Plasma Rich in Growth Factors (PRGF-Endoret)in the Treatment of Androgenetic Alopecia

B

Biotechnology Institute IMASD

Status

Unknown

Conditions

Androgenetic Alopecia

Treatments

Other: Saline Solution
Device: PRGF-Endoret

Study type

Interventional

Funder types

Industry

Identifiers

NCT01885676
BTI-01D-EC/12/ALO

Details and patient eligibility

About

Androgenetic alopecia (AGA) or common baldness is the most common cause of hair loss in both men and women and is caused by the action of androgens in genetically predisposed individuals. This clinical trial was designed to evaluate the efficacy and safety of using a preparation of autologous plasma rich in growth factors (PRGF-Endoret) in the treatment of androgenetic alopecia.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Androgenetic alopecia according to the following scales:

  • Men: Hamilton/Norwood Scale: grades II-VI
  • Women: Ludwig Scale grades I-II.
  • Possibility of follow-up during the study

Exclusion criteria

  • No androgenetic alopecia
  • Telogen and anagen effluvium
  • Active inflammation or infection in the intervention area
  • Presence of active systemic infections.
  • Background of cancerous or precancerous lesions.
  • Background of connective or rheumatic diseases.
  • Suffering from any serious blood disorders.
  • To have undergone treatments for alopecia in the previous 6 months.
  • Previous hair implants
  • Intake of drugs that affect hair loss.
  • Be undergoing immunosuppressive therapy and/or anticoagulants.
  • Known intolerance to mesotherapy.
  • Taking contraceptives containing cyproterone acetate.
  • Pregnancy
  • In general, any limitations that would prevent the proper application of both treatments and the right monitoring of the efficacy variables.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 2 patient groups, including a placebo group

PRGF-Endoret
Experimental group
Treatment:
Device: PRGF-Endoret
Saline Solution
Placebo Comparator group
Treatment:
Other: Saline Solution

Trial contacts and locations

2

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Central trial contact

Eduardo Anitua, MD, DDS, PhD

Data sourced from clinicaltrials.gov

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