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| ID | Type | Description | Link |
|---|---|---|---|
| IOCV-MICROTOX-2024 | Other Identifier | IOCV-MICROTOX-2024 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microtoxin Treatment | Experimental | Participants receive intradermal microdoses of botulinum toxin type A (microtoxin) administered in the periocular region for the treatment of fine wrinkles and improvement of skin quality. The intervention consists of diluted botulinum toxin injected superficially using a standardized technique. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A (Dysport®) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sebum production (mm²) from baseline to 6 weeks after intradermal botulinum toxin type A 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. | Baseline and 6 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient-reported satisfaction with periocular appearance using FACE-Q | Patient-reported outcomes will be assessed using the validated FACE-Q Satisfaction with Facial Appearance scale (0-100), which evaluates satisfaction with periocular appearance and overall facial aesthetics. Higher scores indicate greater patient satisfaction and better aesthetic outcomes. | Baseline and 4 weeks after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ✔ Instituto de OftalmologÃa Fundación Conde de Valenciana IAP | Mexico City | Mexico |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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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.
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This is an open-label study with no masking. All participants and investigators are aware of the intervention administered.
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|
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |