Facial Aging, Facial Wrinkles and Rhytides Reduction
Conditions
Keywords
Periocular Rhytids, Facial Wrinkles, Microtoxin, Botulinum Toxin Type A
Brief summary
This study aims to evaluate the efficacy and safety of microdoses of botulinum toxin type A (microtoxin) for improving periocular skin quality and reducing fine wrinkles. Botulinum toxin is commonly used in aesthetic medicine; however, its use in microdoses has been proposed to achieve more natural results with fewer adverse effects. Participants with periocular rhytids will receive intradermal injections of diluted botulinum toxin. Clinical outcomes will include improvement in skin texture, wrinkle reduction, and patient satisfaction. Safety will be assessed by monitoring adverse events. The findings of this study may help determine whether microtoxin is an effective and safe option for minimally invasive periocular rejuvenation.
Detailed description
This prospective interventional study aims to assess the efficacy and safety of intradermal microdoses of botulinum toxin type A (microtoxin) for the treatment of periocular rhytids. The microtoxin technique involves the administration of highly diluted botulinum toxin in small aliquots injected superficially into the dermis, targeting fine wrinkles and improving overall skin quality without significantly affecting muscle function. Participants presenting with periocular dynamic and static rhytids will undergo treatment with standardized microtoxin injections. Clinical evaluation will be performed using validated aesthetic scales, photographic documentation, and patient-reported outcomes. The primary outcome measure will be the degree of wrinkle reduction and improvement in skin texture. Secondary outcomes will include patient satisfaction and incidence of adverse events. Follow-up assessments will be conducted over a defined period to evaluate both efficacy and safety. This study seeks to provide evidence regarding the clinical utility of microtoxin in periocular rejuvenation and to support its use as a minimally invasive alternative to conventional botulinum toxin techniques.
Interventions
Botulinum toxin type A is administered as intradermal microinjections (microtoxin) in the periocular region using a diluted formulation. The injections are performed using a standardized technique targeting superficial dermal layers to improve skin texture and reduce fine wrinkles while minimizing muscle paralysis.
Sponsors
Instituto de Oftalmología Fundación Conde de Valenciana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study with no masking. All participants and investigators are aware of the intervention administered.
Intervention model description
This is a prospective, single-arm interventional study in which all participants receive intradermal microdoses of botulinum toxin type A (microtoxin) for the treatment of periocular rhytids. There is no control group. Clinical outcomes are assessed before and after treatment using standardized evaluation methods, including photographic analysis and patient-reported outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 18 to 35 years * Both male and female participants * Presence of mild to moderate periocular fine wrinkles * Willingness to undergo intradermal botulinum toxin injections * Ability to provide written informed consent
Exclusion criteria
* Previous botulinum toxin treatment in the periocular area within the last 6 months * Known hypersensitivity to botulinum toxin or its components * Active skin infection or dermatologic disease in the treatment area * Neuromuscular disorders * Pregnancy or breastfeeding * Use of medications affecting neuromuscular transmission * History of eyelid or periocular surgery within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sebum production (mm²) from baseline to 6 weeks after intradermal botulinum toxin type A treatment | Baseline and 6 weeks after treatment | The primary outcome is the change in sebum production from baseline to 6 weeks after treatment. Sebum production will be measured using oil-absorbing sheets and quantified as the transparent area in mm² under standardized conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient-reported satisfaction with periocular appearance using FACE-Q | Baseline and 4 weeks after treatment | Patient-reported outcomes will be assessed using the validated FACE-Q questionnaire, evaluating satisfaction with periocular appearance and overall facial aesthetics. |
Countries
Mexico
Outcome results
None listed