Hair Transplantation in Cicatricial Alopecia

Not Applicable

Completed

• Conditions: Cicatricial Alopecia; Hair Transplantation

• Registration Number: NCT04472715
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study Start: 2020-01-05
• Study First Submitted: 2020-07-12
• Study First Submitted QC: 2020-07-12
• Study First Posted: 2020-07-15
• Primary Completion: 2020-12-05
• Study Completion: 2020-12-05
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-23
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
hair regrowth	6 months	transplanted hair develop int new hair growth in bald area

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Alexandria, Egypt