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Not yet recruitingNCT03474718Updated Nov 5, 2026

Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia

An Early Phase 1 interventional study of Platelet-rich Plasma Left Side and Platelet-rich Plasma Right Side in Androgenic Alopecia, sponsored by Wake Forest University Health Sciences. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Wake Forest University Health Sciences · Early Phase 1, Interventional, and Treatment

Updated Nov 5, 2026Start date movedGo to Updates ↓
Phase
Early Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

Androgenic alopecia, or male-pattern hair loss affects both men and women. This hair loss pattern is typically characterized by thinning at the crown of scalp and/or M-shaped hair line in males or diffuse thinning throughout in females. Platelet-rich plasma (PRP) therapy has recently been studied as a hair rejuvenation therapy in patients with non-inflammatory alopecia. Though the mechanism of action is not well understood, PRP is thought to promote angiogenesis and enhance blood flow around hair follicles via platelet-derived growth factor (PDGF), transforming growth factor (TGF), and vascular endothelial growth factor (VEGF). The primary objective of the study is to determine whether PRP, administered once monthly for 3 months improves clinical outcomes and quality of life in females with androgenic alopecia. This is a randomized, placebo-controlled, double-blind, half-head, single center clinical study where sixteen subjects with androgenic alopecia will be recruited. Dermatology Life Quality Index will be assessed at several time points. Disease severity will be measured using the Severity of Alopecia Tool (SALT), Alopecia Density and Extent Score (ALODEX); Trichoscan images will be captured to document participants' clinical progress. Adverse events will be recorded at each visit, treatment will be discontinued if any subject experience a serious adverse event. Treatment visits will take place at baseline, 4 weeks (1 month), 8 weeks (2 months), and 12 weeks (3 month). A follow-up, non-treatment visit will take place at 24 weeks (6 months). The study team hypothesizes that PRP will improve DLQI, SALT, ALODEX, hair count (number of hairs/0.65 cm2), hair density (number of hairs/cm2), hair diameter, anagen to telogen ratio, and vellus hair to terminal hair ratio in female subjects with androgenic alopecia.

02

Conditions studied

  • Androgenic Alopecia

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Keywords

  • scalp
  • hair loss
  • platelet-rich plasma therapy
03

In context

Alopecia

511 studies on the registry are indexed under Alopecia; 128 are open to participants now.

This study's planned enrollment of 16 is below the median of 50 across 430 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.

Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 if recently on medication(s) for alopecia
  • Written obtained from subject and ability for subject to comply with the requirements of the study

Exclusion criteria

Exclusion Criteria:

  • 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, 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Group A

    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

  • Experimental
    Group B

    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

  • BiologicalPlatelet-rich Plasma Left Side

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

  • BiologicalPlatelet-rich Plasma Right Side

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

06

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

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

    Change in Hair Count (number of hairs/0.65cm\^2), as assessed via Trichoscan

    Time frame: 6 months

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

    Change in Hair Density (number of hairs/cm\^2), as assessed via Trichoscan

    Time frame: 6 months

Other outcomes

  1. Change in Hair Diameter

    Change in Hair Diameter, as assessed via Trichoscan

    Time frame: 6 months

  2. Anagen to Telogen Ratio

    Anagen to Telogen Ratio, as assessed via Trichoscan

    Time frame: 6 months

  3. Vellus Hair to Terminal Hair Ratio

    Vellus Hair to Terminal Hair Ratio, as assessed via Trichoscan

    Time frame: 6 months

  4. Change in Dermatology Life Quality Index (DLQI)

    Change in Dermatology Life Quality Index (DLQI) 10 question are asked pertaining to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The scoring of each answer is as follows: Very much scored 3 A lot scored 2 A little scored 1 Not at all scored 0 Not relevant scored 0 Question unanswered scored 0 Question 7: "prevented work or studying" scored 3 The DLQI is calculated by adding the score of each question. The maximum score is 30 and the minimum is 0. The higher the score, the more quality of life is impaired. Meaning of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life

    Time frame: 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Jul 2027, 7 months later.

Of 33 phase 1 interventional studies under Alopecia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 57. This study's planned 7 months is below that.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Dec 2026, on Nov 5, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2018
First posted
Mar 22, 2018
StartEst.
Dec 2026was Oct 2026
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2027
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Oct 2026→Dec 2026
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Start date Oct 2026→Dec 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03474718
Responsible party
Sponsor
First posted
Mar 22, 2018
Start date
Dec 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Research Coordinator
Contact
irichard@wakehealth.edu
336-716-2903
Rita Pichardo, MD
principal investigator · Wake Forest University School of Medicine, Department of Dermatology

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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