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Completed

NCT Number: NCT04472715

Hair Transplantation in Cicatricial Alopecia

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Alexandria, 21521, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

follicular unit extarcation and platelet rich plasma

Procedure

hair transplantation procedure

Primary outcomes

  1. hair regrowth

    Time frame: 6 months

    transplanted hair develop int new hair growth in bald area

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 15, 2020
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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