Androgenetic AlopeciaNCT01885676
Plasma Rich in Growth Factors (PRGF-Endoret)in the Treatment of Androgenetic Alopecia
A study testing PRGF-Endoret and Saline Solution in people with Androgenetic Alopecia, run by Biotechnology Institute IMASD at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- PRGF-Endoret and Saline Solution
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesSpain
- Study dates
- 16 Sep 2013to 18 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
2 sites in 1 country.
Spain2 sites
Centro dermatológico estético
Alicante, 03014
Clínica Eduardo Anitua.
Vitoria-Gasteiz, Alava, 01007
About this study
Official title: A Pilot Randomized, Double-blind, Placebo-controlled Clinical Trial to Obtain Preliminary Data on Efficacy and Safety in the Application of PRGF-Endoret by Mesotherapy, in the Treatment of Male and Female Androgenetic Alopecia of Over 6 Months Duration.
- 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
- Being tested
- PRGF-Endoret, Saline Solution
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRGF-EndoretDevice
PRGF-Endoret mesotherapy micro injection.
Saline SolutionOther
Saline Solution mesotherapy micro injection
| Study group | Role | What they receive |
|---|---|---|
| PRGF-Endoret | Experimental | Not described Receives: Device: PRGF-Endoret |
| Saline Solution | Placebo comparator | Not described Receives: Other: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months post-treatment
Secondary outcomes (4)
Hair Width (micrometers)
Hair width will be measured for each treatment group
Measured: Basal, 1, 2, and 3 months post-treatment
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.
Measured: Basal, 1, 2, and 3 months post-treatment
Terminal Hair Density
Terminal hair density will be established for each one of the treatments
Measured: Before each one of the treatments and 1, 2 and 3 months post-treatment.
Vellous hair density
Vellous hair will be measured for each treatment group
Measured: Basal,1, 2 and 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study start16 Sep 2013
- Primary completionSep 2015
- Study completion18 Dec 2017
Why it stopped: As of 12/18/2017 notification of early closure of the trial due to lack of recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotechnology Institute IMASD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885676
- Sponsor's protocol ID
- BTI-01D-EC/12/ALO
- Status last verified
- Feb 2025
- First submitted
- 19 Jun 2013
- Last updated
- 6 Feb 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized, Double-blind, Placebo-controlled Clinical Trial to Obtain Preliminary Data on Efficacy and Safety in the Application of PRGF-Endoret by Mesotherapy, in the Treatment of Male and Female Androgenetic Alopecia of Over 6 Months Duration.
- ClinicalTrials.gov ID
- NCT01885676
- Acronym / sponsor ID
- BTI-01D-EC/12/ALO
- Conditions
- Androgenetic Alopecia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: As of 12/18/2017 notification of early closure of the trial due to lack of recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biotechnology Institute IMASDIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2013 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRGF-Endoret | Experimental | Device: PRGF-Endoret |
| Saline Solution | Placebo comparator | Other: Saline Solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRGF-EndoretPRGF-Endoret mesotherapy micro injection. | Device | PRGF-Endoret |
| Saline SolutionSaline Solution mesotherapy micro injection | Other | Saline Solution |
Primary outcome
Change from baseline in Hair density at three months (number of hairs per cm2)
Time frame: 3 months post-treatment
Hair density (number of hairs per cm2) will be measured for each treatment group
4 secondary outcomes
Hair Width (micrometers)
Time frame: Basal, 1, 2, and 3 months post-treatment
Anagen/telogen ratio
Time frame: Basal, 1, 2, and 3 months post-treatment
Terminal Hair Density
Time frame: Before each one of the treatments and 1, 2 and 3 months post-treatment.
Vellous hair density
Time frame: Basal,1, 2 and 3 months post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRGF-Endoret and Saline Solution in people with Androgenetic Alopecia, run by Biotechnology Institute IMASD at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Hair density at three months (number of hairs per cm2) (time frame: 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.