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Comparison of the effectiveness of azithromycin capsules and zinc elemental capsules with azithromycin capsules alone in the treatment of mild to moderate acne vulgaris

Protocol summary

Study aim
Comparison of the effectiveness of azithromycin 250 mg capsule and zinc elemental 50 mg with azithromycin 250 mg capsule alone in the treatment of mild to moderate acne vulgaris.
Design
The clinical trial has two intervention groups, with parallel groups, double-blind, randomized, phase 2 on 60 patients.
Settings and conduct
A study on patients with mild to moderate acne vulgaris who referred to the skin clinic of Sinai Educational and Therapeutic Center, it will be done. Patients are randomly assigned to two groups of 30 people A and B. The first patient who meets the conditions for entering the study is in group A, the second patient is in group B, the third patient is in group A, and the fourth patient is in group B and so on. In order to avoid bias and prejudice and as a result to increase the accuracy and validity of the research, our study will be double-blind, so that the third person who is the pharmacist and will always be a specific pharmacist will know the composition of the drugs and both capsules It will be given to patients in a similar package. In group A, 250 mg azithromycin capsules will be prescribed once a day, and in the other group, 50 mg zinc elemental capsules will be prescribed once a day.
Participants/Inclusion and exclusion criteria
Patients suffering from mild to moderate acne vulgaris, aged 11-30 years and up to 20 inflammatory lesions on one side of the face, and the absence of nodules or cysts more than three on the same side of the face.
Intervention groups
In group A, 250 mg azithromycin capsules will be prescribed once a day, and in the other group, 50 mg zinc elemental capsules will be prescribed once a day.
Main outcome variables
Total acne Lesions Counting; Acne Severity Index; Severity; Side effects

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091012002581N12
Registration date: 2024-05-10, 1403/02/21
Registration timing: registered_while_recruiting

Last update: 2024-05-10, 1403/02/21
Update count: 0
Registration date
2024-05-10, 1403/02/21
Registrant information
Name
Hamide Herizchi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 4650
Email address
herizchih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of azithromycin capsules and zinc elemental capsules with azithromycin capsules alone in the treatment of mild to moderate acne vulgaris
Public title
Comparison of the effectiveness of azithromycin capsules and zinc elemental capsules with azithromycin capsules alone in the treatment of acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate acne aged 11-30 years Patients who have more than 20 inflammatory lesions (papules and pustules) on one side of the face and no more than three nodules or cysts on the same side of the face. Not having other skin diseases involving the face Having patient satisfaction Not having other systemic diseases aggravating acne, such as Cushing's syndrome, PCO, adrenal hyperplasia, acquired and innate immune deficiency, steroid acne and acneiform rashes, etc. Patients who have not used oral or topical anti-acne drugs in the last month, including natural and UV light and herbal and traditional acne treatments.
Exclusion criteria:
Patients who use topical or systemic steroids. Patients who use anti-androgen combinations. Patients who have used oral or topical anti-acne drugs even including natural light and UV in the last month. The presence of other facial skin dermatoses and other systemic diseases that aggravate acne, such as Cushing's syndrome, PCO, adrenal hyperplasia, acquired and innate immune deficiency, steroid acne and acneiform rashes, etc. Patient dissatisfaction The presence of more than three nodules or cysts on one side of the face Patients with excoriate acne Age below 11 years and above 30 years Having an inflammatory disease on the face other than acne, such as contact, allergic or seborrheic dermatitis, etc.
Age
From 11 years old to 30 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a simple way with individual randomization unit and using Rand List software. This assignment will be placed in a sealed envelope by someone independent of the study and will remain hidden until the end of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Our study will be double-blind, so that the attending physician and patients will not be informed of the type of drug combination received and the third person who is the pharmacist and will always be a specific pharmacist will know the composition of the drugs and both capsules It will be given to patients in a similar package.
Placebo
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
Vice Chancellor forresearch, 3rd floor, centural office, Tabriz Univercity of Medical Sciences, Golgasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Approval date
2024-02-27, 1402/12/08
Ethics committee reference number
IR.TBZMED.REC.1402.918

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
severity
Timepoint
Every 30 days
Method of measurement
History and clinical examination

Secondary outcomes

1

Description
patient satisfaction
Timepoint
every 30 days
Method of measurement
Questionnare

2

Description
total acne lesions
Timepoint
Every 30 days
Method of measurement
clinical examination

3

Description
index of acne severity
Timepoint
every 30 days
Method of measurement
clinical examination

Intervention groups

1

Description
Intervention group: Group A azithromycin capsule 250 mg once a day for month
Category
Treatment - Drugs

2

Description
Intervention group: Group B zinc elemental capsules 50 mg once a day for three months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Educational and treatment center of Sina
Full name of responsible person
Dr. Herizchi Hamide
Street address
Educational and treatment center of Sina
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Phone
+98 41 3637 0947
Email
herizchih@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Herizchi Hamide
Street address
Tabriz University of Medical Sciences, Gholghasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Phone
+98 41 3637 3944
Email
herizchih@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Dr. Hamide Herizchi
Position
Skin Disease Specialist / assistant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Tabriz University of Medical Sciences, Gholghasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Phone
+98 41 1336 4160
Email
herizchih@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Herizchi
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Tabriz University of Medical Sciences, Gholghasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Phone
+98 41 1336 4160
Email
herizchih@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Herizchi
Position
assistant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Tabriz University of Medical Sciences, Gholghasht st.
City
tabriz
Province
East Azarbaijan
Postal code
5159115705
Phone
+98 41 1336 4160
Email
herizchih@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
Study data is categorized and coded with no identifiable 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.
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