Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01885676
Other study ID # BTI-01D-EC/12/ALO
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 19, 2013
Last updated June 24, 2013

Study information

Verified date June 2013
Source Biotechnology Institute IMASD
Contact Eduardo Anitua, MD, DDS, PhD
Phone +34 945160650
Email eduardoanitua@eduardoanitua.com
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
PRGF-Endoret
PRGF-Endoret mesotherapy micro injection.
Other:
Saline Solution
Saline Solution mesotherapy micro injection

Locations

Country Name City State
Spain Centro dermatológico estético Alicante
Spain Clínica Eduardo Anitua. Vitoria Alava

Sponsors (1)

Lead Sponsor Collaborator
Biotechnology Institute IMASD

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Hair Width (micrometers) Hair width will be measured for each treatment group Basal, 1, 2, and 3 months post-treatment No
Secondary Anagen/telogen ratio Hair cycle has different phases. Two of the most important are anagen (active growth phase of hair follicles) and telogen (resting phase of the hair follicle). This secondary outcome measure allows to measure the efficacy of the PRGF-Endoret treatment. Basal, 1, 2, and 3 months post-treatment No
Secondary Terminal Hair Density Terminal hair density will be established for each one of the treatments Before each one of the treatments and 1, 2 and 3 months post-treatment. No
Secondary Vellous hair density Vellous hair will be measured for each treatment group Basal,1, 2 and 3 months post-treatment No
See also
  Status Clinical Trial Phase
Completed NCT02591355 - Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment N/A
Withdrawn NCT03852992 - Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia Phase 2
Recruiting NCT06239207 - Efficacy and Safety of Exosomes Versus Platelet Rich Plasma in Patients of Androgenetic Alopecia Phase 2
Completed NCT04945226 - A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001 Phase 1/Phase 2
Completed NCT01437163 - Treatment of Androgenetic Alopecia in Males and Females N/A
Completed NCT01548066 - The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss Phase 2
Completed NCT01226459 - Clinical Trial in Females for Female Pattern Hair Loss Phase 3
Recruiting NCT06118866 - A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia Phase 2
Completed NCT06149221 - Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss N/A
Withdrawn NCT04882969 - Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia N/A
Completed NCT01231607 - Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia Phase 3
Completed NCT04446429 - Anti-Androgen Treatment for COVID-19 N/A
Completed NCT02729415 - Point-of-Care Adipose-derived Cells for Hair Growth N/A
Completed NCT02279823 - A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia Phase 2
Not yet recruiting NCT01227031 - Pharmacogenomic Study of Androgenetic Alopecia N/A
Completed NCT00981461 - Treatment of Androgenetic Alopecia in Females, 9 Beam N/A
Completed NCT01451021 - A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss Phase 2
Completed NCT00151515 - A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss Phase 3
Completed NCT03694067 - Androgenetic Alopecia and the JAK-STAT Pathway
Completed NCT03689452 - The Effect of Platelet Rich Plasma on Non-scarring Alopecia N/A