Periorbital Hyperpigmentation (Dark Circles)Phase 1/2NCT01644448
A Study to Determine the Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Dark Circles
A Phase 1/2 study testing Autologous Human Platelet Lysate and Standard Therapy in people with Periorbital Hyperpigmentation (Dark Circles), run by Kasiak Research Pvt. Ltd. at 1 site in India.
Trial summary
This is a multicentre, open label, randomized, pilot study to evalute safety and efficacy of Human Platelet Lysate (HPL) in subjects with Periorbital Hyperpigmentation. The study is being conducted at 2 centers in India.The primary endpoints are Physicians and Patient Self assessment score. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Periorbital Hyperpigmentation (Dark Circles)
- What is being tested?
- Autologous Human Platelet Lysate and Standard Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Mar 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects (male and female), aged 18 to 55 years (both inclusive) with Periorbital Hyperpigmentation.
- Subject willing to refrain from any other treatment of Periorbital Hyperpigmentation during entire study duration.
- Subjects who are willing to give informed consent and adhere to the study protocol.
Who cannot join
- Subjects aged less than 18 and more than 55 years
- Subjects with history of connective tissue disease.
- Subjects with metabolic or hematopoietic disorders
- 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 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 (HPL) for Treatment of Periorbital Hyperpigmentation (Dark Circles)
This is a multicentre, open label, randomized, pilot study to evalute safety and efficacy of Human Platelet Lysate (HPL) in subjects with Periorbital Hyperpigmentation. The study is being conducted at 2 centers in India.The primary endpoints are Physicians and Patient Self assessment score. The secondary endpoints are improvement in photographic assessment form randomization to end of study.
- Being tested
- Autologous Human Platelet Lysate, Standard Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Human Platelet LysateOther
Subjects will receive one dose of 5 ml of HPL with simultaneous micro-needling on day 2
Standard TherapyOther
Topical Applications as directed by the investigator
| Study group | Role | What they receive |
|---|---|---|
| Study arm A | Other | Subjects will receive one dose of 5 ml of Autologous Human Platelet Lysate with simultaneous micro-needling on day 2 Receives: Other: Autologous Human Platelet Lysate |
| Control Arm B | Other | Topical Applications of the standard therapy as directed by the investigator Receives: Other: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographic Assessment
Measured: Day 0, Month 1, Month 2, End of Study - 3 months
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 startMar 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 Periorbital Hyperpigmentation (Dark Circles)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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Farida Modi, Dr., Principal investigator, DermacarePreeti Savardekar, Dr., Principal investigator, Shree Krishna PolyclinicSharmila Patil, Dr., Principal investigator, Dr. Sharmila's Dermocosmetic laser center, hair and skin clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644448
- Sponsor's protocol ID
- KRPL/HPL-FR/11-12/002A
- 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 (HPL) for Treatment of Periorbital Hyperpigmentation (Dark Circles)
- ClinicalTrials.gov ID
- NCT01644448
- Acronym / sponsor ID
- KRPL/HPL-FR/11-12/002A
- 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
- Mar 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 evalute safety and efficacy of Human Platelet Lysate (HPL) in subjects with Periorbital Hyperpigmentation. The study is being conducted at 2 centers in India.The primary endpoints are Physicians and Patient Self assessment score. The secondary endpoints are improvement in photographic assessment form randomization to end of study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm A | Other | Other: Autologous Human Platelet LysateSubjects will receive one dose of 5 ml of Autologous Human Platelet Lysate with simultaneous micro-needling on day 2 |
| Control Arm B | Other | Other: Standard TherapyTopical Applications of the standard therapy as directed by the investigator |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects (male and female), aged 18 to 55 years (both inclusive) with Periorbital Hyperpigmentation.
- Subject willing to refrain from any other treatment of Periorbital Hyperpigmentation during entire study duration.
- Subjects who are willing to give informed consent and adhere to the study protocol.
Key exclusion criteria (5 listed)
- Subjects aged less than 18 and more than 55 years
- Subjects with history of connective tissue disease.
- Subjects with metabolic or hematopoietic disorders
- 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 30 days.
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 LysateSubjects will receive one dose of 5 ml of HPL with simultaneous micro-needling on day 2 | Other | Study arm A |
| Standard TherapyTopical Applications as directed by the investigator | Other | Control Arm B |
Primary outcome
Photographic Assessment
Time frame: Day 0, Month 1, Month 2, End of Study - 3 months
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.
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.
Farida Modi, Dr. principal investigator
Dermacare
Preeti Savardekar, Dr. principal investigator
Shree Krishna Polyclinic
Sharmila Patil, Dr. principal investigator
Dr. Sharmila's Dermocosmetic laser center, hair and skin clinic
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 Therapy in people with Periorbital Hyperpigmentation (Dark Circles), 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?
Photographic Assessment (time frame: Day 0, Month 1, Month 2, 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.