Clinical trial NCT05508191: Microneedle Versus Fractional CO₂ Laser for Skin Aging Treatment With Stem Cell Secretome in Indonesian Adult Women
Official title: Microneedling Versus Fractional CO₂ Laser Resurfacing for Skin Rejuvenation With Adipose-derived Mesenchymal Stem Cells Secretome: a Single-blind, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Transepidermal Water Loss
Keywords: Adipose-derived mesenchymal stem cells
Fractional CO₂ laser
Microneedling
Secretome
Skin rejuvenation
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: PT. Kimia Farma (Persero) Tbk
name: Ministry of Education, Culture, Research, and Technology, Republic of Indonesia
First posted: 2022-08-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Skin aging changes evaluated by dermoscopy photoaging scale (DPAS)
timeFrame: Week 0 (baseline), week 2 before intervention, week 4 before intervention, week 6 (end of trial)
measure: Skin aging changes evaluated by Janus-3Ⓡ skin analyzer
timeFrame: Week 0 (baseline), week 2 before intervention, week 4 before intervention, week 6 (end of trial)
measure: Skin capacitance evaluated by the CorneometerⓇ
timeFrame: Week 0 (baseline), week 2 before intervention, week 4 before intervention, week 6 (end of trial)
measure: Transepidermal water loss evaluated by the TewameterⓇ
timeFrame: Week 0 (baseline), week 2 before intervention, week 4 before intervention, week 6 (end of trial)
Secondary outcomes:
measure: Likert scale for the satisfaction degree
timeFrame: Week 6 (end of trial)
measure: Visual analog scale (VAS) of pain for the convenience degree
timeFrame: Week 6 (end of trial)
measure: Number of adverse events experienced during the clinical trial
timeFrame: Week 2 thirty minutes after intervention, week 4 thirty minutes after intervention, week 6 (end of trial)
measure: Subjective preference to treatment
timeFrame: Week 6 (end of trial)
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Faculty of Medicine, Universitas Indonesia
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Endi Novianto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Irma Bernadette, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Lili Legiawati, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Noer Kamila, MD
role: PRINCIPAL_INVESTIGATOR
References: