Comparison of the therapeutic effects of oral fluoxetine and topical clobetasol with topical clobetasol alone in vitiligo patients referred to the Dermatology Clinic of Isfahan University of Medical Sciences.
Design
Patients referred to the clinic, clinical trial with a control group, two groups of 50 patients
Settings and conduct
Vitiligo patients referred to the teaching clinic of Isfahan University of Medical Sciences
Participants/Inclusion and exclusion criteria
1. Age more than 16 years and under 60 years
２. Lack of follicular pigmentation
3. Absence of white hair in the lesion
4. Their lesions should be on the organs and trunk, except for the areas of the ends of the organs, genitalia, periungual and folds
5. Have not received any topical treatment or phototherapy during the last 1 month
6. The extent of involvement is less than 20% of the total body surface.
７. No history of any psychiatric disorder
8. No simultaneous use with monoamine oxidase inhibitor drugs (MAOI)
9. No history of hypersensitivity reaction to fluoxetine or any of the ingredients in the formulation
10. Patients who have not complied with the conditions of taking the drug, such as the prescription for taking the drug, continuing to take the drug, and not taking any other skin drug that affects vitiligo;
11. Female patients who became pregnant during the study.
Intervention groups
The first group is treated with 20 mg fluoxetine tablets and 0.05% clobetasol cream, and the second group is treated only with 0.05% clobetasol cream.
Main outcome variables
The size of the lesion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221020056251N1
Registration date:2023-02-28, 1401/12/09
Registration timing:registered_while_recruiting
Last update:2023-02-28, 1401/12/09
Update count:0
Registration date
2023-02-28, 1401/12/09
Registrant information
Name
mohammad reza pordeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3253 7349
Email address
m.pordeli77@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of adding oral fluoxetine to topical corticosteroid treatment in patients with limited vitiligo form
Public title
Effect of fluoxetinein treatment of vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have not received any topical treatment or phototherapy during the past month.
Lack of follicle pigmentation
Absence of white hair in loss
Their lesions should be on the limbs and trunk, except for the ends of the limbs and genitalia and around the nails and folds
The extent of involvement is less than 20% of the total body surface.
No history of any psychiatric disorder
No simultaneous use with monoamine oxidase inhibitor drugs (MAOI)
No history of hypersensitivity reaction to Fluoxetine or any of the compounds in the formulation
Exclusion criteria:
Age
From 16 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
hezarjerib blvd
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-06-29, 1401/04/08
Ethics committee reference number
IR.MUI.MED.REC.1401.141
Health conditions studied
1
Description of health condition studied
vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
The size of the lesion
Timepoint
3 months after starting treatment
Method of measurement
The surface area of the lesion
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Clobetazol ointment is used daily for 3 hours and Fluoxetine 20 tablets are used daily for 3 months. The training class on how to take the drugs is given once for each patient.
Category
Treatment - Drugs
2
Description
Control group: Clobetazol ointment is used for 3 hours daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sedige Tahereh Hospital
Full name of responsible person
dr nazila pootiyan
Street address
Sedige Tahereh Hospital, Faiz St, Khorram St ,Isfahan,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3335 9090
Email
m.pordeli77@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Isfahan University of Medical Sciences Research Assistant,Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
m.pordeli77@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr nazila poostiyan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology,Al-Zahra Hospital,Isfahan,Iran
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
n.poostiyan@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr nazila poostiyan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology,Al-Zahra Hospital,Isfahan,Iran
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3261 6408
Email
m.pordeli77@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
mohammad reza pordeli
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Department of Dermatology,Al-Zahra Hospital,Isfahan,Iran
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3261 6408
Email
m.pordeli77@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD