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Trial registered on ANZCTR


Registration number
ACTRN12622001578796
Ethics application status
Approved
Date submitted
9/10/2022
Date registered
20/12/2022
Date last updated
20/12/2022
Date data sharing statement initially provided
20/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Association Of Serum Lipid Profile With Acne Vulgaris In Pakistani Population
Scientific title
Association Of Serum Lipid Profile With Acne Vulgaris In Pakistani Population
Secondary ID [1] 308048 0
Nil known
Universal Trial Number (UTN)
U1111-1283-0312
Trial acronym
SLAV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne vulgaris 327739 0
Lipid profile including Total Cholesterol (TC) , Triglycerides (TG), High density lipoprotein Cholesterol (HDL- C) , Low density lipoprotein Cholesterol (LDL-C) , Total cholesterol to High density lipoprotein- Cholesterol ratio ( TC/HDL-C ratio) 327740 0
Condition category
Condition code
Skin 324809 324809 0 0
Dermatological conditions
Metabolic and Endocrine 324810 324810 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Serum lipid levels
Serum lipid profiles will be tested at presentation only once after an overnight fast of 12 hours to quantify total cholesterol (TC), HDL-C, LDL-C, and triglycerides (TG). The lipid profile will be done on Atellica system using photometric principle. Serum LDL will be estimated using Friedewald's formula The normal ranges for the serum lipid profile are based on the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III)
Dyslipidemia: National Cholesterol Education Programme (NCEP) guidelines 11 will be
used for definition of dyslipidemia as follows
Total Cholesterol normal range <5 2 mmol/L . Hypercholesterolemia serum
cholesterol levels greater than or equal to 200 mg/dl (greater than or equal to 5.2 mmol/l)
Triqlvcerides normal range <150 mg/dl Hypertriglyceridemia - serum triglyceride levels
greater than or equal to 150 mg/dl (greater than or equal to 1.7 mmol/l)
HDL-C normal range HDL cholesterol levels >40 mg /dl low HDL lesser than 40 mg/dl (lesser than 1.04 mmol/l)
LDL-C normal range LDL cholesterol levels <130mg/dl Raised serum LDL -C greater than or equal to 130 mg/dl (greater than or equal to 3.4 mmol/l) calculated using the Friedewald equation
High total cholesterol to HDL-C ratio A TC/HDL-C ratio raised beyond 4.0 will be
characterized as a marker of deranged lipid profile

Cases with clinical findings of acne vulgaris will be graded according to Global Acne Grading System Score (GAGS score) into mild moderate and severe acne on their visit to outpatient department
Intervention code [1] 324496 0
Early Detection / Screening
Comparator / control treatment
Age and gender matched individuals presenting to Dermatology outpatient
department of Pak Emirates Military Hospital who do not have acne vulgaris including
1. Attendants of patients
2. Hospital workers including paramedical staff, ward boys, Janitors
Control group
Active

Outcomes
Primary outcome [1] 332630 0
Acne vulgaris
Comedone :A skin-coloured, raised lesion formed try a plug of keratin and sebum in a dilated pilosebaceous orifice open comedones are blackheads, closed comedones are whiteheads.
Papule: A painful raised inflammatory lesion that does not contain pus and measures < 1cm
Pustule : A circumscribed inflammatory lesion that contains purulent material
Nodule : An elevated solid palpable lesion in the dermis or subcutis > 1 cm
Global Acne Grading System score is calculated as follows
Location Factor
Forehead 2, Left cheek 2, Right cheek 2, Chin 1, Nose 1, Chest and upper back 3,

Each type of lesion is given a value depending on severity:
No lesions=O, comedones=1, papules=2, pustules=3 and nodules=4

The score for each area (Local score) = Factor x grade

The global score is the sum of local scores and acne severity is graded using the global score

Mild Acne : GAGS score 1 - 18

Moderate acne : GAGS score 19-30

Severe Acne : GAGS score 31 -38

Verv severe Acne : GAGS score >39
Timepoint [1] 332630 0
At the time of presentation in clinic
Primary outcome [2] 333080 0
Serum lipid profile
Serum lipid profiles will be tested after an overnight fast of 12 hours to quantify total cholesterol (TC), HDL-C, LDL-C, and triglycerides (TG). The lipid profile will be done on Atellica system using photometric principle. Serum LDL will be estimated using Friedewald's formula The normal ranges for the serum lipid profile are based on the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) ,definition of dyslipidemia will be as follows:

Total Cholesterol normal range <5.2 mmol/L .Hypercholesterolemia – serum cholesterol levels >200 mg/dl (>5.2 mmol/l)

Triglycerides normal range <150 mg/dl Hypertriglyceridemia – serum triglyceride levels >150 mg/dl (>1.7 mmol/l).

HDL-C normal range HDL cholesterol levels >40 mg /dl , low HDL <40 mg/dl (<1.04 mmol/l).

LDL-C normal range LDL cholesterol levels <130mg/dl. Raised serum LDL-C >130 mg/dl (>3.4 mmol/l) calculated using the Friedewald equation.

