|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
30 March 2015 |
|
Main ID: |
NCT02393040 |
|
Date of registration:
|
03/03/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Study to Assess Efficacy of Platelet-Rich Plasma in Androgenetic Alopecia
PRP |
|
Scientific title:
|
A Prospective Double Blind, Placebo Controlled Study to Assess the Efficacy of Platelet-Rich Plasma on the Treatment of Androgenetic Alopecia |
|
Date of first enrolment:
|
January 2014 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT02393040 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Spain
| | | | | | | |
|
Contacts
|
|
Name:
|
Rubina Alves, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Specialist Dermatology, Universitat Internacional Catalunya |
|
|
Name:
|
Ramon Grimalt, M.D.; PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Prof. Dermatology, Universitat Internacional Catalunya |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Hair Loss
|
|
Alopecia
|
|
Androgenetic Alopecia
|
|
Intervention(s)
|
|
Other: PRP/Saline
|
|
Primary Outcome(s)
|
|
Determine the treatment efficacy by measuring hair regrowth score for each side of scalp.
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
Determine the treatment efficacy by measuring anagen/telogen ratio for each side of scalp
[Time Frame: 6 months]
|
|
Determine the treatment efficacy by measuring hair density for each side of scalp
[Time Frame: 6 months]
|
|
Global photographs of three areas of the scalp (evaluation of hair growth will be assessed by comparison of standardized images)
[Time Frame: 6 months]
|
|
Secondary ID(s)
|
|
UICatalunya
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|