Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000983404
Ethics application status
Approved
Date submitted
18/04/2025
Date registered
5/09/2025
Date last updated
5/09/2025
Date data sharing statement initially provided
5/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the therapeutic efficacy of oral low dose versus pulsed dose oral isotretinoin in moderate acne vulgaris patients presenting in PNS Shifa Hospital, Karachi
Scientific title
Comparing the therapeutic efficacy of oral low dose versus pulsed dose oral isotretinoin in moderate acne vulgaris patients presenting in PNS Shifa Hospital, Karachi
Secondary ID [1] 314024 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne vulgaris 336764 0
Condition category
Condition code
Skin 333255 333255 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be divided into two groups. Group A will receive low dose isotretinoin 20 mg oral capsule daily and Group B will receive pulsed dose of 1 mg/kg/day oral capsule for 1 week in the whole month( 4 weeks). Patients assigned to either groups using the sequential method. Patients will receive treatment for 6 months. All the patients will be provided with the same brand of medicine to minimize brand bias. Primary endpoint will be photographic score at the end of 6 months from baseline. Standardized digital photographs of the acne affected area will be taken every month with the patient in a similar position to ensure consistency of photography. Treatment response will be evaluated on a standardized 4-point rating scale calculated at the end of 6 months following completion of treatment , as indicated with help of ( annexure C ) - Global Acne Grading System.
0 = completely cleared (100% improved from baseline Acne severity index),
1 = marked improvement ( > 75% improved from baseline Acne severity index),
2 = moderate improvement ( 50–75% improved from baseline Acne severity index),
3 = mild improvement ( 25-50% improved from baseline Acne severity index ),
4 = insignificant improvement ( <25% improved from baseline Acne severity index) .. Safety evaluations will be done on monthly visits by asking patients about any adverse effects related to medication. Baseline investigations using CBC, LFT, lipid profile and urine pregnancy test ( females of child bearing age ) will be done before starting treatment and follow up investigations at end of first, third and sixth month of treatment. Female participants will get treatment only after their next menstrual period to ensure that they are not pregnant at time of treatment initiation. The participants were also followed up for 8 months after completion of treatment to look for any relapse.
Intervention code [1] 330601 0
Treatment: Drugs
Comparator / control treatment
Group A who will receive low dose isotretinoin 20 mg daily.
Control group
Dose comparison

Outcomes
Primary outcome [1] 340820 0
Treatment response will be evaluated on a standardized 4-point rating scale calculated at the end of 6 months following completion of treatment , as indicated with help of ( annexure C ) - Global Acne Grading System. 0 = completely cleared (100% improved from baseline Acne severity index), 1 = marked improvement ( > 75% improved from baseline Acne severity index), 2 = moderate improvement ( 50–75% improved from baseline Acne severity index), 3 = mild improvement ( 25-50% improved from baseline Acne severity index ), 4 = insignificant improvement ( <25% improved from baseline Acne severity index)
Timepoint [1] 340820 0
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks after commencing dosage
Secondary outcome [1] 445169 0
Safety evaluations will be done on monthly visits by asking patients about any adverse effects related to medication
Timepoint [1] 445169 0
Baseline, 4 weeks, 8 weeks, 12 weeks , 16 weeks, 20 weeks and 24 weeks after commencing dosage

Eligibility
Key inclusion criteria
1. Non pregnant females , unmarried females , not planning conception for 2 years
2. Both female and male
3. Age above 12 years willing to undergo treatment and follow up
4. Patients without any known systemic illness
5. Patients not taking any other treatment for last 3 months
6. Patients with moderate acne only that is several to many papules / pustules with few to severe nodules
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant females, married females, desiring to get pregnant or using temporary methods of contraception
2. Patients having family or personal history of hyperlipidemia, diabetes, renal or hepatic disease
3. Patients having drug-induced acne
4. Patients known to be hypersensitive to isotretinoin or unwilling for investigations
5. Patients using other therapies for acne vulgaris
6. Patient age less than 12 years
7. Patients with mild or severe acne vulgaris

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A total of 90 patients will be divided into Group A and B by sequential method. The sample size has been calculated on WHO sample size calculator.
Data will be analyzed using SPSS version 26.0. Descriptive statistics will be calculated as mean ±1 standard deviation for age and duration of lesions. Frequency and percentages will be calculated for qualitative variables like side effects and patients’ satisfaction. Effect modifiers will be controlled through stratification and post-stratification Chi-square test and independent sample t-test will be applied for comparing age and duration of lesions taking p-value less than 0.05 as significant. Chi-square test will be applied to compare efficacy of both drugs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
7/04/2026
Actual
Date of last data collection
Anticipated
5/10/2026
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 26909 0
Pakistan
State/province [1] 26909 0
Sindh

Funding & Sponsors
Funding source category [1] 318528 0
Hospital
Name [1] 318528 0
Pakistan naval ship Shifa hospital , Karachi
Country [1] 318528 0
Pakistan
Primary sponsor type
Hospital
Name
PNS Shifa
Address
Country
Pakistan
Secondary sponsor category [1] 320922 0
None
Name [1] 320922 0
Address [1] 320922 0
Country [1] 320922 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317131 0
Ehtical review committee , PNS Shifa Hospital Karachi.
Ethics committee address [1] 317131 0
Ethics committee country [1] 317131 0
Pakistan
Date submitted for ethics approval [1] 317131 0
18/10/2024
Approval date [1] 317131 0
18/11/2024
Ethics approval number [1] 317131 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140102 0
Dr Muhammad Mudassir
Address 140102 0
Pakistan Naval Ship Shifa hospital, Defense 2, Karachi , Sindh ,post code 07557
Country 140102 0
Pakistan
Phone 140102 0
+923222197483
Fax 140102 0
Email 140102 0
[email protected]
Contact person for public queries
Name 140103 0
Dr Sidra Qayyum
Address 140103 0
Pakistan Naval Ship Shifa hospital, Defense 2, Karachi , Sindh, post code 07557
Country 140103 0
Pakistan
Phone 140103 0
+923323546415
Fax 140103 0
Email 140103 0
[email protected]
Contact person for scientific queries
Name 140104 0
Dr Muhammad Mudassir
Address 140104 0
Pakistan Naval Ship Shifa hospital, Defense 2, Karachi , Sindh, post code 07557
Country 140104 0
Pakistan
Phone 140104 0
+923222197483
Fax 140104 0
Email 140104 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval  [email protected] ethical approval Acne.pdf
Informed consent formAnnexure A [email protected] CONSENT FORM acne. Ddr Sidra.pdf


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.