Evaluation and comparison of the efficacy and safety of two regimens of diphencyclopropenone (applying different concentrations to identify the effective concentration vs. traditional method) in the treatment of alopecia areata in patients referred to Razi Hospital, 1398-1399.
comparision of the rate of terminal hair regrowth, time duration to respond to treatment, side effects and patient's satisfaction with diphencyprone (DPCP) with two different regimens, in two separate groups of patients with alopecia areata(AA), based on Severity of Alopecia Tool (SALT) score
Design
clinical trial phase 3, 60 patients, two parallel block randomized groups of 30 patients, followed for 6 months
Settings and conduct
After providing information and obtaining informed consent, 60 patients referring to Razi Hospital DPCP clinic are recruited into the study and randomized between two groups. Regular follow ups will be performed by investigators.
Participants/Inclusion and exclusion criteria
Inclusion ctiteria: patients more than 18 years old with AA ; hair loss grater than 50% ; possibility fo regular visit.exclusion criteria: pregnancy or lactation; systemic immunosuppressive therapy during recent 3 months; hematologic dycrasia ; no response to diphencyprone test ; having androgenitic alopecia ; persistent totalis or universalis areata alopecia from infancy
Intervention groups
Two similar groups with AA ,patients in one group receive DPCP with old regimen ; patients in another group receive DPCP with new redimen ; groups are followed for 6 months in a parallel form
Main outcome variables
Hair regrowth rate; change in SALT score before and after treatment; time to response to treatment; side effects of treatment; patients satisfaction with treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020250N5
Registration date:2019-11-24, 1398/09/03
Registration timing:registered_while_recruiting
Last update:2019-11-24, 1398/09/03
Update count:0
Registration date
2019-11-24, 1398/09/03
Registrant information
Name
Narges Ghandi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5561 8989
Email address
nghandi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the efficacy and safety of two regimens of diphencyclopropenone (applying different concentrations to identify the effective concentration vs. traditional method) in the treatment of alopecia areata in patients referred to Razi Hospital, 1398-1399.
Public title
The comparison of two regimens of diphencyprone in alopecia areata patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with alopecia areata
Possibility of regular visit for the patient
Hair loss more then 50 %
The age of the patient greater than 18 years old
Exclusion criteria:
Pregnancy and lactation
Persistent totalis or universalis areata alopecia from infancy
Prominent androgenetic alopecia
No response to diphencyprone test
Patients with hematologic dysplasia
receiving systemic immunosuppressive therapy during recent 3 months
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
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 Tehran University of Medical Sciences
Street address
Fourth floor, No 23, before Poursina Street, 16 Azar Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-08-24, 1398/06/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.432
Health conditions studied
1
Description of health condition studied
alopecia areata
ICD-10 code
L63
ICD-10 code description
Alopecia areata
Primary outcomes
1
Description
terminal hair regrowth rate with topical diphencyprone with old regimen in comparison to new regimen in patients with alopecia areata, based of SALT score
Timepoint
before intervention and 3 and 6 months after intervention
Method of measurement
Severity of Alopecia Tool Score
Secondary outcomes
1
Description
rate of change in Severity of Alopecia Tool score than the base value, after intervention and at the end of course of treatment
Timepoint
3 and 6 months after treatment
Method of measurement
Severity of Alopecia Tool score
Intervention groups
1
Description
Intervention group1: 30 patients with alopecia areata who are receiving topical diphencyprone with new regimen.
Category
Treatment - Drugs
2
Description
Intervention group 2: 30 patients with alopecia areata who are receiving topical diphencyprone with old regimen
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diphencyprone Clinic- Razi Dermatology Hospital
Full name of responsible person
Doctor Narges Ghandi
Street address
Razi Blind Alley, Vahdate-Islami Square, Vahdate-Islami Street, Tehran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5560 9951
Email
razihospital@sina.tums.ac.ir
Web page address
http://razihos.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Doctor Seyyed Ahmad Rezayi
Street address
sixth floor, Vice Chancellor Of Research And Technology, central organization of Tehran University Of Medical Sciences, at the corner of Qods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?