- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05508191
Microneedle Versus Fractional CO₂ Laser for Skin Aging Treatment With Stem Cell Secretome in Indonesian Adult Women
Microneedling Versus Fractional CO₂ Laser Resurfacing for Skin Rejuvenation With Adipose-derived Mesenchymal Stem Cells Secretome: a Single-blind, Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Faculty of Medicine, Universitas Indonesia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Secretome + Fractional CO₂ Laser
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.
|
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.
|
EXPERIMENTAL: Secretome + Microneedle
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin aging changes evaluated by dermoscopy photoaging scale (DPAS)
Time Frame: Week 0 (baseline), week 2 before intervention, week 4 before intervention, week 6 (end of trial)
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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)
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Skin aging changes evaluated by Janus-3Ⓡ skin analyzer
Time Frame: Week 0 (baseline), week 2 before intervention, week 4 before intervention, week 6 (end of trial)
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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)
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Skin capacitance evaluated by the CorneometerⓇ
Time Frame: Week 0 (baseline), week 2 before intervention, week 4 before intervention, week 6 (end of trial)
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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)
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Transepidermal water loss evaluated by the TewameterⓇ
Time Frame: Week 0 (baseline), week 2 before intervention, week 4 before intervention, week 6 (end of trial)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Likert scale for the satisfaction degree
Time Frame: Week 6 (end of trial)
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An interval of 0 (extremely unsatisfied) to 10 (extremely satisfied) for determination of the participants' satisfaction upon both treatments (microneedle and fractional CO₂ laser). *This is a numeric variable. |
Week 6 (end of trial)
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Visual analog scale (VAS) of pain for the convenience degree
Time Frame: Week 6 (end of trial)
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An interval of 0 (no pain whatsoever) to 10 (the most extreme pain possible) for determination of the participants' convenience during the trial with both treatments (microneedle and fractional CO₂ laser). *This is a numeric variable. |
Week 6 (end of trial)
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Number of adverse events experienced during the clinical trial
Time Frame: Week 2 thirty minutes after intervention, week 4 thirty minutes after intervention, week 6 (end of trial)
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Side effects experienced by the participants following the application of topical products (facial wash, sunscreen, anesthetic cream, and retinoic acid cream) and procedures (microneedle and fractional CO₂ laser), such as erythema, warmth, itch, burning sensation, edema, peeled skin, and/or no adverse events, reported in frequency of each event. Each participant will be contacted one day after each treatment for side effect evaluation. They can also report any events experienced to the investigator at any time during the trial. *This is a categorical variable. |
Week 2 thirty minutes after intervention, week 4 thirty minutes after intervention, week 6 (end of trial)
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Subjective preference to treatment
Time Frame: Week 6 (end of trial)
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Preference of each subject towards a particular treatment (microneedling or fractional CO2 laser) based on their experience during the trial *This is a categorical variable |
Week 6 (end of trial)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 22-08-0682
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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