Skin AgingNCT05508191
Microneedle Versus Fractional CO₂ Laser for Skin Aging Treatment With Stem Cell Secretome in Indonesian Adult Women
A study testing Fractional CO₂ Laser and Microneedle in people with Skin Aging and Transepidermal Water Loss, run by Shannaz Nadia Yusharyahya at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Transepidermal Water Loss
- What is being tested?
- Fractional CO₂ Laser and Microneedle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Aug 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.)
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- 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 locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Microneedling Versus Fractional CO₂ Laser Resurfacing for Skin Rejuvenation With Adipose-derived Mesenchymal Stem Cells Secretome: a Single-blind, Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Skin Aging, Transepidermal Water Loss
- Being tested
- Fractional CO₂ Laser, Microneedle
- Keywords
- Adipose-derived mesenchymal stem cells, Fractional CO₂ laser, Microneedling, Secretome, Skin rejuvenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO₂ LaserDevice
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.
MicroneedleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Microneedle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Week 6 (end of trial)
Visual analog scale (VAS) of pain for the convenience degree
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.
Measured: Week 6 (end of trial)
Number of adverse events experienced during the clinical trial
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.
Measured: Week 2 thirty minutes after intervention, week 4 thirty minutes after intervention, week 6 (end of trial)
Subjective preference to treatment
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
Measured: Week 6 (end of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start17 Aug 2022
- Primary completion26 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shannaz Nadia Yusharyahya
- Sponsor type
- University, hospital or other
- Collaborators
- PT. Kimia Farma (Persero) Tbk, Ministry of Education, Culture, Research, and Technology, Republic of Indonesia
- Responsible party
- Sponsor-investigator, Shannaz Nadia Yusharyahya, Universitas Indonesia
- Investigators
- Endi Novianto, MD, PhD, Principal investigator, Fakultas Kedokteran Universitas IndonesiaIrma Bernadette, MD, PhD, Principal investigator, Fakultas Kedokteran Universitas IndonesiaLili Legiawati, MD, PhD, Principal investigator, Fakultas Kedokteran Universitas IndonesiaNoer Kamila, MD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508191
- Sponsor's protocol ID
- 22-08-0682
- Status last verified
- Feb 2023
- First submitted
- 17 Aug 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling Versus Fractional CO₂ Laser Resurfacing for Skin Rejuvenation With Adipose-derived Mesenchymal Stem Cells Secretome: a Single-blind, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05508191
- Acronym / sponsor ID
- 22-08-0682
- Conditions
- Skin Aging, Transepidermal Water Loss
- Keywords
- Adipose-derived mesenchymal stem cells, Fractional CO₂ laser, Microneedling, Secretome, Skin rejuvenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shannaz Nadia YusharyahyaUniversity, hospital or other
- Collaborators
- PT. Kimia Farma (Persero) Tbk, Ministry of Education, Culture, Research, and Technology, Republic of Indonesia
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Secretome + Fractional CO₂ Laser | Experimental | Device: Fractional CO₂ LaserThis 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. |
| Secretome + Microneedle | Experimental | Device: MicroneedleThis 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. |
Who may qualify
- Ages
- 35 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional CO₂ LaserPrior 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 | Secretome + Fractional CO₂ Laser |
| MicroneedlePrior 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. | Device | Secretome + Microneedle |
Primary outcome
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)
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.
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)
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.
Skin capacitance evaluated by the CorneometerⓇ
Time frame: Week 0 (baseline), week 2 before intervention, week 4 before intervention, week 6 (end of trial)
Total water content in the stratum corneum of the skin, reported in microsiemens. *This is a numeric variable.
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)
Water evaporation rate in a given area of skin, reported in gram/m²/hour. *This is a numeric variable.
4 secondary outcomes
Likert scale for the satisfaction degree
Time frame: Week 6 (end of trial)
Visual analog scale (VAS) of pain for the convenience degree
Time frame: Week 6 (end of trial)
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)
Subjective preference to treatment
Time frame: Week 6 (end of trial)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Endi Novianto, MD, PhD principal investigator
Fakultas Kedokteran Universitas Indonesia
Irma Bernadette, MD, PhD principal investigator
Fakultas Kedokteran Universitas Indonesia
Lili Legiawati, MD, PhD principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional CO₂ Laser and Microneedle in people with Skin Aging and Transepidermal Water Loss, run by Shannaz Nadia Yusharyahya at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.