Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001007426
Ethics application status
Approved
Date submitted
16/02/2025
Date registered
11/09/2025
Date last updated
11/09/2025
Date data sharing statement initially provided
11/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
comparison of apremilast and methotrexate in moderate to severe psoriasis patients : a randomized control trial
Scientific title
comparison of efficacy and safety of apremilast and methotrexate in moderate to severe psoriasis : a randomized control trial
Secondary ID [1] 313983 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic plaque psoriasis 336706 0
Condition category
Condition code
Skin 333206 333206 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
apremilast ( a phosphodiesterase 4 inhibitor ) orally 30 mg twice daily for 8 weeks. adherence will be checked by observing the no of tablets taken from the pack
Intervention code [1] 330568 0
Treatment: Drugs
Comparator / control treatment
oral tablet of methotrexate weekly 0.3-0.5 mg/kg for 8 weeks
Control group
Active

Outcomes
Primary outcome [1] 340770 0
comparing the efficacy of apremilast vs methotrexate
Timepoint [1] 340770 0
baseline and 8 weeks after intervention commencement
Secondary outcome [1] 445041 0
comparing the safety of apremilast vs methotreaxte in chronic plaque psoriasis
Timepoint [1] 445041 0
at 8 weeks post intervention commencement

Eligibility
Key inclusion criteria
age between 18-65)
both male and female
patinets having moderate to severe psoriasis ( PASI score > 10 )
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnant woman
patients with atopic dermatitis
patients with concomitant autoimmune disease
patients with lichen planus
patients with known hypersensitivity to methotrexate or apremilast

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
10/11/2025
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment outside Australia
Country [1] 26898 0
Pakistan
State/province [1] 26898 0
KPK

Funding & Sponsors
Funding source category [1] 318485 0
Hospital
Name [1] 318485 0
khyber teaching hospital peshawar
Country [1] 318485 0
Pakistan
Primary sponsor type
Individual
Name
dr imdad ullah khan - khyber teaching hospital peshawar, dermatology department
Address
Country
Pakistan
Secondary sponsor category [1] 320878 0
Hospital
Name [1] 320878 0
khyber teaching hospital peshawar
Address [1] 320878 0
Country [1] 320878 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317094 0
khyber medical college peshawar IREB ( institutional research and ethical review board )
Ethics committee address [1] 317094 0
Ethics committee country [1] 317094 0
Pakistan
Date submitted for ethics approval [1] 317094 0
01/01/2025
Approval date [1] 317094 0
23/01/2025
Ethics approval number [1] 317094 0

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

Contacts
Principal investigator
Name 139978 0
Dr IMDAD ULLAH KHAN
Address 139978 0
IMDAD ULLAH KHAN,DERMATOLOGY DEPARTMENT,UNIVERSITY TOWN, KHYBER TEACHING HOSPITAL , PESHAWAR, KPK, PAKISTAN, POSTAL CODE 25000
Country 139978 0
Pakistan
Phone 139978 0
+923438979808
Fax 139978 0
Email 139978 0
[email protected]
Contact person for public queries
Name 139979 0
IMDAD ULLAH KHAN
Address 139979 0
IMDAD ULLAH KHAN,DERMATOLOGY DEPARTMENT,UNIVERSITY TOWN, KHYBER TEACHING HOSPITAL , PESHAWAR, KPK, PAKISTAN, POSTAL CODE 25000
Country 139979 0
Pakistan
Phone 139979 0
+923438979808
Fax 139979 0
Email 139979 0
[email protected]
Contact person for scientific queries
Name 139980 0
IMDAD ULLAH KHAN
Address 139980 0
IMDAD ULLAH KHAN,DERMATOLOGY DEPARTMENT,UNIVERSITY TOWN, KHYBER TEACHING HOSPITAL , PESHAWAR, KPK, PAKISTAN, POSTAL CODE 25000
Country 139980 0
Pakistan
Phone 139980 0
+923438979808
Fax 139980 0
Email 139980 0
[email protected]

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


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.