NCT04472715

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2020

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

11 months

First QC Date

July 12, 2020

Last Update Submit

July 23, 2021

Conditions

Hair TransplantationCicatricial Alopecia

Keywords

hair loss, follicuular unit extraction, platelet rich plasma

Outcome Measures

Primary Outcomes (1)

  • hair regrowth

    transplanted hair develop int new hair growth in bald area

    6 months

Study Arms (2)

follicular unit extraction

EXPERIMENTAL

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

Procedure: follicular unit extarcation and platelet rich plasma

foolicular unit extraction and platelet rich plasma

EXPERIMENTAL

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

Procedure: follicular unit extarcation and platelet rich plasma

Interventions

follicular unit extarcation and platelet rich plasmaPROCEDURE

hair transplantation procedure

follicular unit extractionfoolicular unit extraction and platelet rich plasma

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Alexandria, 21521, Egypt

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of dermatology

Study Record Dates

First Submitted

July 12, 2020

First Posted

July 15, 2020

Study Start

January 5, 2020

Primary Completion

December 5, 2020

Study Completion

December 5, 2020

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations

EG(1)