NCT05004779

Brief Summary

The purpose of this study was to determine the effect of combined treatment using nonablative laser and human stem cell media (HSCM) on the regeneration of hypertrophic scars that occurred after burns.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

August 10, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2022

Completed
Last Updated

August 13, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

July 29, 2021

Last Update Submit

August 9, 2021

Conditions

Stem Cell MediaHypertrophic ScarRegeneration

Keywords

stem cell medianon ablative laserhypertrophic scarburnsregeneration

Outcome Measures

Primary Outcomes (2)

  • scar thickness (cm)

    The thickness was measured with a ultrasonic wave equipment

    baseline

  • change from baseline scar thickness at 3 months (cm)

    the change of scar thickness was measured with a ultrasonic wave equipment

    after 3 months intervention

Secondary Outcomes (8)

  • melanin levels (arbitraty units; AU)

    baseline

  • change from baseline melanin level at 3 months (arbitraty units; AU)

    after 3 months intervention

  • erythema level (arbitraty units; AU)

    baseline

  • change from baseline erythema level at 3 months (arbitraty units; AU)

    after 3 months intervention

  • transepidermal water loss (g/h/m2)

    baseline

  • +3 more secondary outcomes

Study Arms (2)

human stem cell media apply lesion

EXPERIMENTAL

human media apply after non ablative laser treatment

Procedure: human stem cell conditioned media was applied after non-ablative laser therapy

control condition lesion

SHAM COMPARATOR

normal saline apply after non ablative laser treatment

Procedure: normal saline was applied after non ablative laser therapy

Interventions

human stem cell conditioned media was applied after non-ablative laser therapyPROCEDURE

After laser treatment on hypertrophic scars, human stem cell media was applied to one side

human stem cell media apply lesion
normal saline was applied after non ablative laser therapyPROCEDURE

physiological saline was applied to the other side.

control condition lesion

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • partial or full-thickness burns that healed spontaneously or required skin grafting
  • with hypertrophic scars on the right and left sides of the same body part

You may not qualify if:

  • Patients with open wounds or infection on the burn scars
  • those taking steroids for the scars
  • with allergies to topical anesthetic cream
  • those who were pregnant
  • undergoing any other medical treatment or condition affecting wound healing (e.g., diabetes)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Onur Erol O, Agaoglu G, Jawad MA. Combined Non-Ablative Laser and Microfat Grafting for Burn Scar Treatment. Aesthet Surg J. 2019 Mar 14;39(4):NP55-NP67. doi: 10.1093/asj/sjy291.

    PMID: 30403775BACKGROUND

  • Jayaraman P, Nathan P, Vasanthan P, Musa S, Govindasamy V. Stem cells conditioned medium: a new approach to skin wound healing management. Cell Biol Int. 2013 Oct;37(10):1122-8. doi: 10.1002/cbin.10138. Epub 2013 Jun 24.

    PMID: 23716460RESULT

  • Park IS. Enhancement of Wound Healing by Conditioned Medium of Adipose-Derived Stromal Cell with Photobiomodulation in Skin Wound. Int J Stem Cells. 2021 May 30;14(2):212-220. doi: 10.15283/ijsc20175.

    PMID: 33632992RESULT

MeSH Terms

Conditions

Cicatrix, HypertrophicBurns

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Central Study Contacts

Cheong Hoon Seo, M.D.

CONTACT

+82 2 2639 5738chseomd@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
After laser treatment on hypertrophic scars, human stem cell media was applied to one side and physiological saline was applied to the other side.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: After laser treatment on hypertrophic scars, human stem cell conditioned media was applied to one side and physiological saline was applied to the other side.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 13, 2021

Study Start

August 10, 2021

Primary Completion

December 31, 2021

Study Completion

April 20, 2022

Last Updated

August 13, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share