To assess the efficacy of short-term, pulsed itraconazole regimen compared to placebo in preventing the recurrence of PV following successful initial treatment over a 4 month period.
Design
Community based, parallel group, double blind, randomized controlled trial.
Settings and conduct
All participants will receive initial treatment with itraconazole (Cap Itraconazole 100mg twice daily for 7 DAYS).Following successful initial treatment after 1 week, cured participants will be randomly assigned to either the itraconazole group (Group A) or the placebo group (Group B).Group A will receive Cap Itraconazole 200mg twice a day in a month for 4 consecutive months and Group B will receive placebo. Participants will be assessed with scheduled follow-up visits on monthly intervals for 4 months and then after further 2 months to see sustained response
Study will be conducted in Cmh quetta
Participants/Inclusion and exclusion criteria
Inclusion criteria
● Confirmed diagnosis of PV by clinical examination supported by Wood’s lamp examination
● Age range:13 to 50 years
● Not taken antifungal medication in previous 1 month
● Ability to adhere to treatment and follow-up visits
Exclusion criteria
● Known hypersensitivity to itraconazole or other triazole antifungals
● Liver disease or abnormal liver function tests
● Pregnancy or Nursing mother
● Concurrent use of medications known to interact with itraconazole
● Active fungal infections other than PV
● Immunodeficiency or immunosuppressive therapy
● Any other medical condition deemed a safety risk
Intervention groups
After initial treatment,Group A will receive Cap Itraconazole 200mg twice a day in a month for 4 consecutive months and Group B will receive placebo.
Main outcome variables
Treatment of Pityriasis versicolor based on clinical response and negative wood's lamp examination.
General information
Reason for update
Acronym
pityriasis versicolor PV
IRCT registration information
IRCT registration number:IRCT20210823052264N8
Registration date:2024-09-15, 1403/06/25
Registration timing:registered_while_recruiting
Last update:2024-09-15, 1403/06/25
Update count:0
Registration date
2024-09-15, 1403/06/25
Registrant information
Name
Najia Ahmed
Name of organization / entity
PNS shifa
Country
Pakistan
Phone
+92 81 2864092
Email address
najiaomer@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-21, 1403/05/31
Expected recruitment end date
2025-02-21, 1403/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of itraconazole in the prevention of recurrence of Pityriasis Versicolor
Public title
Efficacy of itraconazole in the prevention of recurrence of Pityriasis Versicolor
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of pityriasis versicolor based on clinical examination supported by Wood's lamp examination
Not taken antifungal medication in previous 1 month
Ability to adhere to treatment and follow-up visits
Exclusion criteria:
Known hypersensitivity to itraconazole or other triazole antifungals
Liver disease or abnormal liver function tests
Pregnancy or nursing mother
Concurrent use of medications known to interact with itraconazole
Active antifungal infections other than pityriasis versicolor
Immunodeficiency or immunosuppressive therapy
Any other medical condition deemed a safety risk by the investigator
Age
From 13 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
All participants will receive initial treatment with itraconazole (Cap Itraconazole 100mg twice daily for 7 DAYS).Following successful initial treatment after 1 week, cured participants will be randomly assigned by lottery method to either the itraconazole group (Group A) or the placebo group (Group B).Group A will receive Cap Itraconazole 200mg twice a day in a month for 4 consecutive months and Group B will receive placebo. Participants will be assessed with scheduled follow-up visits on monthly intervals for 4 months and then after further 2 months to see sustained response. The date of any recurrence and details of the lesions or any adverse events will also be documented during follow-up visits.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blinded study (participant and data analyser are blinded)