Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/13/2019 |
| Start Date: | April 2019 |
| End Date: | June 2020 |
| Contact: | Leah A Cardwell, MD |
| Email: | lcardwe@wakehealth.edu |
| Phone: | 313-716-1773 |
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.
product which is from the participant's own body, in the treatment of androgenic alopecia
(also known as male pattern hair loss) in females.
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.
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.
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
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