Hair Transplantation in Cicatricial Alopecia
Primary Purpose
Hair Transplantation, Cicatricial Alopecia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
follicular unit extarcation and platelet rich plasma
Sponsored by
About this trial
This is an interventional treatment trial for Hair Transplantation focused on measuring hair loss, follicuular unit extraction, platelet rich plasma
Eligibility Criteria
Inclusion Criteria:
• Patients with unacceptable visible scarring alopecia.
- Adequate donor area.
- patient free of signs of disease activity evidenced by trichoscopy.
- Patients having inadequate laxity for a strip excision (too tight skin).
- When previous scars of strip surgeries make further strips impossible.
Exclusion Criteria:
• Inadequate donor area.
- Signs of active disease or infection.
- Patient who is not willing for long sessions for several hours or multiple sessions as needed due to the slowness of the process
- Contraindications for surgical procedure as bleeding tendency.
- Contraindications for PRP as (cardiovascular, autoimmune disorders, hematological disorders and neoplasms).
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
follicular unit extraction
foolicular unit extraction and platelet rich plasma
Arm Description
extraction of hair follicle unit from donar area and tranplant it into recepient bald area
the same procedure mentioned above coupled with session of platelet rich plasma before and after transplantation
Outcomes
Primary Outcome Measures
hair regrowth
transplanted hair develop int new hair growth in bald area
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04472715
Brief Title
Hair Transplantation in Cicatricial Alopecia
Official Title
EVALUATION OF THE EFFICACY OF FOLLICULAR UNIT EXTRACTION VERSUS FOLLICULAR UNIT EXTRACTION WITH PLATELETS RICH PLASMA IN TREATMENT OF CICATRICAL ALOPECIA
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 5, 2020 (Actual)
Primary Completion Date
December 5, 2020 (Actual)
Study Completion Date
December 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
follicular unit extraction as a method of hair transplantation in cicatricial alopecia
Detailed Description
The study will include 20 patients with cicatrical alopecia.Patients will be randomly assigned into two groups:Group (A):include ten patients will undergo (FUE) alone.
Group (B): include ten patients will undergo(FUE) and (PRP).3-Surgical technique:
Preoperative Investigations including complete blood count, coagulation profile and hepatitis viral markers.
1-Group(A): will undergo (FUE)
Washing the scalp with antiseptic shampoo before the procedure.
Tumuscentanaesthesia:The donor area is anesthetized with a lidocaine 1% solution diluted with 20 cc saline in addition to adrenaline.
Creation of micropunches(0.7-1 mm) using micromotor.
After removal of the punch,the follicular unit is extracted with Jweler's forceps.
Extracted grafts are then placed on chilled saline gauze for maximum four hours until ready for transplantation.
The recipient area is prepared with rectangular scalpel blades 1mm or hypodermic blades 0.9 mm.
Implantation using fine tipped jweler's forceps.
Finally, receptor and donor areas will be softly cleansed with saline and crepe bandage is applied.
2-Group (B): FUE+PRP
The same procedure will be done but grafts will be placed in Prp solution.
Prp session one week before transplantation then monthly for 3 monthes after (FUE).
Preparation of PRP
10 cc blood will be aspirated in test tube contained a modified solution of anticoagulant,called acid-citrate-dextrose type (ACDA), in which the physiological pH will reached to preserve the platelet integrity.
The first spin of whole blood sample will be at 2500 rpm for 4 minutes
The second spin at 4000 for 20 minutes for obtained plasma.
Platelets are separated as a pellet at the bottom of the tube from platelet-poor plasma (PPP) above. The platelet-rich pellet is resuspended in remaining amount of plasma. The resulting suspension is used as PRP.
Prp is injected in the recipient area. 4-Follow up:
Follow up clinically by digital photographs and trichoscopy 1 week after operation, after 3 months and after 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hair Transplantation, Cicatricial Alopecia
Keywords
hair loss, follicuular unit extraction, platelet rich plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
follicular unit extraction
Arm Type
Experimental
Arm Description
extraction of hair follicle unit from donar area and tranplant it into recepient bald area
Arm Title
foolicular unit extraction and platelet rich plasma
Arm Type
Experimental
Arm Description
the same procedure mentioned above coupled with session of platelet rich plasma before and after transplantation
Intervention Type
Procedure
Intervention Name(s)
follicular unit extarcation and platelet rich plasma
Intervention Description
hair transplantation procedure
Primary Outcome Measure Information:
Title
hair regrowth
Description
transplanted hair develop int new hair growth in bald area
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Patients with unacceptable visible scarring alopecia.
Adequate donor area.
patient free of signs of disease activity evidenced by trichoscopy.
Patients having inadequate laxity for a strip excision (too tight skin).
When previous scars of strip surgeries make further strips impossible.
Exclusion Criteria:
• Inadequate donor area.
Signs of active disease or infection.
Patient who is not willing for long sessions for several hours or multiple sessions as needed due to the slowness of the process
Contraindications for surgical procedure as bleeding tendency.
Contraindications for PRP as (cardiovascular, autoimmune disorders, hematological disorders and neoplasms).
Facility Information:
Facility Name
Faculty of Medicine
City
Alexandria
ZIP/Postal Code
21521
Country
Egypt
12. IPD Sharing Statement
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Hair Transplantation in Cicatricial Alopecia
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