Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar
Primary Purpose
Stem Cell Media, Hypertrophic Scar, Regeneration
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
human stem cell conditioned media was applied after non-ablative laser therapy
normal saline was applied after non ablative laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stem Cell Media focused on measuring stem cell media, non ablative laser, hypertrophic scar, burns, regeneration
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
human stem cell media apply lesion
control condition lesion
Arm Description
human media apply after non ablative laser treatment
normal saline apply after non ablative laser treatment
Outcomes
Primary Outcome Measures
scar thickness (cm)
The thickness was measured with a ultrasonic wave equipment
change from baseline scar thickness at 3 months (cm)
the change of scar thickness was measured with a ultrasonic wave equipment
Secondary Outcome Measures
melanin levels (arbitraty units; AU)
the higher values indicating a darker
change from baseline melanin level at 3 months (arbitraty units; AU)
the higher values indicating a darker
erythema level (arbitraty units; AU)
the higher values indicating a redder skin
change from baseline erythema level at 3 months (arbitraty units; AU)
the higher values indicating a redder skin
transepidermal water loss (g/h/m2)
the higher the number, the more dry the skin is.
change from baseline transepidermal water loss at 3 months (g/h/m2)
the higher the number, the more dry the skin is.
Sebum level (μg sebum/cm2)
A microprocessor calculates the result, which is shown on the display in μg/cm2. The higher the number, the more oily the skin is.
change from baseline sebum level at 3 months (μg sebum/cm2)
A microprocessor calculates the result, which is shown on the display in μg/cm2. The higher the number, the more oily the skin is.
Full Information
NCT ID
NCT05004779
First Posted
July 29, 2021
Last Updated
August 9, 2021
Sponsor
Hangang Sacred Heart Hospital
Collaborators
National Research Foundation of Korea
1. Study Identification
Unique Protocol Identification Number
NCT05004779
Brief Title
Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar
Official Title
Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar Caused by Burns
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
April 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangang Sacred Heart Hospital
Collaborators
National Research Foundation of Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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. Nonablative laser treatment was performed on 30 patients with hypertrophic scars on both sides of the same part of the body. Immediately after the laser treatment, the hypertrophic scars of right side to which HSCM was applied and the left side with the same body position were defined as a control scar, and normal saline was applied. Over the next 6 days, HSCM and moisturizer were applied on the scars of right side, and only moisturizer was applied on the control scar of left side. Laser treatment was performed three times on the hypertrophic scar at 4 weeks intervals. The skin test on hypertrophic scar was evaluated before laser treatment and re-evaluated on the 7the day after the 3rd laser treatment. The thickness was measured with a ultrasonic wave equipment (128 BW1 Medison, Korea). Mexameter® (MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin. Transepidermal water loss (TEWL) was measured with a Tewameter® (Courage-Khazaka Electronic GmbH, Germany), which is used for evaluating water evaporation. Sebum in the scars was measured with the Sebumeter® (Courage-Khazaka Electronic GmbH, Germany). The measurement is based on the principle of grease-spot photometry using a cassette with its special tape. A microprocessor calculates the result, which is shown on the display in μg/cm2. Elasticity was measured using Cutometer SEM 580® (Courage-Khazaka Electronic GmbH, Cologne, Germany), which applies negative pressure (450 mbar) on the skin. The numeric values (mm) of the skin's distortion is presented as the elasticity (Table 1). Two seconds of negative pressure of 450 mbar is followed by 2 s of recess, and this consists of a complete cycle. Three measurement cycles were conducted, and the average values were obtained. To evaluate the effect of HSCM, investigators compared the skin test results (thickness, melanin, erythema, TEWL, sebum, and skin elasticity levels) between the right side and control side, from baseline measures immediately before the laser treatment and measures on the 7the day after the 3rd laser treatment. Outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention. Possible complications (pain, ecchymosis, skin abrasion, and swelling) were observed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stem Cell Media, Hypertrophic Scar, Regeneration
Keywords
stem cell media, non ablative laser, hypertrophic scar, burns, regeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
Participant
Masking Description
After laser treatment on hypertrophic scars, human stem cell media was applied to one side and physiological saline was applied to the other side.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
human stem cell media apply lesion
Arm Type
Experimental
Arm Description
human media apply after non ablative laser treatment
Arm Title
control condition lesion
Arm Type
Sham Comparator
Arm Description
normal saline apply after non ablative laser treatment
Intervention Type
Procedure
Intervention Name(s)
human stem cell conditioned media was applied after non-ablative laser therapy
Intervention Description
After laser treatment on hypertrophic scars, human stem cell media was applied to one side
Intervention Type
Procedure
Intervention Name(s)
normal saline was applied after non ablative laser therapy
Intervention Description
physiological saline was applied to the other side.
Primary Outcome Measure Information:
Title
scar thickness (cm)
Description
The thickness was measured with a ultrasonic wave equipment
Time Frame
baseline
Title
change from baseline scar thickness at 3 months (cm)
Description
the change of scar thickness was measured with a ultrasonic wave equipment
Time Frame
after 3 months intervention
Secondary Outcome Measure Information:
Title
melanin levels (arbitraty units; AU)
Description
the higher values indicating a darker
Time Frame
baseline
Title
change from baseline melanin level at 3 months (arbitraty units; AU)
Description
the higher values indicating a darker
Time Frame
after 3 months intervention
Title
erythema level (arbitraty units; AU)
Description
the higher values indicating a redder skin
Time Frame
baseline
Title
change from baseline erythema level at 3 months (arbitraty units; AU)
Description
the higher values indicating a redder skin
Time Frame
after 3 months intervention
Title
transepidermal water loss (g/h/m2)
Description
the higher the number, the more dry the skin is.
Time Frame
baseline
Title
change from baseline transepidermal water loss at 3 months (g/h/m2)
Description
the higher the number, the more dry the skin is.
Time Frame
after 3 months intervention
Title
Sebum level (μg sebum/cm2)
Description
A microprocessor calculates the result, which is shown on the display in μg/cm2. The higher the number, the more oily the skin is.
Time Frame
baseline
Title
change from baseline sebum level at 3 months (μg sebum/cm2)
Description
A microprocessor calculates the result, which is shown on the display in μg/cm2. The higher the number, the more oily the skin is.
Time Frame
after 3 months intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheong Hoon Seo, M.D.
Phone
+82 2 2639 5738
Email
chseomd@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30403775
Citation
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.
Results Reference
background
PubMed Identifier
23716460
Citation
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.
Results Reference
result
PubMed Identifier
33632992
Citation
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.
Results Reference
result
Learn more about this trial
Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar
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