Hair Transplantation in Cicatricial Alopecia

NCT ID: NCT04472715

Last Updated: 2021-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-05
• Study Completion Date: 2020-12-05

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.

Conditions

Hair Transplantation; Cicatricial Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

follicular unit extraction

extraction of hair follicle unit from donar area and tranplant it into recepient bald area

Group Type: EXPERIMENTAL

follicular unit extarcation and platelet rich plasma

Intervention Type: PROCEDURE

hair transplantation procedure

foolicular unit extraction and platelet rich plasma

the same procedure mentioned above coupled with session of platelet rich plasma before and after transplantation

Group Type: EXPERIMENTAL

follicular unit extarcation and platelet rich plasma

Intervention Type: PROCEDURE

hair transplantation procedure

Interventions

follicular unit extarcation and platelet rich plasma

hair transplantation procedure

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

marwa eldeeb

Lecturer of dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

00007555

Identifier Type: -

Identifier Source: org_study_id