Investigating the efficacy and safety of platelet rich plasma and topical clobetasol in treating hair loss of patients with lichen planopilaris in comparison to the patients who only use topical clobetasol
Using a new treatment method with better results in patients with lichen plano pilaris
Design
Tow arm parallel group randomised trial without blinding on 22 patients.
Settings and conduct
We will take 20cc blood of peripheral vein of patients with lichen plano pilaris registered in dermatology clinic of Rasoul Akram Hospital. then after centrifuging 1500rpm in 5 minutes , the paltelet rich part will be seperated and injected to the site with syringe gage 30.
Participants/Inclusion and exclusion criteria
The patients should only have lichen planopilaris and no other form of generalized or erosive lichen planus. also, only patients who could not take benefit of systemic treatments will enter the study.
Intervention groups
In the patients of case group, 11 patients receive both topical clobetasol and PRP injection. The patients of control group will receive only topical clobetasol.
Main outcome variables
Reduction of hair loss; scalp pruritus; scalp erythema and perifollicular scaling
General information
Reason for update
Acronym
Lichen Planopilaris (LPP)
IRCT registration information
IRCT registration number:IRCT20221018056229N1
Registration date:2023-01-28, 1401/11/08
Registration timing:retrospective
Last update:2023-01-28, 1401/11/08
Update count:0
Registration date
2023-01-28, 1401/11/08
Registrant information
Name
Zahra Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 8412
Email address
zahra_lotfi90@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-05, 1401/09/14
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the efficacy and safety of platelet rich plasma and topical clobetasol in treating hair loss of patients with lichen planopilaris in comparison to the patients who only use topical clobetasol
Public title
Investigating the efficacy and safety of platelet rich plasma in treating hair loss of patients with lichen planopilaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18 years old and more
Definite and resistant hair loss due to LPP
The patient gives informed consent
The patient can participate in regular follow up meetings
The patient does not have serious internal disease
The patient does not have cutaneous disease in the site of treatment
Exclusion criteria:
History of any remedies taken in last month
Positive history of liver, kidney, pulmonary, cardiac, and intestinal disease and malignancies
Taking any medications for any disease which makes drug reactions possible
Accompanying of LPP with generalized lichen planus or erosive mucosal form
Other forms of noncicatricial or other forms of cicatricial alopecia except LPP
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
22
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
Iran University of Medical Sciences Ethics' Committee
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-08-23, 1401/06/01
Ethics committee reference number
IR.IUMS.FMD.REC.1401.310
Health conditions studied
1
Description of health condition studied
Scalp hair lichen planopilaris
ICD-10 code
L43.8
ICD-10 code description
Other lichen planus
Primary outcomes
1
Description
The amount of scalp erythema based on LPPI
Timepoint
Investigating of scalp hair situation with using dermatoscope, at the first visit, at 1 month and 2 months and then 6 months after the first visit
Method of measurement
Dermatoscopy with dermatoscope
2
Description
The amount of scalp scaling based on LPPI
Timepoint
Investigating of scalp hair situation with using dermatoscope, at the first visit, at 1 month and 2 months and then 6 months after the first visit
Method of measurement
Dermatoscopy with dermatoscope
3
Description
The amount of scalp pruritus based on LPPI
Timepoint
Investigating of scalp hair situation with using dermatoscope, at the first visit, at 1 month and 2 months and then 6 months after the first visit
Method of measurement
Dermatoscopy with dermatoscope
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the patients will receive Behvazan topical clobetasol 0.05% lotion 20 drops every night, and they will also receive 3 courses of PRP in 1-month intervals. Each PRP treatment session is as described subsequently: After aspirating 20cc of the patient's venous blood, the blood is centrifuged in 4 citrated sample tubes with 1500rpm in the Iranian Universal centrifuge device. Then the middle part of the plasma (rich with platelets) is extracted and injected intradermally into the patient's scalp with a 30-gauge needle.
Category
Treatment - Drugs
2
Description
Control group: the patients will receive Behvazan topical clobetasol 0.05% lotion 20 drops every night