Treatments of Striae GravidarumPhase 3NCT03328871
The Combination Therapy of Fractional Laser and PRP Compared With Nanofat Grafting and PRP Synergy in Treating Striae Gravidarum.
A Phase 3 study testing Fractional CO2 Laser, Nanofat grafting and Platelet-rich plasma (PRP) Injection in people with Treatments of Striae Gravidarum, run by First Affiliated Hospital of Jinan University at 1 site in China.
Trial summary
Nowadays, multiple treatment modalities have been applied clinically to treat striae gravidarum, such as laser therapy, microdermabrasion, platelet-rich plasma injection(PRP), etc. To some extent, these treatments can improve striae gravidarum. Read more about this study
- Who is it for?
- Ages Up to 35 years, women only
- Conditions the study is for
- Treatments of Striae Gravidarum
- What is being tested?
- Fractional CO2 Laser, Nanofat grafting and Platelet-rich plasma (PRP) Injection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 1 Nov 2018
- Phase
- Phase 3
- 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 Up to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- The striae gravidarum was appeared within 3 years
- Age ≤ 35 years old
- Not in lactation
- Not pregnancy within one year
Who cannot join
- Skin allergy
- Skin inflammation or wound
- Platelet dysfunction syndrome
- Take anticoagulant drugs
- Acute or chronic infection
- Chronic liver disease
Show all 9Show fewer
- Photodermatosis
- Active vitiligo, psoriasis, systemic lupus erythematosus
- Other clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 500011
About this study
Official title: The Combination Therapy of Fractional Laser and Platelet-Rich Plasma Injection Compared With Nanofat Grafting and Platelet-Rich Plasma Synergy in Treating Striae Gravidarum.
Nowadays, multiple treatment modalities have been applied clinically to treat striae gravidarum, such as laser therapy, microdermabrasion, platelet-rich plasma injection(PRP), etc. To some extent, these treatments can improve striae gravidarum. In this clinical trial, the investigators are going to treat striae gravidarum by using two different kinds of combination therapies. One is fractional laser and PRP injection synergy, and the other one is treated by nanofat grafting with PRP injection.
Read the detailed description
The investigators will pick out two areas of most severe striae gravidarum on a participant's abdomen. One of the areas will be treated by fractional laser once every three months for 2 times combined with PRP injection once a month for 6 times. Another area will be treated by nanofat grafting once every three months for 2 times and PRP therapy once a month for 6 times. The participants were asked to come back 1、3、6、9 months after treatment for further follow-up.
Before and after the treatment, the striae gravidarum will be assessed subjectively by satisfaction assessment, dermatoscope and ultrasound, and objectively by immunohistochemical analysis.
- Conditions
- Treatments of Striae Gravidarum
- Being tested
- Fractional CO2 Laser, Nanofat grafting, Platelet-rich plasma (PRP) Injection
- Keywords
- Striae Gravidarum, Fractional Laser, Platelet-Rich Plasma (PRP), Nanofat Graft, Combination Therapy
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO2 LaserDevice
Fractional Carbon Dioxide Laser will be treated once every three months for 2 times.
Nanofat graftingProcedure or surgery
Nanofat grafting will be applied once every three months for 2 times.
Platelet-rich plasma (PRP) InjectionProcedure or surgery
PRP Injection will be applied once a month for 6 times.
| Study group | Role | What they receive |
|---|---|---|
| Fractional CO2 Laser and PRP injection | Experimental | One of the striae gravidarum areas will be treated by fractional laser once every three months for 2 times combined with PRP injection once a month for 6 times. Receives: Device: Fractional CO2 Laser; Procedure: Platelet-rich plasma (PRP) Injection |
| Nanofat grafting and PRP injection | Experimental | Another area will be treated by nanofat grafting once every three months for 2 times and PRP therapy once a month for 6 times. Receives: Procedure: Nanofat grafting; Procedure: Platelet-rich plasma (PRP) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunohistochemical analysis
The tissue extracted will be taken for immunohistochemical analysis to observe the change of epidermal and dermal thickness, and the distribution and amount of elastic fiber and collagen fiber,etc.
Measured: Baseline and 15 months.
Secondary outcomes (2)
Dermatoscope
The striae gravidarum will be assessed by dermatoscope to observe the pigmentation condition of striae after the application of laser or nanofat grafting with PRP injection.
Measured: Baseline and at 3,6,9,12,15 months after the treatments.
Ultrasound
The striae gravidarum will be assessed by ultrasound in order to observe the change of dermal thickness of striae after the application of laser or nanofat grafting with PRP injection.
Measured: Baseline and at 3,6,9,12,15 months after the treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start1 Apr 2017
- Primary completion14 Dec 2017
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Treatments of Striae GravidarumStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Jinan University
- Sponsor type
- University, hospital or other
- Collaborators
- Science and Technology Program of Guangzhou
- Responsible party
- Principal investigator, Li-Ling Xiao, First Affiliated Hospital of Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328871
- Sponsor's protocol ID
- LXiao FirstJinanU
- Status last verified
- May 2018
- First submitted
- 26 Sep 2017
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cervelli V, Nicoli F, Spallone D, Verardi S, Sorge R, Nicoli M, Balzani A. Treatment of traumatic scars using fat grafts mixed with platelet-rich plasma, and resurfacing of skin with the 1540 nm nonablative laser. Clin Exp Dermatol. 2012 Jan;37(1):55-61. doi: 10.1111/j.1365-2230.2011.04199.x.
PubMed 22182435Kamakura T, Kataoka J, Maeda K, Teramachi H, Mihara H, Miyata K, Ooi K, Sasaki N, Kobayashi M, Ito K. Platelet-Rich Plasma with Basic Fibroblast Growth Factor for Treatment of Wrinkles and Depressed Areas of the Skin. Plast Reconstr Surg. 2015 Nov;136(5):931-939. doi: 10.1097/PRS.0000000000001705.
PubMed 26171752Mehryan P, Zartab H, Rajabi A, Pazhoohi N, Firooz A. Assessment of efficacy of platelet-rich plasma (PRP) on infraorbital dark circles and crow's feet wrinkles. J Cosmet Dermatol. 2014 Mar;13(1):72-8. doi: 10.1111/jocd.12072.
PubMed 24641609Kim IS, Park KY, Kim BJ, Kim MN, Kim CW, Kim SE. Efficacy of intradermal radiofrequency combined with autologous platelet-rich plasma in striae distensae: a pilot study. Int J Dermatol. 2012 Oct;51(10):1253-8. doi: 10.1111/j.1365-4632.2012.05530.x.
PubMed 22994672Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.
PubMed 23783059
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination Therapy of Fractional Laser and Platelet-Rich Plasma Injection Compared With Nanofat Grafting and Platelet-Rich Plasma Synergy in Treating Striae Gravidarum.
- ClinicalTrials.gov ID
- NCT03328871
- Acronym / sponsor ID
- LXiao FirstJinanU
- Conditions
- Treatments of Striae Gravidarum
- Keywords
- Striae Gravidarum, Fractional Laser, Platelet-Rich Plasma (PRP), Nanofat Graft, Combination Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Jinan UniversityUniversity, hospital or other
- Collaborators
- Science and Technology Program of Guangzhou
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 1 Nov 2017 (actual)
- 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.
Nowadays, multiple treatment modalities have been applied clinically to treat striae gravidarum, such as laser therapy, microdermabrasion, platelet-rich plasma injection(PRP), etc. To some extent, these treatments can improve striae gravidarum. In this clinical trial, the investigators are going to treat striae gravidarum by using two different kinds of combination therapies. One is fractional laser and PRP injection synergy, and the other one is treated by nanofat grafting with PRP injection.
Detailed description
The investigators will pick out two areas of most severe striae gravidarum on a participant's abdomen. One of the areas will be treated by fractional laser once every three months for 2 times combined with PRP injection once a month for 6 times. Another area will be treated by nanofat grafting once every three months for 2 times and PRP therapy once a month for 6 times. The participants were asked to come back 1、3、6、9 months after treatment for further follow-up.
Before and after the treatment, the striae gravidarum will be assessed subjectively by satisfaction assessment, dermatoscope and ultrasound, and objectively by immunohistochemical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional CO2 Laser and PRP injection | Experimental | Device: Fractional CO2 Laser, Procedure: Platelet-rich plasma (PRP) InjectionOne of the striae gravidarum areas will be treated by fractional laser once every three months for 2 times combined with PRP injection once a month for 6 times. |
| Nanofat grafting and PRP injection | Experimental | Procedure: Nanofat grafting, Procedure: Platelet-rich plasma (PRP) InjectionAnother area will be treated by nanofat grafting once every three months for 2 times and PRP therapy once a month for 6 times. |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- The striae gravidarum was appeared within 3 years
- Age ≤ 35 years old
- Not in lactation
- Not pregnancy within one year
Key exclusion criteria (9 listed)
- Skin allergy
- Skin inflammation or wound
- Platelet dysfunction syndrome
- Take anticoagulant drugs
- Acute or chronic infection
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 |
|---|---|---|
| Fractional CO2 LaserFractional Carbon Dioxide Laser will be treated once every three months for 2 times. | Device | Fractional CO2 Laser and PRP injection |
| Nanofat graftingNanofat grafting will be applied once every three months for 2 times. | Procedure or surgery | Nanofat grafting and PRP injection |
| Platelet-rich plasma (PRP) InjectionPRP Injection will be applied once a month for 6 times. | Procedure or surgery | Fractional CO2 Laser and PRP injection, Nanofat grafting and PRP injection |
Primary outcome
Immunohistochemical analysis
Time frame: Baseline and 15 months.
The tissue extracted will be taken for immunohistochemical analysis to observe the change of epidermal and dermal thickness, and the distribution and amount of elastic fiber and collagen fiber,etc.
2 secondary outcomes
Dermatoscope
Time frame: Baseline and at 3,6,9,12,15 months after the treatments.
Ultrasound
Time frame: Baseline and at 3,6,9,12,15 months after the treatments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Background: PubMed 22182435Cervelli V, Nicoli F, Spallone D, Verardi S, Sorge R, Nicoli M, Balzani A. Treatment of traumatic scars using fat grafts mixed with platelet-rich plasma, and resurfacing of skin with the 1540 nm nonablative laser. Clin Exp Dermatol. 2012 Jan;37(1):55-61. doi: 10.1111/j.1365-2230.2011.04199.x.
- Background: PubMed 26171752Kamakura T, Kataoka J, Maeda K, Teramachi H, Mihara H, Miyata K, Ooi K, Sasaki N, Kobayashi M, Ito K. Platelet-Rich Plasma with Basic Fibroblast Growth Factor for Treatment of Wrinkles and Depressed Areas of the Skin. Plast Reconstr Surg. 2015 Nov;136(5):931-939. doi: 10.1097/PRS.0000000000001705.
- Background: PubMed 24641609Mehryan P, Zartab H, Rajabi A, Pazhoohi N, Firooz A. Assessment of efficacy of platelet-rich plasma (PRP) on infraorbital dark circles and crow's feet wrinkles. J Cosmet Dermatol. 2014 Mar;13(1):72-8. doi: 10.1111/jocd.12072.
- Background: PubMed 22994672Kim IS, Park KY, Kim BJ, Kim MN, Kim CW, Kim SE. Efficacy of intradermal radiofrequency combined with autologous platelet-rich plasma in striae distensae: a pilot study. Int J Dermatol. 2012 Oct;51(10):1253-8. doi: 10.1111/j.1365-4632.2012.05530.x.
- Background: PubMed 23783059Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.
- Treatment of traumatic scars using fat grafts mixed with platelet-rich plasma, and resurfacing of skin with the 1540 nm nonablative laser.Link provided by the sponsor.
- Platelet-Rich Plasma with Basic Fibroblast Growth Factor for Treatment of Wrinkles and Depressed Areas of the Skin.Link provided by the sponsor.
- Assessment of efficacy of platelet-rich plasma (PRP) on infraorbital dark circles and crow's feet wrinkles.Link provided by the sponsor.
- Efficacy of intradermal radiofrequency combined with autologous platelet-rich plasma in striae distensae: a pilot study.Link provided by the sponsor.
- Nanofat grafting: basic research and clinical applications.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fractional CO2 Laser, Nanofat grafting and Platelet-rich plasma (PRP) Injection in people with Treatments of Striae Gravidarum, run by First Affiliated Hospital of Jinan University at 1 site in China.
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 9 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 May 2018. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Immunohistochemical analysis (time frame: Baseline and 15 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 NCT03328871, which also lists 5 linked publications.
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 May 2018.