Intradermal Microbotulinum Toxin for Sebum Reduction and Facial Pore Improvement (MICROTOX-PORE)

May 21, 2026 updated by: Instituto de Oftalmología Fundación Conde de Valenciana

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico
        • ✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microtoxin Treatment
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient-reported satisfaction with periocular appearance using FACE-Q
Time Frame: Baseline and 4 weeks after treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2024

Primary Completion (Actual)

November 24, 2024

Study Completion (Actual)

November 24, 2024

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MICROTOX-SEBUM-CDV-01
  • IOCV-MICROTOX-2024 (Other Identifier: IOCV-MICROTOX-2024)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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