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| Name | Class |
|---|---|
| PT. Kimia Farma (Persero) Tbk | INDUSTRY |
| Ministry of Education, Culture, Research, and Technology, Republic of Indonesia | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional CO₂ Laser | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Week 0 (baseline), week 2 before intervention, week 4 before intervention, week 6 (end of trial) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 6 (end of trial) |
| Visual analog scale (VAS) of pain for the convenience degree |
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Inclusion Criteria:
Exclusion Criteria:
Drop-out Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Endi Novianto, MD, PhD | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Irma Bernadette, MD, PhD | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Lili Legiawati, MD, PhD | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Noer Kamila, MD | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Universitas Indonesia | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
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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.
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The investigator (who evaluated the skin aging status, or the outcomes assessor) will be blinded to the treatment allocation until the end of data collection. We cannot perform the masking to the participants as they will surely aware which side of their face receive microneedle or fractional CO₂ laser, even though they are required to close their eyes during treatment.
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| Microneedle | Device | 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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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) |
| 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. | 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 | Week 6 (end of trial) |