NCT03474718

Brief Summary

The study team will assess the efficacy of platelet-rich plasma therapy, a special blood product which is from the participant's own body, in the treatment of androgenic alopecia (also known as male pattern hair loss) in females.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at P25-P50 for early_phase_1

Timeline
13mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

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 Progress9%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

March 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
8 years until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

March 15, 2018

Last Update Submit

November 20, 2025

Conditions

Androgenic Alopecia

Keywords

scalphair lossplatelet-rich plasma therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Severity of Alopecia Tool (SALT) from baseline

    Change in Severity of Alopecia Tool (SALT) from baseline. SALT scoring - This calculation is based on a scoring system. The scalp is divided into the following 4 areas: Vertex: 40% (0.4) of scalp surface area. Right profile of scalp: 18% (0.18) of scalp surface area. Left profile of scalp: 18% (0.18) of scalp surface area. Posterior aspect of scalp: 24% (0.24) of scalp surface area. Percentage of hair loss in any of these areas is the percentage hair loss multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all the above-mentioned areas. For e.g., if the percentage hair loss in vertex, right profile, left profile and posterior aspect is 20, 30, 40 and 50% respecively; then, SALT score = (20 ´ 0.4) = (30 ´ 0.18) + (40 ´ 0.18) + (50 ´ 0.24) = 8+5.4+7.2+12 = 32.6 Lower score denote better outcomes.

    6 months

Secondary Outcomes (2)

  • Change in Hair Count (number of hairs/0.65cm^2)

    6 months

  • Change in Hair Density (number of hairs/cm^2)

    6 months

Other Outcomes (4)

  • Change in Hair Diameter

    6 months

  • Anagen to Telogen Ratio

    6 months

  • Vellus Hair to Terminal Hair Ratio

    6 months

  • +1 more other outcomes

Study Arms (2)

Group A

EXPERIMENTAL

At the baseline visit subjects will be randomized to either group A or group B. Group A will receive PRP on left side of scalp and placebo (saline solution) on right side of scalp.

Biological: Platelet-rich Plasma Left Side

Group B

EXPERIMENTAL

At the baseline visit subjects will be randomized to either group A or group B. Group B will receive PRP on right side of scalp and placebo (saline solution) on left side of scalp.

Biological: Platelet-rich Plasma Right Side

Interventions

Platelet-rich Plasma Left SideBIOLOGICAL

Group A will receive PRP on left side of scalp and placebo (saline solution) on right side of scalp.

Group A
Platelet-rich Plasma Right SideBIOLOGICAL

Group B will receive PRP on right side of scalp and placebo (saline solution) on left side of scalp.

Group B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female ≥18 years of age at baseline visit.
  • Documentation of androgenic alopecia diagnosis as evidenced by one or more clinical features
  • Not currently on any treatment for alopecia, or has undergone 2-week washout period if recently on medication(s) for alopecia
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study

You may not qualify if:

  • Pregnant or breastfeeding
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  • Have an infection, metastatic disease or certain skin conditions (ie. Psoriasis) which could worsen or spread with injections
  • Diagnosed with a blood or bleeding disorder
  • Diagnosed with anemia
  • Currently on anticoagulant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Baptist Health

Winston-Salem, North Carolina, 27104, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Rita Pichardo, MD

    Wake Forest University School of Medicine, Department of Dermatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

336-716-2903irichard@wakehealth.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Second offsite investigator will assess the patient for clinical improvement and will be unaware of the patient's randomization assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 22, 2018

Study Start

April 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)