Microneedling Versus Fractional CO₂ Laser Resurfacing for Skin Rejuvenation With Adipose-derived Mesenchymal Stem Cells Secretome: a Single-blind, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Skin aging changes evaluated by dermoscopy photoaging scale (DPAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 35 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Fractional CO₂ Laser (Device)
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.
干预措施: Microneedle (Device)
结局指标
主要结局
Skin aging changes evaluated by dermoscopy photoaging scale (DPAS)
时间窗: 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
时间窗: 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Ⓡ
时间窗: 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Ⓡ
时间窗: 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.
次要结局
- Likert scale for the satisfaction degree(Week 6 (end of trial))
- Visual analog scale (VAS) of pain for the convenience degree(Week 6 (end of trial))
- Number of adverse events experienced during the clinical trial(Week 2 thirty minutes after intervention, week 4 thirty minutes after intervention, week 6 (end of trial))
- Subjective preference to treatment(Week 6 (end of trial))
研究者
Shannaz Nadia Yusharyahya
Head of Geriatric Dermatology Division, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia-dr. Cipto Mangunkusumo Hospital
Indonesia University