Skin WrinklingNCT02832583
Autologous Platelet Rich Plasma Combined to Hyaluronic Acid Obtained With Regen-Kit BCT-HA in Aesthetic Medicine
A study testing Regenkit BCT-HA Cellular Matrix in people with Skin Wrinkling, run by Regen Lab SA.
Trial summary
The aim of this prospective study is to assess the efficacy of autologous Platelet Rich Plasma combined with Hyaluronic Acid prepared with RegenKit-BCT HA Cellular Matrix on skin rejuvenation. Thirty-one patients were included and received three PRP-AH injection sessions 4 weeks apart into the cheeks. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Skin Wrinkling
- What is being tested?
- Regenkit BCT-HA Cellular Matrix
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Jun 2016
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 40 years with chronological aging
- Completed informed consent form
Who cannot join
- Pregnancy or breastfeeding
- Patients younger than 40 years
- Use of product or treatment aimed to improve skin rejuvenation over the last six months before study start,
- patients with known hypersensitivity to HA,
- patients with eczema flare-up,
- patients with active skin disorder infection including herpes virus infection, active hepatitis or human infection virus infection.
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- Dermatological diseases affecting the face
- Auto-immune disease such as Hashimoto, rheumatoid arthritis.
- Malignancy with or without metastatic disease
- Chemotherapy
- Anticoagulant therapy
About this study
Official title: Efficacy of the Use of Autologous Platelet Rich Plasma Combined to Hyaluronic Acid Obtained With regenKit BCT-HA Cellular Matrix for Skin in Aesthetic Medicine
The aim of this prospective study is to assess the efficacy of autologous Platelet Rich Plasma combined with Hyaluronic Acid prepared with RegenKit-BCT HA Cellular Matrix on skin rejuvenation. Thirty-one patients were included and received three PRP-AH injection sessions 4 weeks apart into the cheeks. The outcomes were assessed at baseline, 1, 3 and 6 months after the last injection session. Safety was assessed by reported adverse event analysis.
- Conditions
- Skin Wrinkling
- Being tested
- Regenkit BCT-HA Cellular Matrix
- Keywords
- PRP, hyaluronic acid, mesotherapy, skin wrinkle, skin rejuvenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenkit BCT-HA Cellular MatrixDevice
To assess the efficacy of PRP-HA on skin rejuvenation, thirty one patients with chronological aging including wrinkles, dull and dry skin with loss of elasticity and firmness. The patients received three PRP-AH injection sessions 4 weeks apart into the cheeks.
| Study group | Role | What they receive |
|---|---|---|
| Mesotherapy of PRP-HA into the cheeks | Experimental | Three sessions of PRP-HA prepared with RegenKit BCT-HA Cellular Matrix into each cheek separated by 1 month interval. Receives: Device: Regenkit BCT-HA Cellular Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the changes of facial apparent overall assessed by FACE-Q scale.
Evaluate changes in facial apparent assessed by FACE-Q scale after 6 month of Autologous Platelet Rich Plasma combined to hyaluronic acid compared to baseline (before treatment)
Measured: 6 months
Secondary outcomes (1)
Evaluate the changes of skin elasticity assessed by the Cutometer®
Evaluate changes in skin elasticity assessed by the Cutometer® after 6 months of Autologous Platelet Rich Plasma combined to hyaluronic acid compared to baseline (before treatment).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin WrinklingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regen Lab SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832583
- Sponsor's protocol ID
- 2014-A00718-39
- Status last verified
- Sep 2016
- First submitted
- 5 Jul 2016
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Hersant B, SidAhmed-Mezi M, Niddam J, La Padula S, Noel W, Ezzedine K, Rodriguez AM, Meningaud JP. Efficacy of autologous platelet-rich plasma combined with hyaluronic acid on skin facial rejuvenation: A prospective study. J Am Acad Dermatol. 2017 Sep;77(3):584-586. doi: 10.1016/j.jaad.2017.05.022. No abstract available.
PubMed 28807118
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Use of Autologous Platelet Rich Plasma Combined to Hyaluronic Acid Obtained With regenKit BCT-HA Cellular Matrix for Skin in Aesthetic Medicine
- ClinicalTrials.gov ID
- NCT02832583
- Acronym / sponsor ID
- 2014-A00718-39
- Conditions
- Skin Wrinkling
- Keywords
- PRP, hyaluronic acid, mesotherapy, skin wrinkle, skin rejuvenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Regen Lab SAIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 14 Jul 2016 (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.
The aim of this prospective study is to assess the efficacy of autologous Platelet Rich Plasma combined with Hyaluronic Acid prepared with RegenKit-BCT HA Cellular Matrix on skin rejuvenation. Thirty-one patients were included and received three PRP-AH injection sessions 4 weeks apart into the cheeks. The outcomes were assessed at baseline, 1, 3 and 6 months after the last injection session. Safety was assessed by reported adverse event analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesotherapy of PRP-HA into the cheeks | Experimental | Device: Regenkit BCT-HA Cellular MatrixThree sessions of PRP-HA prepared with RegenKit BCT-HA Cellular Matrix into each cheek separated by 1 month interval. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged over 40 years with chronological aging
- Completed informed consent form
Key exclusion criteria (11 listed)
- Pregnancy or breastfeeding
- Patients younger than 40 years
- Use of product or treatment aimed to improve skin rejuvenation over the last six months before study start,
- patients with known hypersensitivity to HA,
- patients with eczema flare-up,
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 |
|---|---|---|
| Regenkit BCT-HA Cellular MatrixTo assess the efficacy of PRP-HA on skin rejuvenation, thirty one patients with chronological aging including wrinkles, dull and dry skin with loss of elasticity and firmness. The patients received three PRP-AH injection sessions 4 weeks apart into the cheeks. | Device | Mesotherapy of PRP-HA into the cheeks |
Primary outcome
Evaluate the changes of facial apparent overall assessed by FACE-Q scale.
Time frame: 6 months
Evaluate changes in facial apparent assessed by FACE-Q scale after 6 month of Autologous Platelet Rich Plasma combined to hyaluronic acid compared to baseline (before treatment)
1 secondary outcome
Evaluate the changes of skin elasticity assessed by the Cutometer®
Time frame: 6 months
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 3 Oct 2016.
- Derived from this study: PubMed 28807118Hersant B, SidAhmed-Mezi M, Niddam J, La Padula S, Noel W, Ezzedine K, Rodriguez AM, Meningaud JP. Efficacy of autologous platelet-rich plasma combined with hyaluronic acid on skin facial rejuvenation: A prospective study. J Am Acad Dermatol. 2017 Sep;77(3):584-586. doi: 10.1016/j.jaad.2017.05.022. No abstract available.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Regenkit BCT-HA Cellular Matrix in people with Skin Wrinkling, run by Regen Lab SA.
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 11 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 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Evaluate the changes of facial apparent overall assessed by FACE-Q scale. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02832583, which also lists 1 linked publication.
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 3 Oct 2016.