Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Primary Purpose
Androgenic Alopecia
Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Platelet-rich Plasma Left Side
Platelet-rich Plasma Right Side
Sponsored by
About this trial
This is an interventional treatment trial for Androgenic Alopecia focused on measuring scalp, hair loss, platelet-rich plasma therapy
Eligibility Criteria
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 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
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, 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
Sites / Locations
- Wake Forest University Baptist Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Hair Count (number of hairs/0.65cm^2)
Change in Hair Count (number of hairs/0.65cm^2), as assessed via Trichoscan
Change in Hair Density (number of hairs/cm^2)
Change in Hair Density (number of hairs/cm^2), as assessed via Trichoscan
Full Information
NCT ID
NCT03474718
First Posted
March 15, 2018
Last Updated
September 25, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03474718
Brief Title
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Official Title
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenic Alopecia
Keywords
scalp, hair loss, platelet-rich plasma therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Second offsite investigator will assess the patient for clinical improvement and will be unaware of the patient's randomization assignment.
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Platelet-rich Plasma Left Side
Intervention Description
Group A will receive PRP on left side of scalp and placebo (saline solution) on right side of scalp.
Intervention Type
Biological
Intervention Name(s)
Platelet-rich Plasma Right Side
Intervention Description
Group B will receive PRP on right side of scalp and placebo (saline solution) on left side of scalp.
Primary Outcome Measure Information:
Title
Change in Severity of Alopecia Tool (SALT) from baseline
Description
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 Outcome Measure Information:
Title
Change in Hair Count (number of hairs/0.65cm^2)
Description
Change in Hair Count (number of hairs/0.65cm^2), as assessed via Trichoscan
Time Frame
6 months
Title
Change in Hair Density (number of hairs/cm^2)
Description
Change in Hair Density (number of hairs/cm^2), as assessed via Trichoscan
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Change in Hair Diameter
Description
Change in Hair Diameter, as assessed via Trichoscan
Time Frame
6 months
Title
Anagen to Telogen Ratio
Description
Anagen to Telogen Ratio, as assessed via Trichoscan
Time Frame
6 months
Title
Vellus Hair to Terminal Hair Ratio
Description
Vellus Hair to Terminal Hair Ratio, as assessed via Trichoscan
Time Frame
6 months
Title
Change in Dermatology Life Quality Index (DLQI)
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
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, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Coordinator
Phone
336-716-2903
Email
irichard@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Pichardo, MD
Organizational Affiliation
Wake Forest University School of Medicine, Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
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