Androgenic Alopecia Clinical Trial
Official title:
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
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.
Status | Not yet recruiting |
Enrollment | 16 |
Est. completion date | December 2024 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Baptist Health | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Hair Diameter | Change in Hair Diameter, as assessed via Trichoscan | 6 months | |
Other | Anagen to Telogen Ratio | Anagen to Telogen Ratio, as assessed via Trichoscan | 6 months | |
Other | Vellus Hair to Terminal Hair Ratio | Vellus Hair to Terminal Hair Ratio, as assessed via Trichoscan | 6 months | |
Other | 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 |
6 months | |
Primary | 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. |
6 months | |
Secondary | Change in Hair Count (number of hairs/0.65cm^2) | Change in Hair Count (number of hairs/0.65cm^2), as assessed via Trichoscan | 6 months | |
Secondary | Change in Hair Density (number of hairs/cm^2) | Change in Hair Density (number of hairs/cm^2), as assessed via Trichoscan | 6 months |
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