High total cholesterol to HDL-C ratio: A TC/HDL-C ratio raised beyond 4.0 will be characterized as a marker of deranged lipid profile.
Timepoint [2] 333080 0
At the time of presentation
Secondary outcome [1] 414598 0
Nil
Timepoint [1] 414598 0
Nil

Eligibility
Key inclusion criteria
Individuals of both sexes with age > 12 years who are not taking treatment for acne vulgaris presenting to the Dermatology outpatient department of Pak Emirates Military Hospital, will be recruited as cases.
Controls: Age and gender matched individuals presenting to Dermatology outpatient department of Pak Emirates Military Hospital including
1. Attendants of patients
2. Hospital workers including paramedical staff, ward boys, janitors.
Minimum age
12 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cases
1. Diabetes mellitus
2. PCOS
3. Obesity (BMI greater than or equal to 30)
4. Individuals who are taking oral isotretinoin and those who have taken isotretnoin in previous 6 months
5. Alcohol consumption
6. Acne caused by use of steroids
7. Individuals taking antihyperlipidemic drugs
8. Individuals taking oral contraceptives
9. Pregnant women
10. Lactating women
Controls
1. Diabetes mellitus
2. PCOS
3. Obesity (BMI greater than or equal to 30)
4. Individuals who are taking oral isotretinoin and those who have taken isotretnoin in previous 6 months
5. Alcohol consumption
6. Individuals taking steroids
7. Individuals taking antihyperlipidemic drugs
8. Individuals taking oral contraceptives
9. Pregnant women
10. Lactating women

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Considering Acne vulgaris as the outcome of interest and keeping 5% level of significance, 80% power of study sample size was calculated using WHO calculator
Population proportion for group 1= 45.34%
Population proportion for group 2= 30%
The estimated sample size came out to be 250 individuals. A total of 125 patients with acne vulgaris will be recruited, and will be compared with age and gender-matched healthy controls (n = 125).

The data will be analysed by using SPSS version 23. Frequency and percentages will be calculated for qualitative variables like gender mild,moderate and severe acne. Mean and standard deviation will be calculated for quantitative variables like age, BMI, GAGS score, TC, HDL-C, LDL-C ,TG and TC: HDL. Inferential statistics will be applied to find association between variables of interest. The lipid profiles of cases versus controls will be evaluated by using chi-square test. Odds ratio will be calculated to determine the association between acne and hyperlipidemia. Moreover, effect modifiers like age, gender and BMI will be stratified by using post stratified chi-square test. The p value < 0.05 will be considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/12/2022
Actual
Date of last participant enrolment
Anticipated
22/06/2023
Actual
Date of last data collection
Anticipated
22/06/2023
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 25050 0
Pakistan
State/province [1] 25050 0
Punjab

Funding & Sponsors
Funding source category [1] 312304 0
Hospital
Name [1] 312304 0
Pak Emirates Military Hospital
Country [1] 312304 0
Pakistan
Primary sponsor type
Individual
Name
Farah Bano
Address
Pak Emirates Military Hospital, Abid Majeed Rd, Rawalpindi, Punjab 46000
Country
Pakistan
Secondary sponsor category [1] 313971 0
None
Name [1] 313971 0
Address [1] 313971 0
Country [1] 313971 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311673 0
Ethical Committee Pak Emirates Military Hospital
Ethics committee address [1] 311673 0
Pak Emirates Military Hospital, Abid Majeed Rd, Rawalpindi, Punjab 46000
Ethics committee country [1] 311673 0
Pakistan
Date submitted for ethics approval [1] 311673 0
10/10/2022
Approval date [1] 311673 0
30/11/2022
Ethics approval number [1] 311673 0
A/28/EC/469/2022

Summary
Brief summary
Data will be collected after the approval of hospital ethical review committee. Verbal consent for inclusion in the study will be taken from the patients.
Cases with clinical findings of acne vulgaris will be graded according to GAGS score into mild moderate and severe acne. Serum lipid profiles will be tested after an overnight fast of 12 hours to quantify total cholesterol (TC), HDL-C, LDL-C, and triglycerides (TG). The lipid profile will be done on Atellica system using photometric principle. Serum LDL will be estimated using Friedewald's formula The normal ranges for the serum lipid profile are based on the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) .Data will be entered on data collection proforma .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121946 0
Dr Farah Bano
Address 121946 0
Pak Emirates Military Hospital, Abid Majeed Rd, Rawalpindi, Punjab 46000
Country 121946 0
Pakistan
Phone 121946 0
+923359552528
Fax 121946 0
Email 121946 0
farahbano89@gmail.com
Contact person for public queries
Name 121947 0
Dr Farah Bano
Address 121947 0
Pak Emirates Military Hospital, Abid Majeed Rd, Rawalpindi, Punjab 46000
Country 121947 0
Pakistan
Phone 121947 0
+923359552528
Fax 121947 0
Email 121947 0
farahbano89@gmail.com
Contact person for scientific queries
Name 121948 0
Dr Farah Bano
Address 121948 0
Pak Emirates Military Hospital, Abid Majeed Rd, Rawalpindi, Punjab 46000
Country 121948 0
Pakistan
Phone 121948 0
+923359552528
Fax 121948 0
Email 121948 0
farahbano89@gmail.com

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
BMI
Acne Global score (GAGS score)
Acne severity :Mild / Moderate / Severe / Very Severe
Plasma lipid profile:
Total cholesterol
LDL-C
HDL-C
Triglycerides
Total cholesterol : HDL
When will data be available (start and end dates)?
23 December 2022 to 22 June 2023
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
The data will be analysed by using SPSS version 23.
Frequency and percentages
Mean and standard deviation
Inferential statistics will be applied to find association between variables of interest.
Chi- Square test
odds ratio
post stratification Chi- Square test
How or where can data be obtained?
Dermatology Outpatient Department Pak Emirates Military Hospital, Abid Majeed Rd, Rawalpindi, Punjab 46000
Pathology laboratory Pak Emirates Military Hospital, Abid Majeed Rd, Rawalpindi, Punjab 46000


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.