Facial Wrinkles (Nasolabial Folds)Phase 1/2NCT01644461
A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Facial Wrinkles(Nasolabial Folds)
A Phase 1/2 study testing Autologous Human Platelet Lysate in people with Facial Wrinkles (Nasolabial Folds), run by Kasiak Research Pvt. Ltd. at 1 site in India.
Trial summary
This is a multicentre, open label, pilot study to evaluate safety and efficacy of Autologous Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study is being conducted at 2 centers in India. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Facial Wrinkles (Nasolabial Folds)
- What is being tested?
- Autologous Human Platelet Lysate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Apr 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects (male and female), aged 18 to 40 years (both inclusive).
- Subjects willing to refrain from any other treatment for Nasolabial Folds.
- Subjects who are willing to give informed consent and adhere to the study protocol.
Who cannot join
- Subjects receiving any aesthetic facial therapy 6 months prior to enrolment e.g. Botox, Fillers etc
- Subjects with history of Connective tissue disease
- Subjects with autoimmune diseases
- Subjects unwilling to or unable to comply with the study protocol.
- Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicentric, Open Label, Bio-Interventional, Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment of Facial Wrinkles (Nasolabial Folds)
This is a multicentre, open label, pilot study to evaluate safety and efficacy of Autologous Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study is being conducted at 2 centers in India. The primary endpoints are Improvement in Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest and on full smile and Global Aesthetic Improvement Scale (GAIS). The secondary endpoints are improvement in photographic assessment, Physician's assessment scores, Patient's assessment scores form enrollment to end of study.
- Conditions
- Facial Wrinkles (Nasolabial Folds)
- Being tested
- Autologous Human Platelet Lysate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Human Platelet LysateOther
All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Other | All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region Receives: Other: Autologous Human Platelet Lysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile
Measured: Day 0, End of Study - 3 months
Secondary outcomes (1)
Global Aesthetic Improvement Scale
Measured: Day 0, End of study - Month 3
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 startApr 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 Facial Wrinkles (Nasolabial Folds)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasiak Research Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rachita Dhurat, Dr., Principal investigator, Dr Rachita's Skin, Trichology & Aesthetic CentreGeetanjali Shetty, Dr., Principal investigator, Kapadia Multispeciality Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644461
- Sponsor's protocol ID
- KRPL/HPL-FR/11-12/002B
- 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, Bio-Interventional, Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment of Facial Wrinkles (Nasolabial Folds)
- ClinicalTrials.gov ID
- NCT01644461
- Acronym / sponsor ID
- KRPL/HPL-FR/11-12/002B
- Conditions
- Facial Wrinkles (Nasolabial Folds)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kasiak Research Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 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, pilot study to evaluate safety and efficacy of Autologous Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study is being conducted at 2 centers in India. The primary endpoints are Improvement in Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest and on full smile and Global Aesthetic Improvement Scale (GAIS). The secondary endpoints are improvement in photographic assessment, Physician's assessment scores, Patient's assessment scores form enrollment to end of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Other | Other: Autologous Human Platelet LysateAll subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects (male and female), aged 18 to 40 years (both inclusive).
- Subjects willing to refrain from any other treatment for Nasolabial Folds.
- Subjects who are willing to give informed consent and adhere to the study protocol.
Key exclusion criteria (5 listed)
- Subjects receiving any aesthetic facial therapy 6 months prior to enrolment e.g. Botox, Fillers etc
- Subjects with history of Connective tissue disease
- Subjects with autoimmune diseases
- Subjects unwilling to or unable to comply with the study protocol.
- Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30days
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 LysateAll subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region | Other | Study Group |
Primary outcome
Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile
Time frame: Day 0, End of Study - 3 months
1 secondary outcome
Global Aesthetic Improvement Scale
Time frame: Day 0, End of study - Month 3
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.
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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.
Rachita Dhurat, Dr. principal investigator
Dr Rachita's Skin, Trichology & Aesthetic Centre
Geetanjali Shetty, Dr. principal investigator
Kapadia Multispeciality Hospital
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 in people with Facial Wrinkles (Nasolabial Folds), 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 5 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?
Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile (time frame: Day 0, End of Study - 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 25 Jul 2012.