Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar

Hypertrophic Scar Clinical Trial

Official title:

Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar Caused by Burns

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05004779
• Other study ID #: HangangSHH-13
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 10, 2021
• Est. completion date: April 20, 2022

Study information

• Verified date: July 2021
• Source: Hangang Sacred Heart Hospital
• Contact: Cheong Hoon Seo, M.D.
• Phone: +82 2 2639 5738
• Email: chseomd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 20, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Hypertrophy
• Regeneration

Intervention

Procedure:
• human stem cell conditioned media was applied after non-ablative laser therapy
After laser treatment on hypertrophic scars, human stem cell media was applied to one side
• normal saline was applied after non ablative laser therapy
physiological saline was applied to the other side.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hangang Sacred Heart Hospital	National Research Foundation of Korea

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scar thickness (cm)	The thickness was measured with a ultrasonic wave equipment	baseline
Primary	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	melanin levels (arbitraty units; AU)	the higher values indicating a darker	baseline
Secondary	change from baseline melanin level at 3 months (arbitraty units; AU)	the higher values indicating a darker	after 3 months intervention
Secondary	erythema level (arbitraty units; AU)	the higher values indicating a redder skin	baseline
Secondary	change from baseline erythema level at 3 months (arbitraty units; AU)	the higher values indicating a redder skin	after 3 months intervention
Secondary	transepidermal water loss (g/h/m2)	the higher the number, the more dry the skin is.	baseline
Secondary	change from baseline transepidermal water loss at 3 months (g/h/m2)	the higher the number, the more dry the skin is.	after 3 months intervention
Secondary	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.	baseline
Secondary	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.	after 3 months intervention