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The Combination Therapy of Fractional Laser and PRP Compared With Nanofat Grafting and PRP Synergy in Treating Striae Gravidarum.

The Combination Therapy of Fractional Laser and Platelet-Rich Plasma Injection Compared With Nanofat Grafting and Platelet-Rich Plasma Synergy in Treating Striae Gravidarum.

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03328871
Enrollment
10
Registered
2017-11-01
Start date
2017-04-01
Completion date
2018-11-01
Last updated
2018-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatments of Striae Gravidarum

Keywords

Striae Gravidarum, Fractional Laser, Platelet-Rich Plasma (PRP), Nanofat Graft, Combination Therapy

Brief 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. 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.

Interventions

DEVICEFractional CO2 Laser

Fractional Carbon Dioxide Laser will be treated once every three months for 2 times.

Nanofat grafting will be applied once every three months for 2 times.

PRP Injection will be applied once a month for 6 times.

Sponsors

Science and Technology Program of Guangzhou
CollaboratorUNKNOWN
First Affiliated Hospital of Jinan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 35 Years
Healthy volunteers
No

Inclusion criteria

* The striae gravidarum was appeared within 3 years * Age ≤ 35 years old * Not in lactation * Not pregnancy within one year

Exclusion criteria

* Skin allergy * Skin inflammation or wound * Platelet dysfunction syndrome * Take anticoagulant drugs * Acute or chronic infection * Chronic liver disease * Photodermatosis * Active vitiligo, psoriasis, systemic lupus erythematosus * Other clinical trial

Design outcomes

Primary

MeasureTime frameDescription
Immunohistochemical analysisBaseline 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.

Secondary

MeasureTime frameDescription
DermatoscopeBaseline and at 3,6,9,12,15 months after the treatments.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.
UltrasoundBaseline and at 3,6,9,12,15 months after the treatments.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.

Other

MeasureTime frameDescription
Satisfaction assessmentsAfter every sessions of treatments, and at 6,9,12,15 months.The participants, investigators and physicians will fill in a satisfaction assessment about any complication during the treatments.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026