Thai female volunteers aged 35-70 years with mild to severe wrinkles in the decolletage area (ranging from level 2 to level 5) according to the Five-point Fabi/Bolton Chest Wrinkle Scale Centerless Focused Ultrasound High Intensity Focused Ultrasound Decolletage Decollete
Conditions
Interventions
A total of 400 treatment points will be applied per 16 cm2 (4x4 cm) area, using 2-3 different transducer heads depending on the thickness of the participant'
s skin.
The measurement of skin thickness will be taken at the central decolletage area, specifically 2 cm above an imaginary line drawn from the axillary fold. Skin is considered thick if it can be p
Experimental Device
Centerless Focused Ultrasound
Sponsors
Aesla co., ltd
Eligibility
Sex/Gender
Female
Age
35 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Female participants, aged between 35 and 70 years, with mild to severe wrinkles in the decolletage area (ranging from level 2 to level 5) according to the Five-point Fabi/Bolton Chest Wrinkle Scale. 2.Participation is voluntary, with individuals willingly agreeing to collaborate and provide consent to be involved in the research study.
Exclusion criteria
Exclusion criteria: 1. The research participant is pregnant, breastfeeding, or planning to become pregnant during the study period. 2. The research participant has a history of cancer in the thoracic region or nearby areas. 3. The research participant has a pacemaker, metal implants, or silicone augmentation in the chest area. 4. The research participant has skin conditions such as rashes, dermatitis, open wounds, or severe acne in the chest area. 5. The research participant has a history of herpes infection in the chest area. 6. The research participant has a connective tissue disorder. 7. The research participant has a blood coagulation disorder or is taking medication that affects blood clotting, such as Warfarin or Aspirin. 8. The research participant has received Botox (BTX-A), dermal fillers, or other treatments such as anti-wrinkle creams in the chest area within the past six months. 9. The research participant is consuming collagen-boosting supplements, such as collagen extracts. 10. The research participant is taking non-steroidal anti-inflammatory drugs (NSAIDs) or steroid medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of research participants who achieve an improvement of at least one point on the Fabi/Bolton Chest Wrinkle Scale at week 12 at week 12 after the intervention Fabi/Bolton Chest Wrinkle Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain score at 30 minutes after the intervention validated 11-point (0-10) Numeric Rating Scale,Adverse effects at week 1 after the intervention checklists such as redness, swelling, bruising, or hyperpigmentation ,Decolletge skin wrinkle score baseline and at week 4 and 12 after the intervention Fabi/Bolton Chest Wrinkle Scale score ,Aesthetic Improvement Scale at week 4 and 12 after the intervention Clinician Global Aesthetic Improvement Scale (CGAIS) score ,satisfaction score at week 12 after the intervention Participant satisfaction questionnaire | — |
Countries
Thailand
Contacts
Public ContactChutimon Panyaparabordee
Dhurakij Pundit University
Outcome results
None listed