NCT02074943

Brief Summary

The investigators plan to conduct a clinical trial to assess the effects and safety of platelet rich plasma on androgenetic alopecia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

1.2 years

First QC Date

February 25, 2014

Last Update Submit

December 10, 2014

Conditions

Keywords

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

  • The degree of hair regrowth based on the hair regrowth score (RGS) for each side of scalp.

    16 weeks

Secondary Outcomes (1)

  • Changes in hair count and caliber. Changes in hair count and caliber

    16 weeks

Study Arms (1)

PRP/Saline

EXPERIMENTAL

Same patient will be injected with PRP and normal saline. Each one will be inject on half head.

Biological: PRP

Interventions

PRPBIOLOGICAL

PRP will be inject to half head. The other half will be injected with normal saline.

PRP/Saline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females in good general health, ages 18-70.
  • Patients with mild to moderate AGA (Ludwig alopecia score I and II, and the Hamilton-Norwood score 1 to 4).

You may not qualify if:

  • Patients who received treatments for AGA within the last 3 months.
  • Patients who have active or history of malignancies.
  • Patients with platelets disorders, anemia and or bleeding disorders.
  • Women who are pregnant or breast-feeding.
  • Un-cooperative patients or patients who are unable to understand the protocol or give informed consent.
  • Patients who are known to be HIV, hepatitis B or C positive or otherwise immunocompromised.
  • Subjects who have active skin disease or skin infection at the intended treatment area.
  • Patients on non-steroidal anti-inflammatory medications.
  • Patients with a propensity for keloids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Skin Care Center, Vancouver General Hospital

Vancouver, V5Z 4E8, Canada

RECRUITING

Related Publications (1)

  • Siah TW, Guo H, Chu T, Santos L, Nakamura H, Leung G, Shapiro J, McElwee KJ. Growth factor concentrations in platelet-rich plasma for androgenetic alopecia: An intra-subject, randomized, blinded, placebo-controlled, pilot study. Exp Dermatol. 2020 Mar;29(3):334-340. doi: 10.1111/exd.14074. Epub 2020 Feb 7.

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jerry Shapiro, MD

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jerry Shapiro, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 25, 2014

First Posted

February 28, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

December 11, 2014

Record last verified: 2014-12

Locations