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

Shannaz Nadia Yusharyahya

Status: Completed

Conditions: Skin Aging; Transepidermal Water Loss

Treatments: Device: Microneedle; Device: Fractional CO₂ Laser

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05508191

22-08-0682

Details and patient eligibility

About

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.

Full description

A single-blind, randomized clinical trial will be conducted upon thirty females (aged 35-59 years old) presented with signs of generalized facial cutaneous senescence. Their initial skin status will be evaluated utilizing dermoscopy photoaging scale (DPAS) and Janus-3® skin analyzer, along with skin capacitance using the Corneometer® and transepidermal water loss using the Tewameter®, followed by daily priming with 0.05% retinoic acid for two consecutive weeks. At second and fourth week, the participants are subjected to microneedle and fractional CO₂ laser according to the respective protocol in split-face fashion, which the randomization will be determined by a computer programme. Succeeding the treatment, four-fold concentrated ADMSCs secretome will be administered topically to the both sides of face. The final skin condition will ultimately be recorded at the sixth week, along with their satisfaction and convenience degree, the adverse events experienced during the trial, and subjective preference to the treatment. Appropriate statistical analyses will subsequently be performed at the significance level of 0.05.

Enrollment: 30 patients

Sex: Female

Ages: 35 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Secretome + Fractional CO₂ Laser

Experimental group

Description:

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.

Treatment:

Device: Fractional CO₂ Laser

Secretome + Microneedle

Experimental group

Description:

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.

Treatment:

Device: Microneedle