Comparative evaluation of the response rate based on tricoscopic criteria in patients with severe alopecia areata treated with diphencyprone with or without intralesional platelet rich plasma
Comparative evaluation of response to treatment based on trichoscopic criteria in patients with severe alopecia areata treated with diphen cypron with and without intra-lesional platelet rich plasma injection
Design
A clinical trial with 20 sample size of patient with severe alopecia areata. Every patient is their own control
single groups, double blinded and randomized (Random block)
Settings and conduct
Patients are selected from referrals to Diphen Ciprone Clinic at Department of Dermatology, Razi Hospital. The test was performed with 2% diphen cypron solution and continues based on routine protocols for whole scalp. after reaching the appropriate concentration, PRP injection sessions begin on one side of the scalp. Randomized block method was used to randomize treatments to the head sides (left and right). Inject 3 sessions at one month interval. The study is double-blinded (Participant,Outcome assessor and data analyser are blinded and Care provider (Investigator) are aware)
Participants/Inclusion and exclusion criteria
Inclusion
1.Patients with severe alopecia areata (> 50% scalp and less than 100%)
2. Positive response to test with 2% Diphen Ciprone solution
exclusion
1. alopecia totalis/universalis
2. Receiving systemic treatment in the past 6 months
3. Children under 18 years
4. Pregnant and lactating women
5. Immunosuppressants
6. People with platelet dysfunction
7. Taking intralesional steroid over the last month
8. Fever, systemic and topical infection at the injection site
Intervention groups
All patients receive the intervention, which is the injection of platelet-rich plasma(PRP). Every person is their own control. the whole scalp takes Diphen Ciprone and only one side (right or left) takes PRP.
Main outcome variables
Patients with severe alopecia areata respond more significantly to treatment with PRP and diphenyl cyprone together in comparison with diphenyl cyprone alone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200130046311N1
Registration date:2021-04-13, 1400/01/24
Registration timing:retrospective
Last update:2021-04-13, 1400/01/24
Update count:0
Registration date
2021-04-13, 1400/01/24
Registrant information
Name
azadeh rezayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7778 7105
Email address
azadehrezayat@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-29, 1398/12/10
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the response rate based on tricoscopic criteria in patients with severe alopecia areata treated with diphencyprone with or without intralesional platelet rich plasma
Public title
Comparison of the effect of DiphenCiprone alone and DiphenCiprone with intralesional injection of platelet-rich plasma in alopecia areata
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A patient with alopecia areata whose definitive diagnosis was made on clinical or histological basis and their involvement was severe (> 50% scalp area and less than 100%).
Positive response to test with 2% Diphen Ciprone solution
Exclusion criteria:
Patients with alopecia totalis or universalis
Receive any systemic treatment during the last 6 months
Children under 18 years
Pregnant and lactating women
Immunosuppressed patient
patient with platelet dysfunction
patient with a history of injecting steroids on the site over the past month
Fever, systemic infection and local infection at the injection site
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized block method was used to randomize treatments to the two different head area(left and right). Blocks in the size of 2 and 4 were used to generate random blocks
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients participating in the study were unaware of which side of the scalp received PRP and which side the placebo.
The care provider , who is also the investigator, is aware of this.
People who analyze photographic images to determine SALT and dermoscopic images are unaware.
The statistical consultant for data analysis is also unaware.
Placebo
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
Building No. 1 - Enghelab Ave. - Qods Street - Porsina Street - North Door of the University Tehran, Iran
City
tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-09-20, 1398/06/29
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.505
Health conditions studied
1
Description of health condition studied
Alopecia areata
ICD-10 code
L63.8
ICD-10 code description
Other alopecia areata
Primary outcomes
1
Description
severity alopecia tool score (SALT score)
Timepoint
Trichoscopic evaluation at baseline, 3 months later, 6 months later
Method of measurement
Trichoscope
Secondary outcomes
1
Description
SALT score evaluation
Timepoint
Evaluation at baseline, 3 months later, 6 months later
Method of measurement
visual evaluation
Intervention groups
1
Description
Intervention group: taking Diphen Ciprone and platelet-rich plasma together. All patients participating in the study received diphen cyprone and PRP simultaneously on one side of their head (right or left randomized). Patients who respond positively to 2% diphen cyprone solution enter the next stages of treatment, starting with 0.0001% solution. After this, the patient goes to the Diphen Cypron clinic every one to two weeks and based on the patient's symptoms and the discretion of the physician, the treatment is continued with a gradual increase in the drug concentration. PRP injection is started as soon as the appropriate concentration of diphen cyprone is reached for each patient (causing mild, tolerable itching, scaling, and erythema). PRP injection is done with a one-month interval of 3 sessions.
Category
Treatment - Other
2
Description
Control group: Each person is his own control. This means that the opposite side of the head (right or left) is treated with topically Diphen cyprone and placebo injection. Its frequency and dose are completely in accordance with the intervention group