Hair Transplantation in Cicatricial Alopecia

Cicatricial Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04472715
• Other study ID #: 00007555
• Status: Completed
• Phase: N/A
• Start date: January 5, 2020
• Est. completion date: December 5, 2020

Study information

• Verified date: July 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 5, 2020
• Est. primary completion date: December 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Cicatricial Alopecia
• Hair Transplantation

Intervention

Procedure:
• follicular unit extarcation and platelet rich plasma
hair transplantation procedure

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hair regrowth	transplanted hair develop int new hair growth in bald area	6 months