NCT03807986

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

3 months

First QC Date

January 2, 2019

Last Update Submit

January 16, 2019

Conditions

Treatments of Striae Distensae

Keywords

Striae DistensaePlatelet-Rich Plasma (PRP)Nanofat GraftMicrofat GraftCombination Therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline at 15 months.

Secondary Outcomes (2)

  • Ultrasound

    Change from baseline dermal thickness at 3,6,9,12,15 months of the treatments.

  • Ultrasound

    Change from baseline width of striae at 3,6,9,12,15 months of the treatments.

Other Outcomes (1)

  • Satisfaction assessments of participants: questionnaire

    At 15th month.

Study Arms (2)

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.

Procedure: Nanofat graftingProcedure: 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.

Procedure: Microfat graftingProcedure: Platelet-rich plasma (PRP) Injection

Interventions

Nanofat graftingPROCEDURE

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

Nanofat grafting and PRP injection
Microfat graftingPROCEDURE

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

Microfat grafting and PRP injection
Platelet-rich plasma (PRP) InjectionPROCEDURE

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

Microfat grafting and PRP injectionNanofat grafting and PRP injection

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The striae distensae
  • Age ≤ 35 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 500011, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 9747352BACKGROUND

  • Cho 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.

    PMID: 30345576BACKGROUND

  • Forbat 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.

    PMID: 29451986BACKGROUND

  • Hague 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.

    PMID: 28551068BACKGROUND

MeSH Terms

Conditions

Striae Distensae

Interventions

Injections

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Li Ling Xiao, MD

    First Affiliated Hospital of Jinan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pik Nga Cheung, MD

CONTACT

+8613631394662cheungpiknga@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief of Department of Plastic Surgery

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 17, 2019

Study Start

February 1, 2019

Primary Completion

May 1, 2019

Study Completion

December 31, 2020

Last Updated

January 17, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)