Hair Transplantation in Cicatricial Alopecia

EVALUATION OF THE EFFICACY OF FOLLICULAR UNIT EXTRACTION VERSUS FOLLICULAR UNIT EXTRACTION WITH PLATELETS RICH PLASMA IN TREATMENT OF CICATRICAL ALOPECIA

follicular unit extraction as a method of hair transplantation in cicatricial alopecia

Study Overview

• Status: Completed
• Conditions: Cicatricial Alopecia; Hair Transplantation
• Intervention / Treatment: Procedure: follicular unit extarcation and platelet rich plasma

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21521
    • Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: follicular unit extraction; extraction of hair follicle unit from donar area and tranplant it into recepient bald area	Procedure: follicular unit extarcation and platelet rich plasma; hair transplantation procedure
EXPERIMENTAL: foolicular unit extraction and platelet rich plasma; the same procedure mentioned above coupled with session of platelet rich plasma before and after transplantation	Procedure: follicular unit extarcation and platelet rich plasma; hair transplantation procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hair regrowth	transplanted hair develop int new hair growth in bald area	6 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 5, 2020
• Primary Completion (ACTUAL): December 5, 2020
• Study Completion (ACTUAL): December 5, 2020

Study Registration Dates

• First Submitted: July 12, 2020
• First Submitted That Met QC Criteria: July 12, 2020
• First Posted (ACTUAL): July 15, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: hair loss, follicuular unit extraction, platelet rich plasma
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: 00007555

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No