Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
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|ClinicalTrials.gov Identifier: NCT03474718|
Recruitment Status : Not yet recruiting
First Posted : March 22, 2018
Last Update Posted : February 2, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Androgenic Alopecia||Biological: Platelet-rich Plasma Left Side Biological: Platelet-rich Plasma Right Side||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|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.|
|Official Title:||Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia|
|Estimated Study Start Date :||March 2023|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||November 2023|
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.
- 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.
- 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
- 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
- Change in Hair Diameter [ Time Frame: 6 months ]Change in Hair Diameter, as assessed via Trichoscan
- Anagen to Telogen Ratio [ Time Frame: 6 months ]Anagen to Telogen Ratio, as assessed via Trichoscan
- Vellus Hair to Terminal Hair Ratio [ Time Frame: 6 months ]Vellus Hair to Terminal Hair Ratio, as assessed via Trichoscan
- 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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
|Contact: Research Coordinatorfirstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest University Baptist Health|
|Winston-Salem, North Carolina, United States, 27104|
|Principal Investigator:||Rita Pichardo, MD||Wake Forest University School of Medicine, Department of Dermatology|
|Responsible Party:||Wake Forest University Health Sciences|
|Other Study ID Numbers:||
|First Posted:||March 22, 2018 Key Record Dates|
|Last Update Posted:||February 2, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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|
platelet-rich plasma therapy
Pathological Conditions, Anatomical