## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** HangangSHH-13
#### Organization
**Class:** OTHER
**Full Name:** Hangang Sacred Heart Hospital
### Status Module
#### Completion Date
**Date:** 2022-04-20

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2021-08-13

**Type:** ACTUAL

**Last Update Submit Date:** 2021-08-09

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-08-10

**Type:** ESTIMATED

**Status Verified Date:** 2021-07

#### Study First Post Date
**Date:** 2021-08-13
**Type:** ACTUAL
**Study First Submit Date:** 2021-07-29
**Study First Submit QC Date:** 2021-08-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** National Research Foundation of Korea

#### Lead Sponsor

**Class:** OTHER

**Name:** Hangang Sacred Heart Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Stem Cell Media

- Hypertrophic Scar

- Regeneration

**Keywords:**

- stem cell media

- non ablative laser

- hypertrophic scar

- burns

- regeneration

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

**Intervention 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 Info

**Masking:** SINGLE

**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.

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** human media apply after non ablative laser treatment

**Intervention Names:**

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

**Label:** human stem cell media apply lesion

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** normal saline apply after non ablative laser treatment

**Intervention Names:**

- Procedure: normal saline was applied after non ablative laser therapy

**Label:** control condition lesion

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- human stem cell media apply lesion

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

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

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- control condition lesion

**Description:** physiological saline was applied to the other side.

**Name:** normal saline was applied after non ablative laser therapy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** The thickness was measured with a ultrasonic wave equipment

**Measure:** scar thickness (cm)

**Time Frame:** baseline

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

**Measure:** change from baseline scar thickness at 3 months (cm)

**Time Frame:** after 3 months intervention

#### Secondary Outcomes

**Description:** the higher values indicating a darker

**Measure:** melanin levels (arbitraty units; AU)

**Time Frame:** baseline

**Description:** the higher values indicating a darker

**Measure:** change from baseline melanin level at 3 months (arbitraty units; AU)

**Time Frame:** after 3 months intervention

**Description:** the higher values indicating a redder skin

**Measure:** erythema level (arbitraty units; AU)

**Time Frame:** baseline

**Description:** the higher values indicating a redder skin

**Measure:** change from baseline erythema level at 3 months (arbitraty units; AU)

**Time Frame:** after 3 months intervention

**Description:** the higher the number, the more dry the skin is.

**Measure:** transepidermal water loss (g/h/m2)

**Time Frame:** baseline

**Description:** the higher the number, the more dry the skin is.

**Measure:** change from baseline transepidermal water loss at 3 months (g/h/m2)

**Time Frame:** after 3 months intervention

**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.

**Measure:** Sebum level (μg sebum/cm2)

**Time Frame:** baseline

**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.

**Measure:** change from baseline sebum level at 3 months (μg sebum/cm2)

**Time Frame:** after 3 months intervention

### Eligibility Module

**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)

**Maximum Age:** 75 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** chseomd@gmail.com

**Name:** Cheong Hoon Seo, M.D.

**Phone:** +82 2 2639 5738

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 30403775

**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.

**PMID:** 23716460

**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.

**PMID:** 33632992

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002921

- Term: Cicatrix

- ID: D000005355

- Term: Fibrosis

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020763

- Term: Pathological Conditions, Anatomical

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M10035

- Name: Hypertrophy

- Relevance: HIGH

- As Found: Hypertrophic

- ID: M5326

- Name: Burns

- Relevance: LOW

- As Found: Unknown

- ID: M19708

- Name: Cicatrix, Hypertrophic

- Relevance: HIGH

- As Found: Hypertrophic Scar

- ID: M6160

- Name: Cicatrix

- Relevance: LOW

- As Found: Unknown

- ID: M8485

- Name: Fibrosis

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006984

- Term: Hypertrophy

- ID: D000017439

- Term: Cicatrix, Hypertrophic

### Misc Info Module

- Version Holder: 2024-05-24
