Ocena skuteczności terapii osoczem bogatopłytkowym w leczeniu łysienia androgenowego
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Wczesna faza 1
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Research Coordinator
- Numer telefonu: 336-716-2903
- E-mail: irichard@wakehealth.edu
Lokalizacje studiów
-
-
North Carolina
-
Winston-Salem, North Carolina, Stany Zjednoczone, 27104
- Wake Forest University Baptist Health
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
Group A will receive PRP on left side of scalp and placebo (saline solution) on right side of scalp. |
|
Eksperymentalny: 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. |
Group B will receive PRP on right side of scalp and placebo (saline solution) on left side of scalp. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Severity of Alopecia Tool (SALT) from baseline
Ramy czasowe: 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. |
6 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Hair Count (number of hairs/0.65cm^2)
Ramy czasowe: 6 months
|
Change in Hair Count (number of hairs/0.65cm^2), as assessed via Trichoscan |
6 months
|
|
Change in Hair Density (number of hairs/cm^2)
Ramy czasowe: 6 months
|
Change in Hair Density (number of hairs/cm^2), as assessed via Trichoscan |
6 months
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Hair Diameter
Ramy czasowe: 6 months
|
Change in Hair Diameter, as assessed via Trichoscan |
6 months
|
|
Anagen to Telogen Ratio
Ramy czasowe: 6 months
|
Anagen to Telogen Ratio, as assessed via Trichoscan |
6 months
|
|
Vellus Hair to Terminal Hair Ratio
Ramy czasowe: 6 months
|
Vellus Hair to Terminal Hair Ratio, as assessed via Trichoscan |
6 months
|
|
Change in Dermatology Life Quality Index (DLQI)
Ramy czasowe: 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 |
6 months
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Rita Pichardo, MD, Wake Forest University School of Medicine, Department of Dermatology
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB00045844
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .