ACNE SCARRINGPhase 1/2NCT01644435
A Pilot Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Acne Scarring
A Phase 1/2 study testing Autologous Human Platelet Lysate in people with ACNE SCARRING, 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 Acne Scarring. 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
- ACNE SCARRING
- 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
- 19 participants
- Where
- 1 siteIndia
- Study dates
- May 2012to Oct 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).
- Subject willing to refrain from any other treatment of Acne Scarring during entire study duration.
- Non-pregnant, non-lactating females who agree to use adequate and acceptable methods of contraception from screening and throughout the course of the study.
- Subjects who are willing to give informed consent and adhere to the study protocol.
Who cannot join
- Subjects with active infection or active acne.
- Subjects receiving treatment: NSAIDs treatment within the last 7 days prior to the study.
- Subjects with history of connective tissue disease.
- Subjects with metabolic or hematopoietic disorders.
- Subjects with known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia.
- Subjects who have received prior chemotherapy and radiotherapy
- 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, Phase II Pilot Study to Evaluate the Safety and Efficacy of Autologous Human Platelet Lysate (HPL) for Treatment of Acne Scarring
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Acne Scarring. The study is being conducted at 2 centers in India. The primary endpoint is change in the Global Acne scarring classification scores from screening to end of the study. The secondary endpoints are Photographic Assessment, Physicians assessment score and Patients self assessment score.
- Conditions
- ACNE SCARRING
- 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 LysateBiological
Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring
Autologous Human Platelet LysateBiological
Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring
| Study group | Role | What they receive |
|---|---|---|
| Study arm A | Other | Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring Receives: Biological: Autologous Human Platelet Lysate |
| Study arm B | Other | Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring. Receives: Biological: Autologous Human Platelet Lysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Global Acne scarring classification
Measured: Day 0, End of study - Month 3
Secondary outcomes (1)
Photographic Assessment
Measured: Day 0, Month 1, Month 2 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 startMay 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACNE SCARRINGStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasiak Research Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharmila Patil, Dr., Principal investigator, Dermocosmetic laser center hair and skin clinicPankaj Maniar, Dr., Principal investigator, Radiance Cosmetology Clinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644435
- Sponsor's protocol ID
- KRPL/HPL-AS/11-12/004
- Status last verified
- Oct 2012
- First submitted
- 17 Jul 2012
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 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, Phase II Pilot Study to Evaluate the Safety and Efficacy of Autologous Human Platelet Lysate (HPL) for Treatment of Acne Scarring
- ClinicalTrials.gov ID
- NCT01644435
- Acronym / sponsor ID
- KRPL/HPL-AS/11-12/004
- Conditions
- ACNE SCARRING
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Kasiak Research Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- 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 Acne Scarring. The study is being conducted at 2 centers in India. The primary endpoint is change in the Global Acne scarring classification scores from screening to end of the study. The secondary endpoints are Photographic Assessment, Physicians assessment score and Patients self assessment score.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm A | Other | Biological: Autologous Human Platelet LysateSubjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring |
| Study arm B | Other | Biological: Autologous Human Platelet LysateSubjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects (male and female), aged 18 to 40 years (both inclusive).
- Subject willing to refrain from any other treatment of Acne Scarring during entire study duration.
- Non-pregnant, non-lactating females who agree to use adequate and acceptable methods of contraception from screening and throughout the course of the study.
- Subjects who are willing to give informed consent and adhere to the study protocol.
Key exclusion criteria (8 listed)
- Subjects with active infection or active acne.
- Subjects receiving treatment: NSAIDs treatment within the last 7 days prior to the study.
- Subjects with history of connective tissue disease.
- Subjects with metabolic or hematopoietic disorders.
- Subjects with known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia.
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 a single injection of Autologous Human Platelet Lysate for acne scarring | Biological | Study arm A |
| Autologous Human Platelet LysateSubjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring | Biological | Study arm B |
Primary outcome
Changes in the Global Acne scarring classification
Time frame: Day 0, End of study - Month 3
1 secondary outcome
Photographic Assessment
Time frame: Day 0, Month 1, Month 2 End of study - Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 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.
Sharmila Patil, Dr. principal investigator
Dermocosmetic laser center hair and skin clinic
Pankaj Maniar, Dr. principal investigator
Radiance Cosmetology Clinique
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 ACNE SCARRING, 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 4 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: finished, as of the sponsor's last update on 15 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in the Global Acne scarring classification (time frame: Day 0, End of study - Month 3). 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 15 Oct 2012.