Comparing the effectiveness of spironolactone 5% solution with clindamycin 2% solution in patients with mild to moderate acne vulgaris in Tabriz.
Design
Uncontrolled, parallel-group, single-blind, randomized, phase 2 clinical trial on 60 patients. Randlist software was used for randomization.
Settings and conduct
Place of study: Dermatology Clinic of Sina Hospital, Tabriz; Study population: 60 patients with mild to moderate acne; Type of blinding: single blind; Method of blinding: The person evaluating the treatment will not know the allocation of the intervention in the groups until the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criterion: patients suffering from mild to moderate acne vulgaris. Exclusion criteria: allergy and sensitivity to the drugs used in the study; worsening of the lesions; suffering from diseases that cause acne and medicinal acne; severe cases of acne (cases of nodules and cysts); use of anti-acne treatment in the last 4 weeks; pregnancy
Intervention groups
Intervention group (Spironolactone): patients received spironolactone 5% hydrolyzate solution locally on acne lesions and one centimeter around the lesion. Control group: patients received clindamycin hydroalcoholic 2% solution locally on acne lesions and one centimeter around the lesion.
Main outcome variables
Total acne Lesions counting؛ Acne Severity Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120524009844N12
Registration date:2024-06-18, 1403/03/29
Registration timing:prospective
Last update:2024-06-18, 1403/03/29
Update count:0
Registration date
2024-06-18, 1403/03/29
Registrant information
Name
Mehdi Amirnia
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
amirniam@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of spironolactone 5% solution with clindamycin 2% solution in patients with mild to moderate acne vulgaris
Public title
Comparing the effectiveness of spironolactone solution with clindamycin solution in patients with acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate acne vulgaris
Age 15 to 35 years
Exclusion criteria:
Allergy and sensitivity to the drugs used in the study
worsening of lesions
suffering from diseases that cause acne and medicinal acne
severe cases of acne (cases of nodules and cysts)
use of anti-acne treatment in the last 4 weeks
pregnancy
Age
From 15 years old to 35 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization will be carried out on an individual basis by RandList software. The selection of patients will be based on sealed envelopes that be written A and B inside them. 60 envelopes will be prepared in two groups. After entering the clinic and before the visit, patients will receive the envelope from the secretary and hand it over to the physician.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is a single-blind study and the initial examination of the patients and the resulting changes after prescribing the drugs will be done by the assistant every 2 weeks. The treatment evaluator, who is outside the study, will not be informed of the intervention allocation in the groups until the end of the study, and will not have any information about the ongoing study and interventions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Third floor, Central Building No.2, Tabriz University of Medical Sciences, Gholgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Approval date
2023-11-25, 1402/09/04
Ethics committee reference number
IR.TBZMED.REC.1402.627
Health conditions studied
1
Description of health condition studied
Mild to moderate acne vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Total acne Lesions counting
Timepoint
Once every four weeks
Method of measurement
Clinical examination and observation
2
Description
Acne Severity Index
Timepoint
Once every four weeks
Method of measurement
Clinical examination and observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group will be treated with a spironolactone 5% solution topically on acne lesions up to a distance of one centimeter around the lesion for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: The second group will be treated with clindamycin hydroalcoholic 2% solution topically on acne lesions up to a distance of one centimeter around the lesion for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Department of Sina Hospital, Tabriz University of Medical Sciences.
Full name of responsible person
Elnaz Poorhasani
Street address
Sina Hospital, Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
mehamir46@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Vice Chancellor for Research, Central Building of Tabriz University of Medical Sciences, Daneshgah Square
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3336 4667
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Amirnia
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 1540 6612
Fax
+98 41 1540 6612
Email
amirniam@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Amirnia
Position
Proferssor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 1540 6612
Fax
+98 41 1540 6612
Email
amirniam@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Amirnia
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 1540 6612
Fax
+98 41 1540 6612
Email
amirniam@tbzmed.ac.ir
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
No - There is not 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
The study data are classified and coded so that the names of the individuals cannot be identified. Access to all the study data will be possible except for the identifying information of the individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The request will be sent by email to person responsible for scientific or public inquiries.