Facial AgingMICROTOX-PORENCT07526870
Intradermal Microbotulinum Toxin for Sebum Reduction and Facial Pore Improvement
A study testing Botulinum Toxin Type A (Dysport®) in people with Facial Aging and Facial Wrinkles and Rhytides Reduction, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Aging, Facial Wrinkles and Rhytides Reduction
- What is being tested?
- Botulinum Toxin Type A (Dysport®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 24 Jul 2024to 24 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP
Mexico City
About this study
Official title: Effectiveness of Intradermal Microbotulinum Toxin for the Treatment of Seborrhea and Enlarged Facial Pores: A Prospective Before-and-After Pilot Study
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.
Read the 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.
- Being tested
- Botulinum Toxin Type A (Dysport®)
- Keywords
- Periocular Rhytids, Facial Wrinkles, Microtoxin, Botulinum Toxin Type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Botulinum Toxin Type A (Dysport®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks after treatment
Secondary outcomes (1)
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.
Measured: Baseline and 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start24 Jul 2024
- Primary completion24 Nov 2024
- Study completion24 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526870
- Sponsor's protocol ID
- MICROTOX-SEBUM-CDV-01
- Other IDs
- IOCV-MICROTOX-2024
- Acronym
- MICROTOX-PORE
- Status last verified
- May 2026
- First submitted
- 3 Apr 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intradermal Microbotulinum Toxin for the Treatment of Seborrhea and Enlarged Facial Pores: A Prospective Before-and-After Pilot Study
- ClinicalTrials.gov ID
- NCT07526870
- Acronym / sponsor ID
- MICROTOX-PORE / MICROTOX-SEBUM-CDV-01
- Keywords
- Periocular Rhytids, Facial Wrinkles, Microtoxin, Botulinum Toxin Type A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 24 Nov 2024 (actual)
- Study completion
- 24 Nov 2024 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Microtoxin Treatment | Experimental | Drug: Botulinum Toxin Type A (Dysport®)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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type A (Dysport®)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. | Drug | Microtoxin Treatment |
Primary outcome
Change in sebum production (mm²) from baseline to 6 weeks after intradermal botulinum toxin type A treatment
Time frame: 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.
1 secondary outcome
Change in patient-reported satisfaction with periocular appearance using FACE-Q
Time frame: Baseline and 4 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin Type A (Dysport®) in people with Facial Aging and Facial Wrinkles and Rhytides Reduction, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sebum production (mm²) from baseline to 6 weeks after intradermal botulinum toxin type A treatment (time frame: Baseline and 6 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.