NCT06326359

Brief Summary

Evaluation of Safety and efficacy of autologous stromal vascular fraction derived from denovo versus platelet rich plasma enhanced donner site in treatment of male androgenic alopecia

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Mar 2024

Typical duration for not_applicable

Status
not yet recruiting

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

Study Progress84%
Mar 2024Oct 2026

Study Start

First participant enrolled

March 1, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

March 9, 2024

Last Update Submit

March 16, 2024

Conditions

Keywords

autologous stromal vascular fractionplatelet rich plasmamale androgenic alopecia

Outcome Measures

Primary Outcomes (2)

  • hair density

    Trichoscopy

    at baseline and at 6 month after treatment

  • hair shaft thickness

    TrichoScan

    at baseline and at 6 month after treatment

Study Arms (2)

autologous stromal vascular fraction derived from denovo

ACTIVE COMPARATOR

autologous stromal vascular fraction derived from denovo in male androgenic alopecia

Procedure: autologous stromal vascular fraction

autologous stromal vascular fraction after platelet rich plasma enhanced donner site

ACTIVE COMPARATOR

autologous stromal vascular fraction after platelet rich plasma enhanced donner site in male androgenic alopecia

Procedure: autologous stromal vascular fraction

Interventions

autologous stromal vascular fraction injection as 2 sessions with 1 month interval at arm 1 arm 2: will receive 2 sessions of PRP with 3 weeks interval followed by stromal vascular fraction injection as 2 sessions with 1 month interval

autologous stromal vascular fraction after platelet rich plasma enhanced donner siteautologous stromal vascular fraction derived from denovo

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male patients with androgenic alopecia

You may not qualify if:

  • Patients with other hair loss disorders as telogen effluvium, anagen effluvium, alopecia areata, cicatricial alopecia and trichotillomania.
  • Any other cutaneous disease as patients suffering from dermatological condition or a significant scarring in the treatment area.
  • Any systemic disease as autoimmune disorders , cardiac hepatic and renal patients.
  • patients who received minoxidil or any other oral, topical medications (including herbal medications) or injection procedures for the treatment of hair loss within 6 months prior to the study, or finasteride or dutasteride within 12 months of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

dina A mahmoud, assistant lecturer

CONTACT

reham E Elsharkawy, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

March 9, 2024

First Posted

March 22, 2024

Study Start

March 1, 2024

Primary Completion

October 1, 2024

Study Completion (Estimated)

October 1, 2026

Last Updated

March 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share