NCT05409755

Brief Summary

Pattern hair loss, also called androgenetic alopecia (AGA) is considered the most common cause of hair loss in both males and females affecting approximately 85% of males and 50% of females over 50 years of age.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

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

May 20, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

June 25, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

May 20, 2022

Last Update Submit

June 6, 2022

Conditions

Female Pattern Baldness

Outcome Measures

Primary Outcomes (1)

  • Clinical examination by Sinclair scale

    Clinical

    3 months

Study Arms (3)

Fractional microneedling radiofrequency

ACTIVE COMPARATOR

Device

Other: Vivacy

Fractional microneedling radiofrequency followed by minoxidil application

ACTIVE COMPARATOR

Device and drug

Other: Vivacy

Minoxidil

ACTIVE COMPARATOR

Topical drug

Other: Vivacy

Interventions

VivacyOTHER

Vivacy and minoxidil

Fractional microneedling radiofrequencyFractional microneedling radiofrequency followed by minoxidil applicationMinoxidil

Eligibility Criteria

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

You may qualify if:

  • Patients with female pattern hair loss

You may not qualify if:

  • \- Pregnancy and lactation.
  • Bleeding tendency.
  • Cases who received treatment (systemic or topical) in the last 3 months before treatment.
  • Scarring alopecia.
  • Other associated causes of alopecia

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

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
Dr

Study Record Dates

First Submitted

May 20, 2022

First Posted

June 8, 2022

Study Start

June 25, 2022

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

June 8, 2022

Record last verified: 2022-06