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Evaluering af effektiviteten af ​​blodpladerig plasmaterapi i behandlingen af ​​androgen alopeci

4. november 2026 opdateret af: Wake Forest University Health Sciences

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

16

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27104
        • Wake Forest University Baptist Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Biologisk: Platelet-rich Plasma Left Side

Group A will receive PRP on left side of scalp and placebo (saline solution) on right side of scalp.
Eksperimentel: 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.
Biologisk: Platelet-rich Plasma Right Side

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Severity of Alopecia Tool (SALT) from baseline
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Hair Count (number of hairs/0.65cm^2)
Tidsramme: 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)
Tidsramme: 6 months

Change in Hair Density (number of hairs/cm^2), as assessed via Trichoscan
6 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Hair Diameter
Tidsramme: 6 months

Change in Hair Diameter, as assessed via Trichoscan
6 months
Anagen to Telogen Ratio
Tidsramme: 6 months

Anagen to Telogen Ratio, as assessed via Trichoscan
6 months
Vellus Hair to Terminal Hair Ratio
Tidsramme: 6 months

Vellus Hair to Terminal Hair Ratio, as assessed via Trichoscan
6 months
Change in Dermatology Life Quality Index (DLQI)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wake Forest University Health Sciences

Efterforskere

  • Ledende efterforsker: Rita Pichardo, MD, Wake Forest University School of Medicine, Department of Dermatology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. december 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

15. marts 2018

Først indsendt, der opfyldte QC-kriterier

15. marts 2018

Først opslået (Faktiske)

22. marts 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00045844

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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