NCT03388840

Brief Summary

Androgenetic alopecia is the most common type of alopecia in both men and women. About 80 % of Caucasian men and 40-50 % of Caucasian women are affected by androgenetic alopecia. The psychological impact of hair loss due to Androgenetic alopecia can be profound.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

September 18, 2018

Status Verified

February 1, 2018

Enrollment Period

3 years

First QC Date

December 23, 2017

Last Update Submit

September 16, 2018

Conditions

Androgenetic Alopecia

Keywords

platelet rich plasmaadipose derived stem cellsfollicular unit extractionhair transplantation

Outcome Measures

Primary Outcomes (1)

  • hair growth

    Evaluate the effect of adipose derived stem cells intradermally injected in the recipient site during follicular unit extraction for the treatment of androgenetic alopecia on transplanted hair growth in terms of hair density (number of hairs / cm2) in the transplanted region using folliscope.

    12 months

Secondary Outcomes (1)

  • hair shaft diameter

    12 months

Study Arms (2)

Adipose derived stem cells suspention

EXPERIMENTAL

suspension rich in adipose derived stem cells plus platelet rich plasma will be injected at the recipient site during follicular unit extraction for treatment of androgenetic alopecia

Biological: Adipose derived stem cells suspention

Platelet rich plasma

ACTIVE COMPARATOR

platelet rich plasma will be injected at the recipient site during follicular unit extraction for treatment of androgenetic alopecia

Biological: Platelet rich plasma

Interventions

Adipose derived stem cells suspentionBIOLOGICAL

application of adipose derived stem cells to the engrafted hair in hair transplantation surgery

Adipose derived stem cells suspention
Platelet rich plasmaBIOLOGICAL

application of autologous platelet rich plasma to the engrafted hair in hair transplantation surgery

Platelet rich plasma

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • male patients with androgenetic alopecia between 18 years and 60 years

You may not qualify if:

  • Patients with Non-androgenetic causes of hair loss.
  • Female patients with androgenetic alopecia.
  • Patients who received anti-hair loss treatment within the past six months.
  • Patients with history of bleeding disorders or on anticoagulant therapy.
  • Patients with history of chronic liver disease, cancer or connective tissue disorders.
  • Patients with current scalp infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospitals

Asyut, Egypt

RECRUITING

Related Publications (4)

  • Adil A, Godwin M. The effectiveness of treatments for androgenetic alopecia: A systematic review and meta-analysis. J Am Acad Dermatol. 2017 Jul;77(1):136-141.e5. doi: 10.1016/j.jaad.2017.02.054. Epub 2017 Apr 7.

    PMID: 28396101BACKGROUND

  • Navarro RM, Pino A, Martinez-Andres A, Molina C, Martinez AM, Martinez N, Orive G, Anitua E. The effect of plasma rich in growth factors combined with follicular unit extraction surgery for the treatment of hair loss: A pilot study. J Cosmet Dermatol. 2018 Oct;17(5):862-873. doi: 10.1111/jocd.12446. Epub 2017 Oct 26.

    PMID: 29076290BACKGROUND

  • Jimenez-Acosta F, Ponce-Rodriguez I. Follicular Unit Extraction for Hair Transplantation: An Update. Actas Dermosifiliogr. 2017 Jul-Aug;108(6):532-537. doi: 10.1016/j.ad.2017.02.015. Epub 2017 May 5. English, Spanish.

    PMID: 28483047BACKGROUND

  • Qi J, Garza LA. An overview of alopecias. Cold Spring Harb Perspect Med. 2014 Mar 1;4(3):a013615. doi: 10.1101/cshperspect.a013615.

    PMID: 24591533BACKGROUND

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Alaa H Ghazally, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Azza M Abdel-Meguid, PHD

CONTACT

01001801039azzamahfouz@yahoo.com

Doaa A Abou-Taleb, PHD

CONTACT

01001463937dodda_aboutaleb@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 23, 2017

First Posted

January 3, 2018

Study Start

January 15, 2018

Primary Completion

January 1, 2021

Study Completion

March 1, 2021

Last Updated

September 18, 2018

Record last verified: 2018-02

Locations

EG(1)