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

NCT01885676 | Withdrawn

• 1 other identifier: BTI-01D-EC/12/ALO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

• 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.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Hair density at three months (number of hairs per cm2)

  Hair density (number of hairs per cm2) will be measured for each treatment group

  3 months post-treatment

Secondary Outcomes (4)

• Hair Width (micrometers)

  Basal, 1, 2, and 3 months post-treatment

• Anagen/telogen ratio

  Basal, 1, 2, and 3 months post-treatment

• Terminal Hair Density

  Before each one of the treatments and 1, 2 and 3 months post-treatment.

• Vellous hair density

  Basal,1, 2 and 3 months post-treatment

Study Arms (2)

PRGF-Endoret

EXPERIMENTAL

Device: PRGF-Endoret

Saline Solution

PLACEBO COMPARATOR

Other: Saline Solution

Interventions

PRGF-Endoret DEVICE

PRGF-Endoret mesotherapy micro injection.

PRGF-Endoret

Saline Solution OTHER

Saline Solution mesotherapy micro injection

Saline Solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotechnology Institute IMASD: lead

Study Sites (2)

Clínica Eduardo Anitua.

Vitoria-Gasteiz, Alava, 01007, Spain

Location

Centro dermatológico estético

Alicante, 03014, Spain

Location

MeSH Terms

Conditions

Alopecia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 25, 2013
• Study Start: September 16, 2013
• Primary Completion: September 1, 2015
• Study Completion: December 18, 2017
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

ES (2)