WrinklesPhase 1WIPESNCT01078493
Wrinkle Injection With Autologous Platelet Rich Plasma Study
A Phase 1 study testing MyCells® (injection of platelet rich plasma) in people with Wrinkles, run by Novena Medical Center at 1 site in Singapore.
Trial summary
Wrinkles result from imperfect repair of the dermal layer resulting in loss of collagen commonly due to ageing, smoking and sun exposure. Platelet rich plasma (PRP) contains a host of growth factors, which have been used in other clinical trials for various medical conditions such as tendonitis, and also in surgery… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkles
- What is being tested?
- MyCells® (injection of platelet rich plasma)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 0 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2010to May 2012
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults more than 21 years of age
- Dis-satisfied or anxious about facial wrinkles (total wrinkle length more than 1cm)
Who cannot join
- Pregnant women.
- Psychiatric patients.
- Known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia
- Anticoagulants(eg.aspirin, warfarin)
- Had other wrinkle therapy for less than a month.(laser, peels, injections)
- Had facelift surgery for less than a year.
- Diseased states such as organ failure, severe anaemia, cancer, acute/chronic infections.
- Involved in personal litigation against an aesthetic service provider
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Life Source Medical Centre @ Novena Medical Center
Singapore, Singapore, 307506
About this study
Official title: Phase 1 Study of Intradermal Injection of Autologous Platelet Rich Plasma for Facial Wrinkles
Wrinkles result from imperfect repair of the dermal layer resulting in loss of collagen commonly due to ageing, smoking and sun exposure. Platelet rich plasma (PRP) contains a host of growth factors, which have been used in other clinical trials for various medical conditions such as tendonitis, and also in surgery such as the surgical repair of facial defects. Results from these clinical trials suggest that PRP helps in collagen formation and organisation to promote healing of tissues. This study attempts to document the clinical effects of intradermal injection of PRP on wrinkles.
Read the detailed description
10 selected participants will have 10 ml of blood removed for platelet extraction with MyCells®. The resulting Platelet rich plasma will be injected intradermally into the facial wrinkles.
- Conditions
- Wrinkles
- Being tested
- MyCells® (injection of platelet rich plasma)
- Keywords
- Platelet rich plasma, PRP, wrinkles, MyCells®, CREATE, Life Source Medical Centre, Dr Tan Kok leong
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyCells® (injection of platelet rich plasma)Device
Also called MyCells autologous platelet preparation system
PRP contains at least 1,000,000 platelets per mm3 or 2-6 times the native concentration of whole blood at a pH of 6.5 to 6.7
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Wrinkle Length
All visible wrinkles are measured and the length is summed up to give the Total Wrinkle Length. Comparison of pre treatment and post treatment Total Wrinkle Length will be studied.
Measured: 3 months
Secondary outcomes (1)
Side effect / Adverse Event
Side Effects / Adverse Events to be monitored include allergic reaction, nerve injury and cavernous sinus thrombosis.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completionMay 2012
Why it stopped: Protocol revision necessary.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novena Medical Center
- Sponsor type
- Research network
- Investigators
- Kok Leong Tan, MBBS, Principal investigator, Life Source Medical Centre @ Novena Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078493
- Sponsor's protocol ID
- CTC1000031
- Acronym
- WIPES
- Status last verified
- Sep 2016
- First submitted
- 27 Feb 2010
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Intradermal Injection of Autologous Platelet Rich Plasma for Facial Wrinkles
- ClinicalTrials.gov ID
- NCT01078493
- Acronym / sponsor ID
- WIPES / CTC1000031
- Conditions
- Wrinkles
- Keywords
- Platelet rich plasma, PRP, wrinkles, MyCells®, CREATE, Life Source Medical Centre, Dr Tan Kok leong
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol revision necessary.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novena Medical CenterResearch network
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Mar 2010 (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.
Wrinkles result from imperfect repair of the dermal layer resulting in loss of collagen commonly due to ageing, smoking and sun exposure. Platelet rich plasma (PRP) contains a host of growth factors, which have been used in other clinical trials for various medical conditions such as tendonitis, and also in surgery such as the surgical repair of facial defects. Results from these clinical trials suggest that PRP helps in collagen formation and organisation to promote healing of tissues. This study attempts to document the clinical effects of intradermal injection of PRP on wrinkles.
Detailed description
10 selected participants will have 10 ml of blood removed for platelet extraction with MyCells®. The resulting Platelet rich plasma will be injected intradermally into the facial wrinkles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults more than 21 years of age
- Dis-satisfied or anxious about facial wrinkles (total wrinkle length more than 1cm)
Key exclusion criteria (8 listed)
- Pregnant women.
- Psychiatric patients.
- Known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia
- Anticoagulants(eg.aspirin, warfarin)
- Had other wrinkle therapy for less than a month.(laser, peels, injections)
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 |
|---|---|---|
| MyCells® (injection of platelet rich plasma)Also: MyCells autologous platelet preparation systemPRP contains at least 1,000,000 platelets per mm3 or 2-6 times the native concentration of whole blood at a pH of 6.5 to 6.7 | Device | – |
Primary outcome
Total Wrinkle Length
Time frame: 3 months
All visible wrinkles are measured and the length is summed up to give the Total Wrinkle Length. Comparison of pre treatment and post treatment Total Wrinkle Length will be studied.
1 secondary outcome
Side effect / Adverse Event
Time frame: 3 months
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 26 Sep 2016.
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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.
Kok Leong Tan, MBBS principal investigator
Life Source Medical Centre @ Novena Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MyCells® (injection of platelet rich plasma) in people with Wrinkles, run by Novena Medical Center at 1 site in Singapore.
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 2 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: withdrawn, as of the sponsor's last update on 26 Sep 2016. 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 Singapore. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total Wrinkle Length (time frame: 3 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 26 Sep 2016.