Microneedle Versus Fractional CO₂ Laser for Skin Aging Treatment With Stem Cell Secretome in Indonesian Adult Women
Condition: Skin Aging; Transepidermal Water Loss
Study type: Interventional

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.
    

Intervention name(s): Fractional CO₂ Laser; Microneedle
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adipose-derived mesenchymal stem cells; Fractional CO₂ laser; Microneedling; Secretome; Skin rejuvenation