Ignite Creation Date:
2025-12-18 @ 8:23 AM
Ignite Modification Date:
2025-12-23 @ 6:12 PM
Study NCT ID:
NCT04472715
Status:
None
Last Update Posted:
2021-07-29 00:00:00
First Post:
2020-07-12 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hair Transplantation in Cicatricial Alopecia
Sponsor:
None
Organization:
Study Overview
Official Title:
EVALUATION OF THE EFFICACY OF FOLLICULAR UNIT EXTRACTION VERSUS FOLLICULAR UNIT EXTRACTION WITH PLATELETS RICH PLASMA IN TREATMENT OF CICATRICAL ALOPECIA
Status:
None
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: