Androgenetic AlopeciaPRPNCT02393040
Study to Assess Efficacy of Platelet-Rich Plasma in Androgenetic Alopecia
A study testing PRP/Saline in people with Androgenetic Alopecia and Alopecia, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The purpose of this study is to determine the efficacy of treatment with Platelet-rich plasma on Androgenetic alopecia (compared with placebo), between six months and baseline. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Androgenetic Alopecia, Alopecia, Hair Loss
- What is being tested?
- PRP/Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Nov 2015
- 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
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Double Blind, Placebo Controlled Study to Assess the Efficacy of Platelet-Rich Plasma on the Treatment of Androgenetic Alopecia
The purpose of this study is to determine the efficacy of treatment with Platelet-rich plasma on Androgenetic alopecia (compared with placebo), between six months and baseline.
Read the detailed description
Androgenetic alopecia (AGA) is a non-scarring patterned alopecia, multifactorial and a genetic determined skin condition. This pathology is one of the most common forms of progressive hair loss. It's an increasingly frequent complaint of dermatology clinic patients and has a high impact psychologically.
The onset of AGA is gradual and when this pathology progresses, the anagen phase shortens and the telogen phase remains constant. As a result, more hairs are in the telogen phase, and the patient may notice an increase in hair shedding. This area varies from patient to patient and is usually most marked at the vertex in men while women with androgenetic alopecia generally lose hair diffusely over the crown. The incidence and prevalence of AGA increases with age.
Topical minoxidil and oral finasteride are the gold standard therapies for AGA and the only two drugs currently that have US Food and Drug Administration (FDA)-approved indications for the treatment of androgenetic alopecia. Minoxidil and finasteride are known to be effective medical treatments in AGA, especially during the initial grades.
PRP is a plasma concentrate reaped from the patient's whole blood that comprises predominantly platelets. Numerous growth factors (GFs) are present within platelet α granules. Some of the most important of these include platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), and insulin-like growth factor (IGF). This GFs stimulate cell proliferation and differentiation.
PRP was identified as having a beneficial effect on bone grafting with applications in oral and maxillofacial surgery, orthopedic and cardiac surgery. More recently, increasing interest is seen in the application of PRP in dermatology, for example, tissue regeneration, wound healing such and fat grafting. It has also been shown to promote hair survival and growth, both in vitro and in vivo.
The production of autologous PRP involves extraction of a specific volume of the patient's whole blood, which is then placed in an automated centrifuge to separate the layers of whole blood by their specific weight into 3 separate layers: (1) platelet-poor plasma, (2) platelet-rich plasma and (3) red blood cells.
The patients were divided into two groups (A and B): group A received treatment with PRP on the right half-head and the placebo on the left half-head, whereas group B received treatment with PRP on the left half-head and the placebo on the right half-head.
- Conditions
- Androgenetic Alopecia, Alopecia, Hair Loss
- Being tested
- PRP/Saline
- Keywords
- Alopecia, Androgenetic Alopecia, Alopecia, Male Pattern, Hair loss, Platelet-Rich Plasma, Alopecia, Female Pattern, placebo, double-blind
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP/SalineOther
Also called PRP, androgenetic alopecia, alopecia, hair Loss
PRP/Saline: Two groups were defined: group A and group B. Group A received treatment with PRP on the right half-head and placebo on the left half-head while group B received administration of PRP on left half-head and placebo on the right half-head.
Same patient will be injected with PRP and a saline solution. Each patient will be injected on half-head.
| Study group | Role | What they receive |
|---|---|---|
| PRP/Saline | Experimental | PRP/Saline
Briefly, for PRP preparation, approximately 18 mL of blood from each patient is drawn into a tube containing 3,8 % sodium citrate. The tubes were centrifuged at 450 g for 8 minutes, resulting in three basic layers: an erythrocyte layer at the bottom of the tube, a PRP layer in the middle, and a platelet-poor plasma (PPP) layer at the top of the tube. After removing the platelet-poor plasma (PPP) layer, the PRP is obtained, activated with 10 % calcium chloride.
In the same patient, PRP will be injected to half-head and in the other half-head will be injected with saline solution (placebo).
This study includes 4 visits: 3 visits (with 1-month interval) and 1 visit of follow-up (month 6). Receives: Other: PRP/Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the treatment efficacy by measuring hair regrowth score for each side of scalp.
Measured: 6 months
Secondary outcomes (3)
Determine the treatment efficacy by measuring hair density for each side of scalp
Determine the treatment efficacy by measuring mean hair density for each side of scalp using the trichogram analysis.
Measured: 6 months
Determine the treatment efficacy by measuring anagen/telogen ratio for each side of scalp
Determine the treatment efficacy by measuring anagen/telogen ratio for each side of scalp using the trichogram analysis.
