Androgenetic AlopeciaPhase 1/2NCT01644422
Study To Determine Safety & Efficacy Of Autologous Human Platelet Lysate in Androgenetic Alopecia After Hair Transplant
A Phase 1/2 study testing Autologous Human Platelet Lysate and Standard hair follicle transplant in people with Androgenetic Alopecia, run by Kasiak Research Pvt. Ltd. at 1 site in India.
Trial summary
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia undergoing hair transplantation. The study is being conducted at 2 centers in India. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Autologous Human Platelet Lysate and Standard hair follicle transplant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2012to Nov 2012
- Phase
- Phase 1/2
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male subjects, aged between 18 to 50 years (both inclusive) and in general good health
- Subjects willing to refrain from other AGA treatments during the entire study duration
- Subjects who are willing to give informed consent and adhere to the study protocol
Who cannot join
- Subjects aged <18 or > 50 years
- Subjects with dermatological disorder of scalp that might interfere with study evaluation
- Subjects on Anti-coagulant therapy
- Subjects with clinically significant medical or psychiatric disease as determined by the investigator.
- Subjects unwilling to or unable to comply with the study protocol.
- Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or participating in another trial in the past 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate Safety & Efficacy Of Autologous Human Platelet Lysate For Treatment Of Androgenetic Alopecia In Patients Undergoing Hair Transplant
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia undergoing hair transplantation. The study is being conducted at 2 centers in India. The primary endpoints are Increase in Hair Follicle viability after transplant, Improvement in Caliber \& Density of hair and Improvement in Photographic assessment from randomization to end of study. The secondary endpoints are Physicians and Patients self assessment score.
- Conditions
- Androgenetic Alopecia
- Being tested
- Autologous Human Platelet Lysate, Standard hair follicle transplant
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Human Platelet LysateBiological
Study arm A subjects will receive hair follicles transplants that are dipped in HPL before transplant
Autologous Human Platelet LysateBiological
Study arm B subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection
Standard hair follicle transplantOther
Control arm subject will receive Standard hair follicle transplant
| Study group | Role | What they receive |
|---|---|---|
| Study arm A | Other | Subjects will receive hair follicles transplants that are dipped in HPL before transplant Receives: Biological: Autologous Human Platelet Lysate |
| Study arm B | Other | Subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection one week after transplant Receives: Biological: Autologous Human Platelet Lysate |
| Control arm C | Other | Subject will receive Standard hair follicle transplant Receives: Other: Standard hair follicle transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Calibre & Density of Hair as assessed by Folliscope
Measured: Day 0, Month 2, End of Study - Month 4
Secondary outcomes (1)
Photographic assessment
Measured: Day 0, Month 1, Month 2, Month 3, End of Study - Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2012 (estimated)
- Study completionNov 2012 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasiak Research Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajendarsingh Rajput, Dr., Principal investigator, Dr. Rajesh Rajput Hair RestoreSandeep Sattur, Dr., Principal investigator, Hairrevive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644422
- Sponsor's protocol ID
- KRPL/HPL-AGA/11-12/001B
- Status last verified
- Jul 2012
- First submitted
- 17 Jul 2012
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate Safety & Efficacy Of Autologous Human Platelet Lysate For Treatment Of Androgenetic Alopecia In Patients Undergoing Hair Transplant
- ClinicalTrials.gov ID
- NCT01644422
- Acronym / sponsor ID
- KRPL/HPL-AGA/11-12/001B
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kasiak Research Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 19 Jul 2012 (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.
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia undergoing hair transplantation. The study is being conducted at 2 centers in India. The primary endpoints are Increase in Hair Follicle viability after transplant, Improvement in Caliber \& Density of hair and Improvement in Photographic assessment from randomization to end of study. The secondary endpoints are Physicians and Patients self assessment score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study arm A | Other | Biological: Autologous Human Platelet LysateSubjects will receive hair follicles transplants that are dipped in HPL before transplant |
| Study arm B | Other | Biological: Autologous Human Platelet LysateSubjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection one week after transplant |
| Control arm C | Other | Other: Standard hair follicle transplantSubject will receive Standard hair follicle transplant |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male subjects, aged between 18 to 50 years (both inclusive) and in general good health
- Subjects willing to refrain from other AGA treatments during the entire study duration
- Subjects who are willing to give informed consent and adhere to the study protocol
Key exclusion criteria (6 listed)
- Subjects aged <18 or > 50 years
- Subjects with dermatological disorder of scalp that might interfere with study evaluation
- Subjects on Anti-coagulant therapy
- Subjects with clinically significant medical or psychiatric disease as determined by the investigator.
- Subjects unwilling to or unable to comply with the study protocol.
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 |
|---|---|---|
| Autologous Human Platelet LysateStudy arm A subjects will receive hair follicles transplants that are dipped in HPL before transplant | Biological | Study arm A |
| Autologous Human Platelet LysateStudy arm B subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection | Biological | Study arm B |
| Standard hair follicle transplantControl arm subject will receive Standard hair follicle transplant | Other | Control arm C |
Primary outcome
Improvement in Calibre & Density of Hair as assessed by Folliscope
Time frame: Day 0, Month 2, End of Study - Month 4
1 secondary outcome
Photographic assessment
Time frame: Day 0, Month 1, Month 2, Month 3, End of Study - Month 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
Related trials for Androgenetic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
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.
Rajendarsingh Rajput, Dr. principal investigator
Dr. Rajesh Rajput Hair Restore
Sandeep Sattur, Dr. principal investigator
Hairrevive
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous Human Platelet Lysate and Standard hair follicle transplant in people with Androgenetic Alopecia, run by Kasiak Research Pvt. Ltd. at 1 site in India.
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 6 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 25 Jul 2012. 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 India. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement in Calibre & Density of Hair as assessed by Folliscope (time frame: Day 0, Month 2, End of Study - Month 4). 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 25 Jul 2012.