NCT02393040

Brief Summary

The purpose of this study is to determine the efficacy of treatment with Platelet-rich plasma on Androgenetic alopecia (compared with placebo), between six months and baseline.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

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

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

1.5 years

First QC Date

March 3, 2015

Last Update Submit

March 18, 2015

Conditions

Androgenetic AlopeciaAlopeciaHair Loss

Keywords

AlopeciaAndrogenetic AlopeciaAlopecia, Male PatternHair lossPlatelet-Rich PlasmaAlopecia, Female Patternplacebodouble-blind

Outcome Measures

Primary Outcomes (1)

  • Determine the treatment efficacy by measuring hair regrowth score for each side of scalp.

    6 months

Secondary Outcomes (3)

  • Determine the treatment efficacy by measuring hair density for each side of scalp

    6 months

  • Determine the treatment efficacy by measuring anagen/telogen ratio for each side of scalp

    6 months

  • Global photographs of three areas of the scalp (evaluation of hair growth will be assessed by comparison of standardized images)

    6 months

Study Arms (1)

PRP/Saline

EXPERIMENTAL

PRP/Saline Briefly, for PRP preparation, approximately 18 mL of blood from each patient is drawn into a tube containing 3,8 % sodium citrate. The tubes were centrifuged at 450 g for 8 minutes, resulting in three basic layers: an erythrocyte layer at the bottom of the tube, a PRP layer in the middle, and a platelet-poor plasma (PPP) layer at the top of the tube. After removing the platelet-poor plasma (PPP) layer, the PRP is obtained, activated with 10 % calcium chloride. In the same patient, PRP will be injected to half-head and in the other half-head will be injected with saline solution (placebo). This study includes 4 visits: 3 visits (with 1-month interval) and 1 visit of follow-up (month 6).

Other: PRP/Saline

Interventions

PRP/SalineOTHER

PRP/Saline: Two groups were defined: group A and group B. Group A received treatment with PRP on the right half-head and placebo on the left half-head while group B received administration of PRP on left half-head and placebo on the right half-head. Same patient will be injected with PRP and a saline solution. Each patient will be injected on half-head.

Also known as: PRP, androgenetic alopecia, alopecia, hair Loss, placebo, saline
PRP/Saline

Eligibility Criteria

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

You may qualify if:

  • Patients ≥18 years and \< 65 years
  • Male patients with a clinical diagnosis of AGA (stage II to V according to the Hamilton-Norwood Scale)
  • Female patients with a clinical diagnosis of AGA (stage I to III according to Ludwig Classification)

You may not qualify if:

  • Patients with other types of alopecia, other than AGA
  • Fasting \< 3h prior of each injection
  • Use of nonsteroidal anti-inflammatory drugs one week before treatment.
  • Platelet count \< 150 000 μL
  • Alterations of coagulation
  • Heavy smokers (\> 20 cigarettes/day)
  • Medications: anticoagulants/ acetylsalicylic acid
  • Patient unable to accomplishing all fases of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional Catalunya

Barcelona, Barcelona, 08195, Spain

Location

MeSH Terms

Conditions

Alopecia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Rubina Alves, M.D.

    Specialist Dermatology, Universitat Internacional Catalunya

    PRINCIPAL INVESTIGATOR

  • Ramon Grimalt, M.D.; PhD

    Prof. Dermatology, Universitat Internacional Catalunya

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Dermatology, M.D.

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 19, 2015

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Study Completion

November 1, 2015

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

ES(1)