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

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

Interventions

DEVICE

Fractional CO₂ Laser

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.

DEVICE

Microneedle

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.

Sponsors & Collaborators

• PT. Kimia Farma (Persero) Tbk

  collaborator INDUSTRY

• Ministry of Education, Culture, Research, and Technology, Republic of Indonesia

  collaborator UNKNOWN

• Shannaz Nadia Yusharyahya

  lead OTHER

Principal Investigators

• Endi Novianto, MD, PhD · Fakultas Kedokteran Universitas Indonesia

• Irma Bernadette, MD, PhD · Fakultas Kedokteran Universitas Indonesia

• Lili Legiawati, MD, PhD · Fakultas Kedokteran Universitas Indonesia

• Noer Kamila, MD · Fakultas Kedokteran Universitas Indonesia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

59 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-08-17

Primary Completion

2022-10-26

Completion

2022-12-31

Countries

• Indonesia

Study Locations