Skin Aging Clinical Trial
Official title:
Microneedling Versus Fractional CO₂ Laser Resurfacing for Skin Rejuvenation With Adipose-derived Mesenchymal Stem Cells Secretome: a Single-blind, Randomized Clinical Trial
Verified date | February 2023 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 31, 2022 |
Est. primary completion date | October 26, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 35 Years to 59 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Faculty of Medicine, Universitas Indonesia | Jakarta Pusat | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Shannaz Nadia Yusharyahya | Ministry of Education, Culture, Research, and Technology, Republic of Indonesia, PT. Kimia Farma (Persero) Tbk |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Secondary | 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) | |
Secondary | 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. |
Week 6 (end of trial) | |
Secondary | 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) | |
Secondary | 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) |
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