aim is to select the optimal treatment for pitryasis versicolor.
Design
Pragmatic, community based, parallel group, not blind, randomised controlled trial.
Settings and conduct
This study will be conducted on patients presenting in dermatology OPD fullfilling the incluaion criteria.
Study is Not blinded
Participants/Inclusion and exclusion criteria
60 participants, 30 in each group.
All patients who will have clinically pitryasis versicolor leisions as pe operational definition within age range of 18-60years and willing to provide informed consent are included.
Patients who are previously treated and are allergic to topical medication are excluded.
Patients develop side effects during study also excluded.
Intervention groups
Group A of 30 patients will recieve topical bifonazole
Group B of 30 patients will recieve topical clotrimazole
Main outcome variables
Efficacy with clinical and mycological cure: yes/no
Side effects if any: yes/no
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241028063523N1
Registration date:2024-11-06, 1403/08/16
Registration timing:registered_while_recruiting
Last update:2024-11-06, 1403/08/16
Update count:0
Registration date
2024-11-06, 1403/08/16
Registrant information
Name
Atiya Rahman
Name of organization / entity
Bahria University of Health Sciences Campus Karachi Pakistan
Country
Pakistan
Phone
+92 21 35319491
Email address
atiyarahman.bumdc@bahria.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-01, 1403/08/11
Expected recruitment end date
2025-04-30, 1404/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of bifonazole and clotrimazole in the treatment of pitryasis versicolor
Public title
Comparative efficacy of bifonazole and clotrimazole in the treatment of pitryasis versicolor
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who will have clinically pitryasis versicolor as per operational definition
Patients within range of 18-60 years of age
Willing to provide informed consent
Exclusion criteria:
Patients with local inflammatory of infectious disease at the site to be treated or who will be allergic to topical medication
Previously treated patients
Patients delevelop side effects during study
Age
From 18 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
All patients presenting in OPD of dermatology Department of PNS Shifa hospital fulfilling inclusion criteria will be included.
Patients will be divided into groups using lottery method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of PNS Shifa
Street address
PNS Shifa Hospital.Sailor street DHA phase ll, near Kala pul.
City
Karachi
Postal code
75500
Approval date
2024-04-05, 1403/01/17
Ethics committee reference number
ERC/2023/DERM/84
Health conditions studied
1
Description of health condition studied
Pitryasis versicolor is a chronic cutaneous fungal infection caused by proliferation of lipophilic yeast (malassezia species) in stratum corneum.
ICD-10 code
B36.0
ICD-10 code description
Pityriasis versicolor
Primary outcomes
1
Description
The primary outcome of the study will focus on mycological cure ( negative microscopy of fungal hyphae by potassium hydroxide mount)
Timepoint
Patient will be assessed before intervention, at 2 weeks and 4 weeks after intervention
Method of measurement
Method used to assess mycological cure will be skin scrapping mount with potassium hydroxide( negative for fungal hyphae)
2
Description
The primary outcome of the study will focus on alleviation of physical symptoms such as leision clearence ,erythema, pruritis, desqamation and absence of yellow floresence on wood's lamp examination.
Timepoint
Patient will be assessed Before intervention,at 2 weeks and 4 weeks after intervention
Method of measurement
Method used to assess clinical cure will be wood's lamp examination(absence of clinical signs)
Secondary outcomes
1
Description
tolerability of drugs by monitoring side effects
Timepoint
At 2 weeks and at 4 weeks
Method of measurement
i will measure clinical cure by woods lamp examination(absence of signs) and mycological cure by skin scrapping (negative for fungal hyphae) and side effects (if any)
Intervention groups
1
Description
Clinically and mycologically confirmed cases of Pitryasis versicolor shall be divided into 2 groups. Group 1 and Group 2. INTERVENTION GROUP 1 will have 30 patients and they will be recieving bifonazole 1% w/w cream under trade name of BIFOMYK( manufactured by Bioglan pharma. Pakistan ) topical application twice daily for a period of 4 weeks. Response to treatment,disease recurrence and any local or systemic side effects will be checked after 2 and 4 weeks from starting the treatment and they will be followed up for 1 month after stopping the treatment,clinically and with lab investigations by absence of yellow floresence on wood's lamp examination and absence of fungal hyphae on microscopy after scrapping mount with potassium hydroxide. Patients will be adviced at the time of prescription to apply thin layer of cream that would be absorbed over leisions. Otherwise there is no educational session in this study. The response of treatment shall be entered in pre designed performa to assess the efficacy of 2 therapeutic agents bifonazole and clotrimazole clinically by by absence of yellow floresence on wood's lamp examination and absence of fungal hyphae on microscopy after scrapping mount with potassium hydroxide. The data will be entered and analyzed by using SPSS statistical package version 21 software .
