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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Platelet-rich Plasma Left Side

    Biological/Vaccine

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

  • Platelet-rich Plasma Right Side

    Biological/Vaccine

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

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention

Trial outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: