Androgenetic AlopeciaPRP IN AGANCT04191005
Efficacy of Platelet-Rich Plasma Therapy for Androgenetic Alopecia: A Systematic Review and Meta-analysis
An observational study of Androgenetic Alopecia, run by Jasim Mohammed Alshammari at 1 site in Egypt.
Trial summary
assess the literature on PRP outcomes for AGA, with a focus on specific clinical outcomes in a comparative view, in accordance with PRISMA statement for reporting this meta-analysis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Androgenetic Alopecia
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2020to 30 Jan 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Data will be abstracted from every study in the form of a risk estimate and its 95% confidence interval (C1). Pooled risk estimate will be obtained by weighting each study by the inverse variance of the effect measure on algorithmic scale. This approach to pooling the results assumes that the study population being compared are similar and hence correspond to affixed effect analysis. The validity of pooling the risk estimate will be tested (test of homogeneity) using the chi-square test. A violation of this test implies that the studies being grouped differ from one another. In the presence of significant heterogeneity of the effect measure among studies being compared,
Who may be able to join
- 1- Search for and assess studies comparing local injections of PRP compared to any control for AGA.
- 2- Studies to be included in this review will be matched with predetermined criteria according to the PICOS (patients, intervention, comparator, outcomes, and study design) approach.
- 3- These studies must include patients with any age and stage of AGA , with a minimum of 10 patients, a minimum of 3 months follow -up.
- 4- Local injection of any autologous of PRP preparation into the scalp of AGA patients for treatment of AGA.
- 5- Measure the efficacy of PRP therapy for treatment of AGA.
Who cannot join
- Review, expert opinion, comments, letter to editor, case reports, studies on animals, conference reports will be excluded from the study.
- Studies of other types of alopecia (i.e., alopecia areata or cicatricial alopecia) or studies with less than 10 patients, follow up less than 3 months or with no outcome reported, will be excluded from the study.
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, Assiut Governorate, 71515 Assiut
Emad abdelrahem taha, professor, 01006462294 ext. egypt, Emadtaha76@yahoo.com
Manal mohamed darwish, ass.professor, 01005658116 ext. egypt, Manaldarwish@hotmail.com
About this study
assess the literature on PRP outcomes for AGA, with a focus on specific clinical outcomes in a comparative view, in accordance with PRISMA statement for reporting this meta-analysis
Read the detailed description
Androgenic alopecia (AGA) also known as androgenetic alopecia or male pattern baldness, is a common disorder that affects both men and women. Is one of the commonest reasons for dermatological consultation worldwide (1). It is characterized by progressive hair loss, especially of scalp hair, and has distinct patterns of loss in women versus men. AGA is an age-dependent disorder characterized by patterned hair loss. Based on the few prevalence data available, Know that by the age of 30 years about 30% of men will have AGA and that this will rise to about 50% by the age of 50 years and as many as 90% in their lifetime (2) , Although prevalence increases with age in all populations, thinning can begin as early as puberty (3). The hair thinning begins between the ages of 12 and 40 years in both sexes and approximately half the population expresses this trait to some degree before the age of 50 years (4). Androgentic alopecia is familial with a complex polygenic mode of inheritance (5) . Polymorphism of the androgen receptor gene, the 5 a reductase gene and 2 other, as yet unidentified genes on chromosomes 3 and 21 have been all been associated with premature balding (6). There is a family tendency towards androgenetic alopecia and it is thought to have a polygenic mode of inheritance. Alopecia causes major discomfort due to altered appearance with significant implications in daily living and possible leading to depression and anxiety symptoms with a significantly higher prevalence in AGA female compared with male subjects (7). Pathophysiology upon entry of testosterone into the hair follicle via dermal papilla's capillaries, binding occurs to the androgen receptors (ARs) either directly or after its conversion to dihydrotestosterone (DHT) (8). AGA is known to be mediated by the conversion of circulating androgens into DHT within the hair follicle .In the hair follicle cells, testosterone converts into the biologically more active metabolite; DHT, which is considered the key androgen required for the induction of AGA (9). This conversion is catalyzed by the enzyme 5α-reductase type-II. Binding of androgens to their ARs leads to conformational change of the AR-androgen complex which is then transported into the nucleus where it can bind to DNA which has distinctive binding sites: In most men, AGA involves the fronto temporal area and the vertex, following a pattern corresponding to the Hamilton- Norwood scale (10). In women, typically three patterns have been 1-Diffuse thinning of the crown region with preservation of the frontal hairline 2-Thinning and widening of the central part of the scalp with breach of frontal hairline, 3- Thinning associated with bitemporal recession (Hamilton-Norwood type, diagnostic evaluation form for AGA, including history, clinical evaluation like scalp and hair examination and diagnostic techniques and test (Pull test, Wash test), and clinical documentation . AGA can be treated medically, surgically or cosmetically (11) The most recommended treatment for AGA is composed of local minoxidil, hormonal therapy such as local and oral antiandrogens (12).
Platelet-rich plasma (PRP) is used as an innovative therapy in diverse fields including dentistry, surgery, orthopedics, dermatology and aesthetics (13). Currently, PRP preparation systems have FDA clearance for use in bone grafts and operative Orthopedics but off-label purposes such as for hair restoration have become increasingly common. PRP is a rich source of growth factors such as insulin-like growth factor 1 (IGF-1), platelet-derived growth factor (PDGF), transforming growth factor-b (TGF-b), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF) and fibroblast growth factor (FGF) which together can stimulate cell survival, proliferation, differentiation, vascularization and angiogenesis (14). Application of these growth factors to dermal papilla (DP) cells can lead to the initiation and prolongation of anagen phase in the hair follicle. Alpha granules within the platelets contain the growth factors and facilitate release at high concentrations, when the PRP preparation is activated. PRP is produced through cell separation by commercial kits or manual methods using a laboratory centrifuge and then injected into androgen-dependent areas of the scalp ( 15). With more hair restoration clinics choosing to offer PRP therapy, data on treatment efficacy have begun to accumulate. The AGA application remains in the early stages as treatment protocols are still being refined. At this time, PRP has been used in combination with hair transplant surgery and as an injectable therapy alone. Furthermore, diverse methods are reported as activators can be used to stimulate growth factor release; additional components such as leukocytes and dalteparin and protamine micro particles may be included to boost results; and quantity and frequency of treatments have varied widely (16).
The conduction of a meta-analysis provides systematic assessment of previous research studies to derive conclusions about that body of research. Outcomes from a meta-analysis may include a more precise estimate of the effect of treatment than any individual study .
- Conditions
- Androgenetic Alopecia
- Medical subject headings
- Alopecia
What is being measured
The primary outcome is the main question the study is designed to answer.
number of hair per square centimeter
measure the number of hairs per square centimeter.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start7 Jan 2020 (estimated)
- Primary completion20 Jan 2020 (estimated)
- Study completion30 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jasim Mohammed Alshammari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jasim Mohammed Alshammari, Assiut University
- Investigators
- Manal mohamed Darwish, ass.professor, Study director, community medicineRofaida refaat Shahata, doctor, Principal investigator, dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191005
- Sponsor's protocol ID
- PRP in Androgentic Alopecia
- Acronym
- PRP IN AGA
- Status last verified
- Jan 2020
- First submitted
- 4 Dec 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Severi G, Sinclair R, Hopper JL, English DR, McCredie MR, Boyle P, Giles GG. Androgenetic alopecia in men aged 40-69 years: prevalence and risk factors. Br J Dermatol. 2003 Dec;149(6):1207-13. doi: 10.1111/j.1365-2133.2003.05565.x.
PubMed 14674898Varothai S, Bergfeld WF. Androgenetic alopecia: an evidence-based treatment update. Am J Clin Dermatol. 2014 Jul;15(3):217-30. doi: 10.1007/s40257-014-0077-5.
PubMed 24848508Norwood OT. Male pattern baldness: classification and incidence. South Med J. 1975 Nov;68(11):1359-65. doi: 10.1097/00007611-197511000-00009.
PubMed 1188424Stevens J, Khetarpal S. Platelet-rich plasma for androgenetic alopecia: A review of the literature and proposed treatment protocol. Int J Womens Dermatol. 2018 Sep 21;5(1):46-51. doi: 10.1016/j.ijwd.2018.08.004. eCollection 2019 Feb.
PubMed 30809579
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet-Rich Plasma Therapy for Androgenetic Alopecia: A Systematic Review and Meta-analysis
- ClinicalTrials.gov ID
- NCT04191005
- Acronym / sponsor ID
- PRP IN AGA / PRP in Androgentic Alopecia
- Conditions
- Androgenetic Alopecia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Jasim Mohammed AlshammariUniversity, hospital or other
- Study start
- 7 Jan 2020 (estimated)
- Primary completion
- 20 Jan 2020 (estimated)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 9 Dec 2019 (actual)
- 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.
assess the literature on PRP outcomes for AGA, with a focus on specific clinical outcomes in a comparative view, in accordance with PRISMA statement for reporting this meta-analysis
Detailed description
Androgenic alopecia (AGA) also known as androgenetic alopecia or male pattern baldness, is a common disorder that affects both men and women. Is one of the commonest reasons for dermatological consultation worldwide (1). It is characterized by progressive hair loss, especially of scalp hair, and has distinct patterns of loss in women versus men. AGA is an age-dependent disorder characterized by patterned hair loss. Based on the few prevalence data available, Know that by the age of 30 years about 30% of men will have AGA and that this will rise to about 50% by the age of 50 years and as many as 90% in their lifetime (2) , Although prevalence increases with age in all populations, thinning can begin as early as puberty (3). The hair thinning begins between the ages of 12 and 40 years in both sexes and approximately half the population expresses this trait to some degree before the age of 50 years (4). Androgentic alopecia is familial with a complex polygenic mode of inheritance (5) . Polymorphism of the androgen receptor gene, the 5 a reductase gene and 2 other, as yet unidentified genes on chromosomes 3 and 21 have been all been associated with premature balding (6). There is a family tendency towards androgenetic alopecia and it is thought to have a polygenic mode of inheritance. Alopecia causes major discomfort due to altered appearance with significant implications in daily living and possible leading to depression and anxiety symptoms with a significantly higher prevalence in AGA female compared with male subjects (7). Pathophysiology upon entry of testosterone into the hair follicle via dermal papilla's capillaries, binding occurs to the androgen receptors (ARs) either directly or after its conversion to dihydrotestosterone (DHT) (8). AGA is known to be mediated by the conversion of circulating androgens into DHT within the hair follicle .In the hair follicle cells, testosterone converts into the biologically more active metabolite; DHT, which is considered the key androgen required for the induction of AGA (9). This conversion is catalyzed by the enzyme 5α-reductase type-II. Binding of androgens to their ARs leads to conformational change of the AR-androgen complex which is then transported into the nucleus where it can bind to DNA which has distinctive binding sites: In most men, AGA involves the fronto temporal area and the vertex, following a pattern corresponding to the Hamilton- Norwood scale (10). In women, typically three patterns have been 1-Diffuse thinning of the crown region with preservation of the frontal hairline 2-Thinning and widening of the central part of the scalp with breach of frontal hairline, 3- Thinning associated with bitemporal recession (Hamilton-Norwood type, diagnostic evaluation form for AGA, including history, clinical evaluation like scalp and hair examination and diagnostic techniques and test (Pull test, Wash test), and clinical documentation . AGA can be treated medically, surgically or cosmetically (11) The most recommended treatment for AGA is composed of local minoxidil, hormonal therapy such as local and oral antiandrogens (12).
Platelet-rich plasma (PRP) is used as an innovative therapy in diverse fields including dentistry, surgery, orthopedics, dermatology and aesthetics (13). Currently, PRP preparation systems have FDA clearance for use in bone grafts and operative Orthopedics but off-label purposes such as for hair restoration have become increasingly common. PRP is a rich source of growth factors such as insulin-like growth factor 1 (IGF-1), platelet-derived growth factor (PDGF), transforming growth factor-b (TGF-b), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF) and fibroblast growth factor (FGF) which together can stimulate cell survival, proliferation, differentiation, vascularization and angiogenesis (14). Application of these growth factors to dermal papilla (DP) cells can lead to the initiation and prolongation of anagen phase in the hair follicle. Alpha granules within the platelets contain the growth factors and facilitate release at high concentrations, when the PRP preparation is activated. PRP is produced through cell separation by commercial kits or manual methods using a laboratory centrifuge and then injected into androgen-dependent areas of the scalp ( 15). With more hair restoration clinics choosing to offer PRP therapy, data on treatment efficacy have begun to accumulate. The AGA application remains in the early stages as treatment protocols are still being refined. At this time, PRP has been used in combination with hair transplant surgery and as an injectable therapy alone. Furthermore, diverse methods are reported as activators can be used to stimulate growth factor release; additional components such as leukocytes and dalteparin and protamine micro particles may be included to boost results; and quantity and frequency of treatments have varied widely (16).
The conduction of a meta-analysis provides systematic assessment of previous research studies to derive conclusions about that body of research. Outcomes from a meta-analysis may include a more precise estimate of the effect of treatment than any individual study .
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Data will be abstracted from every study in the form of a risk estimate and its 95% confidence interval (C1). Pooled risk estimate will be obtained by weighting each study by the inverse variance of the effect measure on algorithmic scale. This approach to pooling the results assumes that the study population being compared are similar and hence correspond to affixed effect analysis. The validity of pooling the risk estimate will be tested (test of homogeneity) using the chi-square test. A violation of this test implies that the studies being grouped differ from one another. In the presence of significant heterogeneity of the effect measure among studies being compared,
Key inclusion criteria (5 listed)
- 1- Search for and assess studies comparing local injections of PRP compared to any control for AGA.
- 2- Studies to be included in this review will be matched with predetermined criteria according to the PICOS (patients, intervention, comparator, outcomes, and study design) approach.
- 3- These studies must include patients with any age and stage of AGA , with a minimum of 10 patients, a minimum of 3 months follow -up.
- 4- Local injection of any autologous of PRP preparation into the scalp of AGA patients for treatment of AGA.
- 5- Measure the efficacy of PRP therapy for treatment of AGA.
Key exclusion criteria (3 listed)
- Review, expert opinion, comments, letter to editor, case reports, studies on animals, conference reports will be excluded from the study.
- Studies of other types of alopecia (i.e., alopecia areata or cicatricial alopecia) or studies with less than 10 patients, follow up less than 3 months or with no outcome reported, will be excluded from the study.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of hair per square centimeter
Time frame: one year
measure the number of hairs per square centimeter.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Background: PubMed 14674898Severi G, Sinclair R, Hopper JL, English DR, McCredie MR, Boyle P, Giles GG. Androgenetic alopecia in men aged 40-69 years: prevalence and risk factors. Br J Dermatol. 2003 Dec;149(6):1207-13. doi: 10.1111/j.1365-2133.2003.05565.x.
- Background: PubMed 24848508Varothai S, Bergfeld WF. Androgenetic alopecia: an evidence-based treatment update. Am J Clin Dermatol. 2014 Jul;15(3):217-30. doi: 10.1007/s40257-014-0077-5.
- Background: PubMed 1188424Norwood OT. Male pattern baldness: classification and incidence. South Med J. 1975 Nov;68(11):1359-65. doi: 10.1097/00007611-197511000-00009.
- Background: PubMed 30809579Stevens J, Khetarpal S. Platelet-rich plasma for androgenetic alopecia: A review of the literature and proposed treatment protocol. Int J Womens Dermatol. 2018 Sep 21;5(1):46-51. doi: 10.1016/j.ijwd.2018.08.004. eCollection 2019 Feb.
- Stevens, J., \& Khetarpal, S. (2018). Platelet-rich plasma for androgenetic alopecia: A review of the literature and proposed treatment protocol. International journal of women's dermatology.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Manal mohamed Darwish, ass.professor study director
community medicine
Rofaida refaat Shahata, doctor principal investigator
dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Androgenetic Alopecia, run by Jasim Mohammed Alshammari at 1 site in Egypt.
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 5 inclusion and 3 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 7 Jan 2020. 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 Egypt. 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?
Contact jasim mohamed alshammari, MSc (01010730962 ext. Assiut U, drjasimmohamed12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of hair per square centimeter (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04191005, which also lists 4 linked publications.
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 7 Jan 2020.