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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03474718
Recruitment Status : Not yet recruiting
First Posted : March 22, 2018
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Androgenic Alopecia Biological: Platelet-rich Plasma Left Side Biological: Platelet-rich Plasma Right Side Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Second offsite investigator will assess the patient for clinical improvement and will be unaware of the patient's randomization assignment.
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. Change in Severity of Alopecia Tool (SALT) from baseline [ Time Frame: 6 months ]

    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 :
  1. Change in Hair Count (number of hairs/0.65cm^2) [ Time Frame: 6 months ]
    Change in Hair Count (number of hairs/0.65cm^2), as assessed via Trichoscan

  2. Change in Hair Density (number of hairs/cm^2) [ Time Frame: 6 months ]
    Change in Hair Density (number of hairs/cm^2), as assessed via Trichoscan


Other Outcome Measures:
  1. Change in Hair Diameter [ Time Frame: 6 months ]
    Change in Hair Diameter, as assessed via Trichoscan

  2. Anagen to Telogen Ratio [ Time Frame: 6 months ]
    Anagen to Telogen Ratio, as assessed via Trichoscan

  3. Vellus Hair to Terminal Hair Ratio [ Time Frame: 6 months ]
    Vellus Hair to Terminal Hair Ratio, as assessed via Trichoscan

  4. Change in Dermatology Life Quality Index (DLQI) [ Time Frame: 6 months ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474718


Contacts
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Contact: Leah A Cardwell, MD 313-716-1773 lcardwe@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest University Baptist Health
Winston-Salem, North Carolina, United States, 27104
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Rita Pichardo, MD Wake Forest University School of Medicine, Department of Dermatology
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03474718    
Other Study ID Numbers: IRB00045844
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Wake Forest University Health Sciences:
scalp
hair loss
platelet-rich plasma therapy
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical