Treatments of Striae DistensaeNCT03807986
The Combination Therapy of Nanofat Grafting and PRP Compared With Microfat Grafting and PRP Synergy in Treating Striae Distensae
A study testing Nanofat grafting, Microfat grafting and Platelet-rich plasma (PRP) Injection in people with Treatments of Striae Distensae, run by First Affiliated Hospital of Jinan University at 1 site in China.
Trial summary
Striae distensae is caused by the fracture and damage of the elastic fibers and collagen fibers, which is still a difficulty to overcome. Based on the studies demonstrated that platelet-rich plasma(PRP) has positive effect on superficial scar, and nanofat and microfat are effective in treating atrophic scar. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Treatments of Striae Distensae
- What is being tested?
- Nanofat grafting, Microfat grafting and Platelet-rich plasma (PRP) Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 31 Dec 2020
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The striae distensae
- Age ≤ 35 years old
Who cannot join
- Skin allergy
- Cicatricial diathesis
- Skin inflammation or wound
- Platelet dysfunction syndrome
- Take anticoagulant drugs
- Acute or chronic infection
- Chronic liver disease
- Active vitiligo, psoriasis, systemic lupus erythematosus
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 500011
Pik Nga Cheung, MD, +8613631394662, cheungpiknga@126.com
About this study
Official title: The Combination Therapy of Nanofat Grafting and Platelet-Rich Plasma Injection Compared With Microfat Grafting and Platelet-Rich Plasma Injection Synergy in Treating Striae Distensae
Striae distensae is caused by the fracture and damage of the elastic fibers and collagen fibers, which is still a difficulty to overcome. Based on the studies demonstrated that platelet-rich plasma(PRP) has positive effect on superficial scar, and nanofat and microfat are effective in treating atrophic scar. So in this clinical trial, the investigators are going to treat striae distensae by using two combination therapies. One is nanofat grafting and PRP injection synergy, and the other one is treated by microfat grafting with PRP injection.
Read the detailed description
The participants were randomly assigned into two groups. Group A is treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times. Group B will be treated by microfat grafting onceevery three months for 2 times combined with PRP injection 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 distensae will be assessed subjectively by satisfaction assessment, and objectively by ultrasound and immunohistochemical analysis.
- Conditions
- Treatments of Striae Distensae
- Being tested
- Nanofat grafting, Microfat grafting, Platelet-rich plasma (PRP) Injection
- Keywords
- Striae Distensae, Platelet-Rich Plasma (PRP), Nanofat Graft, Microfat 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.
Nanofat graftingProcedure or surgery
Nanofat grafting will be applied once every three months for 2 times.
Microfat graftingProcedure or surgery
Microfat 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 |
|---|---|---|
| Nanofat grafting and PRP injection | Experimental | Striae diatensae will be treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times. Receives: Procedure: Nanofat grafting; Procedure: Platelet-rich plasma (PRP) Injection |
| Microfat grafting and PRP injection | Experimental | Striae diatensae will be treated by microfat grafting once every three months for 2 times combined with PRP injection once a month for 6 times. Receives: Procedure: Microfat 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 amount of elastic fiber and collagen fiber,etc. More collagen fiber generated better outcome of the treatments.
Measured: Change from baseline at 15 months.
Secondary outcomes (2)
Ultrasound
The striae distensae will be assessed by ultrasound in order to observe the change of dermal thickness of striae after the application of nanofat or microfat grafting with PRP injection. if the treatments worked, the dermal thickness will be increased.
Measured: Change from baseline dermal thickness at 3,6,9,12,15 months of the treatments.
Ultrasound
The striae distensae will be assessed by ultrasound in order to observe the change of width of striae after the application of nanofat or microfat grafting with PRP injection. Smaller the width better the results.
Measured: Change from baseline width of striae at 3,6,9,12,15 months of the treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start1 Feb 2019 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Treatments of Striae DistensaeStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 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,Guangzhou Sipintang Biological technology Co., Ltd.
- Responsible party
- Principal investigator, Li-Ling Xiao, First Affiliated Hospital of Jinan University
- Investigators
- Li Ling Xiao, MD, Principal investigator, First Affiliated Hospital of Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807986
- Sponsor's protocol ID
- Xiao FirstJinanU
- Status last verified
- Jan 2019
- First submitted
- 2 Jan 2019
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Watson RE, Parry EJ, Humphries JD, Jones CJ, Polson DW, Kielty CM, Griffiths CE. Fibrillin microfibrils are reduced in skin exhibiting striae distensae. Br J Dermatol. 1998 Jun;138(6):931-7. doi: 10.1046/j.1365-2133.1998.02257.x.
PubMed 9747352Cho C, Cho E, Kim N, Shin J, Woo S, Lee J, Lee J, Lee E, Ha J. Biophysical properties of striae rubra and striae alba in human skin: Comparison with normal skin. Skin Res Technol. 2019 May;25(3):283-288. doi: 10.1111/srt.12645. Epub 2018 Oct 22.
PubMed 30345576Forbat E, Al-Niaimi F. Treatment of striae distensae: An evidence-based approach. J Cosmet Laser Ther. 2019;21(1):49-57. doi: 10.1080/14764172.2017.1418515. Epub 2018 Feb 16.
PubMed 29451986Hague A, Bayat A. Therapeutic targets in the management of striae distensae: A systematic review. J Am Acad Dermatol. 2017 Sep;77(3):559-568.e18. doi: 10.1016/j.jaad.2017.02.048. Epub 2017 May 24.
PubMed 28551068
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination Therapy of Nanofat Grafting and Platelet-Rich Plasma Injection Compared With Microfat Grafting and Platelet-Rich Plasma Injection Synergy in Treating Striae Distensae
- ClinicalTrials.gov ID
- NCT03807986
- Acronym / sponsor ID
- Xiao FirstJinanU
- Conditions
- Treatments of Striae Distensae
- Keywords
- Striae Distensae, Platelet-Rich Plasma (PRP), Nanofat Graft, Microfat Graft, Combination Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Jinan UniversityUniversity, hospital or other
- Collaborators
- Science and Technology Program of Guangzhou,Guangzhou Sipintang Biological technology Co., Ltd.
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 17 Jan 2019 (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.
Striae distensae is caused by the fracture and damage of the elastic fibers and collagen fibers, which is still a difficulty to overcome. Based on the studies demonstrated that platelet-rich plasma(PRP) has positive effect on superficial scar, and nanofat and microfat are effective in treating atrophic scar. So in this clinical trial, the investigators are going to treat striae distensae by using two combination therapies. One is nanofat grafting and PRP injection synergy, and the other one is treated by microfat grafting with PRP injection.
Detailed description
The participants were randomly assigned into two groups. Group A is treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times. Group B will be treated by microfat grafting onceevery three months for 2 times combined with PRP injection 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 distensae will be assessed subjectively by satisfaction assessment, and objectively by ultrasound and 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 |
|---|---|---|
| Nanofat grafting and PRP injection | Experimental | Procedure: Nanofat grafting, Procedure: Platelet-rich plasma (PRP) InjectionStriae diatensae will be treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times. |
| Microfat grafting and PRP injection | Experimental | Procedure: Microfat grafting, Procedure: Platelet-rich plasma (PRP) InjectionStriae diatensae will be treated by microfat grafting once every three months for 2 times combined with PRP injection once a month for 6 times. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The striae distensae
- Age ≤ 35 years old
Key exclusion criteria (8 listed)
- Skin allergy
- Cicatricial diathesis
- Skin inflammation or wound
- Platelet dysfunction syndrome
- Take anticoagulant drugs
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 |
|---|---|---|
| Nanofat graftingNanofat grafting will be applied once every three months for 2 times. | Procedure or surgery | Nanofat grafting and PRP injection |
| Microfat graftingMicrofat grafting will be applied once every three months for 2 times. | Procedure or surgery | Microfat grafting and PRP injection |
| Platelet-rich plasma (PRP) InjectionPRP Injection will be applied once a month for 6 times. | Procedure or surgery | Microfat grafting and PRP injection, Nanofat grafting and PRP injection |
Primary outcome
Immunohistochemical analysis
Time frame: Change from baseline at 15 months.
The tissue extracted will be taken for immunohistochemical analysis to observe the amount of elastic fiber and collagen fiber,etc. More collagen fiber generated better outcome of the treatments.
2 secondary outcomes
Ultrasound
Time frame: Change from baseline dermal thickness at 3,6,9,12,15 months of the treatments.
Ultrasound
Time frame: Change from baseline width of striae at 3,6,9,12,15 months of the treatments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Background: PubMed 9747352Watson RE, Parry EJ, Humphries JD, Jones CJ, Polson DW, Kielty CM, Griffiths CE. Fibrillin microfibrils are reduced in skin exhibiting striae distensae. Br J Dermatol. 1998 Jun;138(6):931-7. doi: 10.1046/j.1365-2133.1998.02257.x.
- Background: PubMed 30345576Cho C, Cho E, Kim N, Shin J, Woo S, Lee J, Lee J, Lee E, Ha J. Biophysical properties of striae rubra and striae alba in human skin: Comparison with normal skin. Skin Res Technol. 2019 May;25(3):283-288. doi: 10.1111/srt.12645. Epub 2018 Oct 22.
- Background: PubMed 29451986Forbat E, Al-Niaimi F. Treatment of striae distensae: An evidence-based approach. J Cosmet Laser Ther. 2019;21(1):49-57. doi: 10.1080/14764172.2017.1418515. Epub 2018 Feb 16.
- Background: PubMed 28551068Hague A, Bayat A. Therapeutic targets in the management of striae distensae: A systematic review. J Am Acad Dermatol. 2017 Sep;77(3):559-568.e18. doi: 10.1016/j.jaad.2017.02.048. Epub 2017 May 24.
- Individual participant dataSharing planned: No
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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.
Li Ling Xiao, MD principal investigator
First Affiliated Hospital of Jinan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanofat grafting, Microfat grafting and Platelet-rich plasma (PRP) Injection in people with Treatments of Striae Distensae, 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 2 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: status not confirmed, as of the sponsor's last update on 17 Jan 2019. 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.
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?
Contact Pik Nga Cheung, MD (+8613631394662, cheungpiknga@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunohistochemical analysis (time frame: Change from baseline at 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 NCT03807986, which also lists 4 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 17 Jan 2019.