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Trial registered on ANZCTR


Registration number
ACTRN12619000073101
Ethics application status
Approved
Date submitted
11/01/2019
Date registered
18/01/2019
Date last updated
8/01/2020
Date data sharing statement initially provided
18/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Efficacy of Oral Azithromycin Versus Oral Doxycycline in the Treatment of Moderate Acne Vulgaris and Determination of the Effects of These Treatments on Patients' Quality of Life Among University Students.
Scientific title
Comparison of Efficacy of Oral Azithromycin Versus Oral Doxycycline in the Treatment of Moderate Acne Vulgaris and Determination of the Effects of These Treatments on Patients' Quality of Life Among University Students.
Secondary ID [1] 297048 0
Nill
Universal Trial Number (UTN)
nill
Trial acronym
nill
Linked study record
nill

Health condition
Health condition(s) or problem(s) studied:
moderate acne 311038 0
Condition category
Condition code
Skin 309682 309682 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
azithromycin capsules 500 mg once daily after food for 3 days , then 500 mg once a week after food (every Friday) for total of 12 weeks.
The prescription will be given in a monthly basis, each time the students will be asked about any remaining capsules.
Intervention code [1] 313324 0
Treatment: Drugs
Comparator / control treatment
100 mg tablet of doxycycline capsules once daily after food for 3 months.
Control group
Active

Outcomes
Primary outcome [1] 318650 0
The acne lesions before and after the treatment will be reported in the acne severity scale form.
Timepoint [1] 318650 0
The time point will be 3 months post treatments
Primary outcome [2] 318651 0
The Acne-specific Quality of Life Questionnaire (Acne-QoL) will be conducted and reported before and after the treatment in both groups
Timepoint [2] 318651 0
The time point will be 3 months post treatments
Secondary outcome [1] 365589 0
The reported side effects are:
1. Gastrointestinal disturbance (nausea, vomiting, abdominal pain)
2. Allergy to medications (skin rash)
The assessment of the side effects will be done by the treating physician during the monthly follow up
A chick list of the side effects for each participant will be filled during the monthly follow up visit by the treating physician


Timepoint [1] 365589 0
monthly for 3 months post treatment

Eligibility
Key inclusion criteria
university students diagnosed with moderate acne by Acne Severity Scale
Minimum age
17 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- Patients on antibiotics for other reasons in less than one month.
2- Pregnant ladies
3- Patients on topical anti-acne treatment
4- Patients with liver disease
5- Patients on topical or oral steroids
6- Patients on oral contraceptives

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
first the selected participant will be divided to 2 groups ( males and female )
then the Simple randomization by using coin-tossing will be allocated to intervention or control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nill
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size calculated to be 170 patients with 85 patients in each study arm to have 90% power to detect difference of a 25% of response treatment between the 2 antibiotics cohorts (25% to 50%) at the 5% alpha (significance) level. Because of missing data and losses to follow-up, an additional 30 subjects will be needed (100 in each arm) for a total of 200 subjects.

The data will be collected in hard copy with coding number for each participant. Then it will be entered in STATA version 13.1 for analysis. Descriptive statistics will be used to describe the data. For categorical variables, frequencies and percentages will be reported. Differences between groups will be analysed using Pearson’s c2 tests. For continuous variables, mean and standard deviation will be used to present the data while analysis will be performed using Student’s t-tests. For non-normal distributed continuous variables, median and interquartile range (IQR) will be used to summarize the data and analysis performed using Wilcoxon-Mann-Whitney tests. An a priory two-tailed level of significance will be set at <0.05 level.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21192 0
Oman
State/province [1] 21192 0
Muscat

Funding & Sponsors
Funding source category [1] 301617 0
University
Name [1] 301617 0
Sultan Qaboos University
Address [1] 301617 0
College of medicine
Dept. of Family Medicine and Public Health
P.O. Box 35, Al-Khoudh
P.C. 123 Sultanate of Oman
Country [1] 301617 0
Oman
Primary sponsor type
University
Name
Sultan Qaboos University
Address
College of medicine
Dept. of Family Medicine and Public Health
P.O. Box 35, Al-Khoudh
P.C. 123 Sultanate of Oman
Country
Oman
Secondary sponsor category [1] 301320 0
None
Name [1] 301320 0
Address [1] 301320 0
Country [1] 301320 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302343 0
medical research ethical committee -college of medicine -SQU
Ethics committee address [1] 302343 0
College of medicine
medical research ethical committee
P.O. Box 35, Al-Khoudh
P.C. 123 Sultanate of Oman
Ethics committee country [1] 302343 0
Oman
Date submitted for ethics approval [1] 302343 0
25/01/2019
Approval date [1] 302343 0
02/06/2019
Ethics approval number [1] 302343 0
1914

Summary
Brief summary
An open label randomised controlled trial which will be conducted in student clinic and comparing the efficacy of oral azithromycin and oral doxycycline on moderate acne plus it will see the difference in quality of life scale in both groups before and after treatment. A total of 200 moderate acne patients, males and females, will be included in the study, 100 patients in each arm. The gender and age will be distributed equally between the two groups. They will be followed for 3 months with an assessment in the improvement in acne severity scale every month from the start of the study. The response to treatment will be assessed by using the difference in acne severity scale before treatment and after 3 months of treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89894 0
Dr Asma AL Shidhani
Address 89894 0
sultanate of Oman
Sultan Qaboos University
department of family medicine and public health
Al Khoudh
PO Box 35
postcode 123

Country 89894 0
Oman
Phone 89894 0
0096899425859
Fax 89894 0
Email 89894 0
asmash@squ.edu.om
Contact person for public queries
Name 89895 0
Dr Asma AL Shidhani
Address 89895 0
sultanate of Oman
Sultan Qaboos University
department of family medicine and public health
Al Khoudh
PO Box 35
postcode 123

Country 89895 0
Oman
Phone 89895 0
0096899425859
Fax 89895 0
Email 89895 0
asmash@squ.edu.om
Contact person for scientific queries
Name 89896 0
Dr Asma AL Shidhani
Address 89896 0
sultanate of Oman
Sultan Qaboos University
department of family medicine and public health
Al Khoudh
PO Box 35
postcode 123

Country 89896 0
Oman
Phone 89896 0
0096899425859
Fax 89896 0
Email 89896 0
asmash@squ.edu.om

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
age , gender, change in acne severity scale , change in quality of life index and if any reported side effects
When will data be available (start and end dates)?
from 1/ 5/2020 until 1/12/2020
Available to whom?
researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator,
What supporting documents are/will be available?
Other
'Other' documents specified
Acne-specific Quality of Life Questionnaire (Acne-QoL) Manual & Interpretation Guide
How or where can supporting documents be obtained?
Type [1] 1038 0
Other
Citation [1] 1038 0
Link [1] 1038 0
Email [1] 1038 0
Other [1] 1038 0
the Ethics application
Type [2] 1039 0
Other
Citation [2] 1039 0
Link [2] 1039 0
Email [2] 1039 0
Other [2] 1039 0
Acne-specific Quality of Life Questionnaire (Acne-QoL)
Manual & Interpretation Guide
Summary results
No Results