severity of acne, the criterion of the global acne grading system is used. Also, the study is conducted in a double-blind manner (patient and interventionist) so that the gel inside the same container will be given to the patients by a non-interventionist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with moderate to severe inflammatory acne on the face, at least 12 years old.
Exclusion criteria: lactating and pregnant women, people who have received topical and systemic anti-acne treatment within the previous month, cases of mild acne, and a history of allergy to doxycycline, adapalene, and dapsone.
Intervention groups
First group: treatment with 5% dapsone gel twice a day for 2 months. Second group: treatment with 0.1% adapalene gel twice a day for 2 months
Main outcome variables
Number of acne lesions after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230806059062N1
Registration date:2023-08-20, 1402/05/29
Registration timing:prospective
Last update:2023-08-20, 1402/05/29
Update count:0
Registration date
2023-08-20, 1402/05/29
Registrant information
Name
Kosar Gholipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 114 3709
Email address
gholipour.k@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of Dapsone gel 5% with Adapalene gel 0.1% in patients with acne vulgaris
Public title
Effect of Dapsone gel 5% in the treatment of patients with acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate to severe inflammatory acne on the face
Exclusion criteria:
Pregnant and lactating women
History of using systemic anti-acne treatment drugs in the previous 1 month
The presence of inflammatory acne on the trunk without facial involvement
Cases of mild acne (the presence of only comedones without inflammatory lesions)
Photosensitivity
Patients receiving drugs that cause photosensitivity (such as griseofulvin).
Age above 30 years and below 12 years
Patients with G6pd deficiency (in the group receiving dapsone gel)
History of allergy to doxycycline, adapalene and dapsone
Age
From 12 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with eligibility criteria will be divided into two groups using a randomized block design. An online website (https://www.sealedenvelope.com) is used to generate a random list based on the desired sample size and block size of 4. After creating a list, each patient will identify with a unique code throughout the study.
30 people are selected for the first intervention group and 30 people for the second intervention group. Then, each number is written on the drug container, which is the same for both groups, and it will be given to the patients by someone other than the interventionist, while the patients are not aware of the contents of the container.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be evaluated by another specialist as part of the main researcher, and the design will be done in a double-blind manner. Medicines are provided to patients in a sealed container by a non-interventionist who is the same for both groups, so that patients will not know about its contents due to the similarity of the two types of gel.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan Hospital Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan blvd- Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2023-05-09, 1402/02/19
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1402.030
Health conditions studied
1
Description of health condition studied
Acne
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Acne severity based on the global acne grading system
Timepoint
Before starting treatment, 1, 2 and 3 months after starting treatment
Method of measurement
Global acne grading system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment with 5% dapsone gel (Pars Behrouzan Jam Company) twice a day for 2 months
Category
Treatment - Drugs
2
Description
Intervention group: Treatment with Adapalene gel 0.1 % (Razak Company) twice a day for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini
Full name of responsible person
Kosar Gholipour
Street address
Azadegan St. - Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3314 0000
Email
gholipour.k@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Ahvaz, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3314 0000
Email
zakerkish-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Kosar Gholipour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Azadegan St. - Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3314 0000
Email
gholipour.k@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kosar Gholipour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Azadegan St. - Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3314 0000
Fax
Email
gholipour.k@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kosar Gholipour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Azadegan St. - Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3314 0000
Email
gholipour.k@ajums.ac.ir
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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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