Category
Treatment - Drugs
2
Description
INTERVENTION GROUP 2 will have 30 patients and they will be recieving clotrimazole 1% w/w cream under trade name of CANESTEN ( manufactured by Bayer pakistan pvt. Ltd ), topical application twice daily for a period of 4 weeks. Response to treatment, disease recurrence and any local or systemuc side effects will be checked after 2 weeks, 4 weeks from starting the treatment and they will be followed up for 1 month after stopping the treatment, clinically and with lab investigation by absence of yellow floresence on woods lamp examination and absence of fungal hyphae on microscopy after scrapping mount with potassium hydroxide. Patients will be adviced at the time of prescription to apply small amout of cream that would be absorbed over leisions. Otherwise there is no educational session in this study. The response of treatment shall be entered in pre designed performa to assess the efficacy of 2 therapeutic agents bifonazole and clotrimazole clinically by by absence of yellow floresence on wood's lamp examination and absence of fungal hyphae on microscopy after scrapping mount with potassium hydroxide. The data will be entered and analyzed by using SPSS statistical package version 21 software
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
PNS Shifa Hospital
Full name of responsible person
Dr Sana Saleem
Street address
PNS shifa Hospital
City
Karachi
Postal code
75500
Phone
+92 21 48506540
Email
sanasaleem2694@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Armed forces Hospital PNS Shifa Karachi,Pakistan
Full name of responsible person
Dr Sana Saleem
Street address
DHA phase ll, PNS Shifa hospital, near Kala pul.
City
Karachi
Postal code
75500
Phone
+92 21 48506540
Email
sanasaleem20694@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Armed forces Hospital PNS Shifa Karachi,Pakistan
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Armed forces Hospital, PNS Shifa
Full name of responsible person
Dr Atiya Rahman
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sailor street, DHA phase ll, PNS Shifa
City
Karachi
Province
Sindh
Postal code
75500
Phone
+92 21 48506540
Email
sanasaleem20694@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Armed forces Hospital, PNS shifa
Full name of responsible person
Dr Atiya Rahman
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sailor street DHA phase ll near Kala pul
City
Karachi
Province
Sindh
Postal code
75500
Phone
+92 21 48506540
Email
sanasaleem20694@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Armed forces hospital, PNS shifa
Full name of responsible person
Dr Sana Saleem
Position
Post graduate resident
Latest degree
Bachelor
Other areas of specialty/work
Dermatology
Street address
sailors street DHA phase ll, near kala pul
City
Karachi
Province
Sindh
Postal code
75500
Phone
+92 21 48506540
Email
sanasaleem20694@gmail.com
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
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
APPENDIX 1: PERFORMA
Name, age, gender, address, contact number, weight, height, duration of disease, site group (A,B)
INFORMED CONSENT.
When the data will become available and for how long
After 6 months RCT, for 4 years.
To whom data/document is available
primary investigator
Under which criteria data/document could be used
All patients in dermatology opd according to operational definition of pitryasis versicolor fullfilling the inclusion criteria.
From where data/document is obtainable
administration of PNS SHIFA HOSPITAL
What processes are involved for a request to access data/document