Microneedle Versus Fractional CO₂ Laser for Skin Aging Treatment With Stem Cell Secretome in Indonesian Adult Women

NCT05508191 | Completed

• 1 other identifier: 22-08-0682
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Evidences regarding the effectiveness of adipose-derived mesenchymal stem cells (ADMSCs) secretome to alleviate skin aging have been extensively available, yet no studies hitherto directly investigated the best administration technique for such purpose. The objective of this study is to compare microneedling and fractional CO₂ laser methods in administrating ADMSCs secretome for facial skin rejuvenation of Indonesian adult women.

Conditions

Skin Aging; Transepidermal Water Loss

Keywords

Adipose-derived mesenchymal stem cells; Fractional CO₂ laser; Microneedling; Secretome; Skin rejuvenation

Outcome Measures

Primary Outcomes (4)

• Skin aging changes evaluated by dermoscopy photoaging scale (DPAS)

  A thorough evaluation using dermoscope upon 11 parameters of skin aging (yellowish papules, solar elastosis, skin atrophy, lentigo, hypopigmented and hyperpigmented macules, telangiectasia, actinic keratosis, senile comedones, superficial wrinkles, deep wrinkles, and criss-cross wrinkles) observed on 4 locations (forehead, periorbita, zygoma, and mandible). Each finding on each location has a value of 1, so the maximum possible total score is 44. \*This is a numeric variable.

  Week 0 (baseline), week 2 before intervention, week 4 before intervention, week 6 (end of trial)

• Skin aging changes evaluated by Janus-3Ⓡ skin analyzer

  A comprehensive evaluation using Janus-3Ⓡ skin analyzer upon 4 parameters of skin aging (wrinkle, pore size, pigmentation, and sebum) observed on the same location for each assessment. Each finding is expressed as percentage (%). \*This is a numeric variable.

  Week 0 (baseline), week 2 before intervention, week 4 before intervention, week 6 (end of trial)

• Skin capacitance evaluated by the CorneometerⓇ

  Total water content in the stratum corneum of the skin, reported in microsiemens. \*This is a numeric variable.

  Week 0 (baseline), week 2 before intervention, week 4 before intervention, week 6 (end of trial)

• Transepidermal water loss evaluated by the TewameterⓇ

  Water evaporation rate in a given area of skin, reported in gram/m²/hour. \*This is a numeric variable.

  Week 0 (baseline), week 2 before intervention, week 4 before intervention, week 6 (end of trial)

Secondary Outcomes (4)

• Likert scale for the satisfaction degree

  Week 6 (end of trial)

• Visual analog scale (VAS) of pain for the convenience degree

  Week 6 (end of trial)

• Number of adverse events experienced during the clinical trial

  Week 2 thirty minutes after intervention, week 4 thirty minutes after intervention, week 6 (end of trial)

• Subjective preference to treatment

  Week 6 (end of trial)

Study Arms (2)

Secretome + Fractional CO₂ Laser

EXPERIMENTAL

This clinical study uses a 4-fold concentrate of ADMSCs secretome developed by PT. Kimia Farma (Persero), Tbk. The secretome is extracted from stem cell line filtered through syringe with pore size of 0.22 µm to eliminate the debris, then concentrated with CorningⓇ Spin-XⓇ UF 500 µL centrifugator. Stabilization analysis is performed before utilization. As for fractional CO₂ laser, AMIⓇ device is used with this following settings: 15 mJ energy, 900 µs pulse duration, density level 15, and depth level 2.

Device: Fractional CO₂ Laser

Secretome + Microneedle

EXPERIMENTAL

This clinical study uses a 4-fold concentrate of ADMSCs secretome developed by PT. Kimia Farma (Persero), Tbk. The secretome is extracted from stem cell line filtered through syringe with pore size of 0.22 µm to eliminate the debris, then concentrated with CorningⓇ Spin-XⓇ UF 500 µL centrifugator. Stabilization analysis is performed before utilization. As for microneedle, DrPenⓇ dermapen is used in this following direction and order: vertical, horizontal, and diagonal, with the depth of 150 µm.

Device: Microneedle

Interventions

Fractional CO₂ Laser DEVICE

Prior to the treatment, each participant will be evaluated for their initial skin status, followed by daily priming with 0.05% retinoic acid cream, applied topically at night for two weeks. At second week, the participants will undergo facial skin anesthesia utilizing 2.5% lidocaine+2.5% prilocaine cream for 30 minutes. Half of the face will be irradiated with AMIⓇ fractional CO₂ laser according to the instrument manual for 20 minutes, succeeded by the topical administration of 1.5 mL 4-fold concentrated ADMSCs secretome. The participants are all instructed not to: (1) wash their face for the next 4 hours; (2) apply sunscreen for the next 1 day; and (3) apply retinoic acid cream for the next 3 days. After the restriction, they should use the mentioned products on daily basis until the next appointment when the protocol is repeated (fourth week). At sixth week, the final skin condition is reevaluated with the same tools, along with the additional variables.

Secretome + Fractional CO₂ Laser

Microneedle DEVICE

Prior to the treatment, each participant will be evaluated for their initial skin status, followed by daily priming with 0.05% retinoic acid cream, applied topically at night for two weeks. At second week, the participants will undergo facial skin anesthesia utilizing 2.5% lidocaine+2.5% prilocaine cream for 30 minutes. The other half of the face will be treated with DrPenⓇ dermapen according to the instrument manual for 20 minutes, succeeded by the topical administration of 1.5 mL 4-fold concentrated ADMSCs secretome. The participants are all instructed not to: (1) wash their face for the next 4 hours; (2) apply sunscreen for the next 1 day; and (3) apply retinoic acid cream for the next 3 days. After the restriction, they should use the mentioned products on daily basis until the next appointment when the protocol is repeated (fourth week). At sixth week, the final skin condition is reevaluated with the same tools, along with the additional variables.

Secretome + Microneedle

Eligibility Criteria

• Age: 35 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female, aged 35-59 years
• Generalized wrinkles on the face
• Consent for the 2-month clinical trial (4 times of follow-up with 2 weeks interval)

You may not qualify if:

• Prior history of hypertrophic scars or keloid formation
• Prior history of allergy to topical anesthetic and/or retinoic acid cream
• Prior history of autoimmune disorders (e.g. systemic lupus erythematosus, rheumatoid arthritis, etc.)
• Prior history of malignancies
• Prior utilization of skincare products for the past 6 months
• Currently under long-term immunosupressants medication (e.g. corticosteroids, biologic agents, cytostatics, etc.)
• Drop-out Criteria:
• Pass away during the clinical trial
• Refrain from the clinical trial before the trial completion
• Absent for more than two days from the scheduled appointment
• Suffer from coronavirus disease 2019 (COVID-19) at any time during the trial
• Experience major adverse event(s) caused by topical products or treatments given in the clinical trial (e.g. allergic drug eruption or contact dermatitis). The participants will receive appropriate management if such event occurs.

Sponsors & Collaborators

• Shannaz Nadia Yusharyahya: lead
• PT. Kimia Farma (Persero) Tbk: collaborator
• Ministry of Education, Culture, Research, and Technology, Republic of Indonesia: collaborator

Study Sites (1)

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Study Officials

• Endi Novianto, MD, PhD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

• Irma Bernadette, MD, PhD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

• Lili Legiawati, MD, PhD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

• Noer Kamila, MD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator (who evaluated the skin aging status, or the outcomes assessor) will be blinded to the treatment allocation until the end of data collection. We cannot perform the masking to the participants as they will surely aware which side of their face receive microneedle or fractional CO₂ laser, even though they are required to close their eyes during treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Geriatric Dermatology Division, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia-dr. Cipto Mangunkusumo Hospital

Model Details: Each participant will receive fractional CO₂ laser treatment on one side of the face and microneedle treatment on the other half. The allocation of which side receive a particular treatment will be determined by a computer programme.

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 19, 2022
• Study Start: August 17, 2022
• Primary Completion: October 26, 2022
• Study Completion: December 31, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)