Measured: 6 months
Global photographs of three areas of the scalp (evaluation of hair growth will be assessed by comparison of standardized images)
The evaluation of hair growth will be assessed by comparison of standardized images between baseline and 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionJul 2015 (estimated)
- Study completionNov 2015 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubina Alves, Universitat Internacional de Catalunya
- Investigators
- Rubina Alves, M.D., Principal investigator, Specialist Dermatology, Universitat Internacional CatalunyaRamon Grimalt, M.D.; PhD, Study director, Prof. Dermatology, Universitat Internacional Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393040
- Sponsor's protocol ID
- UICatalunya
- Acronym
- PRP
- Status last verified
- Mar 2015
- First submitted
- 3 Mar 2015
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Double Blind, Placebo Controlled Study to Assess the Efficacy of Platelet-Rich Plasma on the Treatment of Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT02393040
- Acronym / sponsor ID
- PRP / UICatalunya
- Conditions
- Androgenetic Alopecia, Alopecia, Hair Loss
- Keywords
- Alopecia, Androgenetic Alopecia, Alopecia, Male Pattern, Hair loss, Platelet-Rich Plasma, Alopecia, Female Pattern, placebo, double-blind
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 19 Mar 2015 (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.
The purpose of this study is to determine the efficacy of treatment with Platelet-rich plasma on Androgenetic alopecia (compared with placebo), between six months and baseline.
Detailed description
Androgenetic alopecia (AGA) is a non-scarring patterned alopecia, multifactorial and a genetic determined skin condition. This pathology is one of the most common forms of progressive hair loss. It's an increasingly frequent complaint of dermatology clinic patients and has a high impact psychologically.
The onset of AGA is gradual and when this pathology progresses, the anagen phase shortens and the telogen phase remains constant. As a result, more hairs are in the telogen phase, and the patient may notice an increase in hair shedding. This area varies from patient to patient and is usually most marked at the vertex in men while women with androgenetic alopecia generally lose hair diffusely over the crown. The incidence and prevalence of AGA increases with age.
Topical minoxidil and oral finasteride are the gold standard therapies for AGA and the only two drugs currently that have US Food and Drug Administration (FDA)-approved indications for the treatment of androgenetic alopecia. Minoxidil and finasteride are known to be effective medical treatments in AGA, especially during the initial grades.
PRP is a plasma concentrate reaped from the patient's whole blood that comprises predominantly platelets. Numerous growth factors (GFs) are present within platelet α granules. Some of the most important of these include platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), and insulin-like growth factor (IGF). This GFs stimulate cell proliferation and differentiation.
PRP was identified as having a beneficial effect on bone grafting with applications in oral and maxillofacial surgery, orthopedic and cardiac surgery. More recently, increasing interest is seen in the application of PRP in dermatology, for example, tissue regeneration, wound healing such and fat grafting. It has also been shown to promote hair survival and growth, both in vitro and in vivo.
The production of autologous PRP involves extraction of a specific volume of the patient's whole blood, which is then placed in an automated centrifuge to separate the layers of whole blood by their specific weight into 3 separate layers: (1) platelet-poor plasma, (2) platelet-rich plasma and (3) red blood cells.
The patients were divided into two groups (A and B): group A received treatment with PRP on the right half-head and the placebo on the left half-head, whereas group B received treatment with PRP on the left half-head and the placebo on the right half-head.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRP/Saline | Experimental | Other: PRP/SalinePRP/Saline Briefly, for PRP preparation, approximately 18 mL of blood from each patient is drawn into a tube containing 3,8 % sodium citrate. The tubes were centrifuged at 450 g for 8 minutes, resulting in three basic layers: an erythrocyte layer at the bottom of the tube, a PRP layer in the middle, and a platelet-poor plasma (PPP) layer at the top of the tube. After removing the platelet-poor plasma (PPP) layer, the PRP is obtained, activated with 10 % calcium chloride. In the same patient, PRP will be injected to half-head and in the other half-head will be injected with saline solution (placebo). This study includes 4 visits: 3 visits (with 1-month interval) and 1 visit of follow-up (month 6). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| PRP/SalineAlso: PRP, androgenetic alopecia, alopecia, hair LossPRP/Saline: Two groups were defined: group A and group B. Group A received treatment with PRP on the right half-head and placebo on the left half-head while group B received administration of PRP on left half-head and placebo on the right half-head. Same patient will be injected with PRP and a saline solution. Each patient will be injected on half-head. | Other | PRP/Saline |
Primary outcome
Determine the treatment efficacy by measuring hair regrowth score for each side of scalp.
Time frame: 6 months
3 secondary outcomes
Determine the treatment efficacy by measuring hair density for each side of scalp
Time frame: 6 months
Determine the treatment efficacy by measuring anagen/telogen ratio 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
Related trials for Androgenetic Alopecia
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Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
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Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
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Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
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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.
Rubina Alves, M.D. principal investigator
Specialist Dermatology, Universitat Internacional Catalunya
Ramon Grimalt, M.D.; PhD study director
Prof. Dermatology, Universitat Internacional Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP/Saline in people with Androgenetic Alopecia and Alopecia, run by Universitat Internacional de Catalunya at 1 site 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
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?
Determine the treatment efficacy by measuring hair regrowth score for each side of scalp. (time frame: 6 months). 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 19 Mar 2015.