A Clinical Study on Pre-operative Intervention With Products During Aesthetic Medicine
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-60
SponsorBotanee Group Co., Ltd.
About this trial
This clinical trial aims to evaluate whether a 14-day pre-operative application of the test product (containing MLYAAT-1002®, a proprietary anti-aging complex) can mitigate skin discomfort during Fotona 4D laser therapy (Frac3 and Piano modes) by comparing clinical evaluation, skin attributes measurement and subject self-assessment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
health females aged 35-60;
subjects with rough dark, loose fine lines;
no history of cosmetic allergies;
subjects are willing to use the test serum on split-face for 28 days;
Disqualifiers
anyone who is pregnant, nursing an infant, or planning a pregnancy during the study;
subjects with known allergies or sensitivities to the ingredients in any of the study products;
any symptoms of facial flushing, erythema, papules, desquamation, or edema as evaluated by a physician prior to initial screening or Fotona4D Pro treatment;
unhealed skin lesions;
Trial design
Design model
Parallel
Treatments tested in this trial
14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatment
Combination productAll enrolled subjects will complete a 14-day washout period followed by a 14-day run-in phase prior to Fotona 4D® laser treatment. During the initial washout phase, participants will exclusively use basic skincare products: sunscreen, cleansing foam, and moisturizing emulsion. Then the subjects will apply the formulations containing MLYAAT-1002® of the active comparator to randomly assigned split-face (the treatment side) for the subsequent 14-day period. Following completion of the product application regimen, all participants will undergo a single session of Fotona 4D laser therapy.
14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatment
Combination productAll enrolled subjects will complete a 14-day washout period followed by a 14-day run-in phase prior to Fotona 4D® laser treatment. During the initial washout phase, participants will exclusively use basic skincare products: sunscreen, cleansing foam, and moisturizing emulsion. Then the subjects will apply the formulations without MLYAAT-1002® of the placebo comparator to randomly assigned split-face (the control side) for the subsequent 14-day period. Following completion of the product application regimen, all participants will undergo a single session of Fotona 4D laser therapy.
Treatment groups
33 Participants
are divided into 2 treatment groupsGroup A: Formulation containing MLYAAT-1002® CompositionActive comparator 1 intervention
Group B: Blank formulation without MLYAAT-1002® CompositionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
changes in the percentage of area in the red zone of facial skin
capturing facial images by VISIA-CR (CANFIELD, America) and analysis the percentage of area in the red zone.
Time frame
Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)2
Self-assessment of the facial state questionnaire
Subjects rated the burning sensation, picotement, pruritus, dysesthesia, tightness,on a five-point scale: 0=Asymptomatic;1=Very mild;2=mild;3=moderate;4=severe
Time frame
Baseline (before Fotona 4D treatment), Timm (immediately after Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)Secondary outcomes
1
changes in transepidermal water loss (TEWL) of facial skin
measuring the loss of water that passes from inside a body through the epidermis to the surrounding atmosphere by Vapometer.
Time frame
D-14(14 days before Fotona 4D treatment), Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)2
changes in skin stratum corneum water content
measuring skin stratum corneum water content by Corneometer CM825 (Courage\&Khazaka，Germany).
Time frame
D-14(14 days before Fotona 4D treatment), Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: