Clinical comparison between oral low dose of Naltrexone and standard medication in patients with Frontal Fibrosing Alopecia referred to educational clinics of Isfahan University of Medical Sciences.
Design
The clinical trial includes two treatment groups with parallel groups, single blind, randomized, phase 2-3, on 30 patients, SPSS will use for randomization.
Settings and conduct
This study will conduct as a randomized clinical trial from the spring of 1401 to the end of 1403 in the dermatology clinic of Isfahan Al-Zahra Hospital and other clinics and teaching hospitals affiliated to Isfahan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- New patients with FFA who have not received any medicine so far
2-Patients who have previously been treated with systemic drugs and have not received systemic drugs in the last one month. Based on clinical and trichoscopic criteria, their disease is active.
3-Patients who are treated with topical medicine and whose disease is still active based on clinical and trichoscopic criteria.
Criteria for not entering the study:
1-Pregnancy or breastfeeding
2-History of hypersensitivity to Naltrexone drug
3- Addiction to opium or abuse of opioids
4- Personal or family history of breast cancer
Intervention groups
In this study, patients are divided into two groups. Group1 includes people who will treat with standard and common drugs (finasteride , minoxidil , Pimecrolimus, etc.). Group 2 includes people who will treat with Naltrexone.
Main outcome variables
Prefollicular scale; Interfollicular scale; Erythema; Decline in frontal and temple hair line
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230326057776N1
Registration date:2023-04-01, 1402/01/12
Registration timing:prospective
Last update:2023-04-01, 1402/01/12
Update count:0
Registration date
2023-04-01, 1402/01/12
Registrant information
Name
Fatemeh Azadmanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3626 1844
Email address
fatemehazadmanesh95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical comparison between oral low dose of Naltrexon and standard medication in patients with Frontal Fibrosing Alopecia
Public title
Effects of Naltrexon in patients with Frontal Fibrosing Alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
New patients without any other medications
Active status of illness after leaving a systemic medication (at least a month)
Active status of illness while the participants are using a topical medication
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple;
Randomization unit: Personal;
Randomization tools: SPSS software;
All the participants receive a number from 1 to 30. Then they share between two groups of Naltrexon/standard medication by a simple randomization method with SPSS
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are randomly assigned to one of the two groups of naltrexone treatment and standard treatment, but they do not know which group they are in. The design of study are described for patients.
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
Isfahan University of Medical Sciences, Hezar-Jarib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-12-29, 1401/10/08
Ethics committee reference number
IR.MUI.MED.REC.1401.349
Health conditions studied
1
Description of health condition studied
Frontal Fibrosing Alopecia
ICD-10 code
L66.9
ICD-10 code description
Cicatricial alopecia, unspecified
Primary outcomes
1
Description
Pre-follicular scale
Timepoint
Examinations is done at the beginning of the study and then 2, 4 and 6 months later.
Method of measurement
Using Dermoscope
2
Description
Erythema
Timepoint
Examinations is done at the beginning of the study and then 2, 4 and 6 months later.
Method of measurement
Observiation
3
Description
Interfollicular scale
Timepoint
Examinations is done at the beginning of the study and then 2, 4 and 6 months later
Method of measurement
Using a dermoscope
4
Description
Decline in frontal and temple hair line
Timepoint
Examinations is done at the beginning of the study and then 2, 4 and 6 months later
Method of measurement
Using a ruler
Secondary outcomes
1
Description
ceasing the progression of disease
Timepoint
Examination is done at the beginning of the study and then 2, 4 and 6 months later.
Method of measurement
Frontal Fibrosing Alopecia Severity Index (FFASI)
Intervention groups
1
Description
Intervention group: Naltrexon
Category
Treatment - Drugs
2
Description
Intervention group: Standard medication
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Fatemeh Azadmanesh
Street address
Shohadaye-Sofe Ave, Al-Zahra Hospital, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
fatemehazadmanesh95@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Iraji
Street address
Shohadaye-Sofe Ave, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
iraji@med.mui.ac.ir
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
25
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
Fatemeh Azadmanesh
Position
Resident of Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shohadaye-Sofe Ave, Al-Zahra Hospital, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
009831202020
Email
fatemehazadmanesh95@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mina Saber
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shohadaye-Sofe Ave, Al-Zahra Hospital, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
mina.saber33@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mina Saber
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shohadaye-Sofe Ave, Al-Zahra Hospital, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
mina.saber33@yahoo.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
There is a possibility that patients' privacy will be lost.