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OpenTrials
Completed

NCT Number: NCT07526870

Intradermal Microbotulinum Toxin for Sebum Reduction and Facial Pore Improvement

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP

Mexico City, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Official study title

Effectiveness of Intradermal Microbotulinum Toxin for the Treatment of Seborrhea and Enlarged Facial Pores: A Prospective Before-and-After Pilot Study

Acronym: MICROTOX-PORE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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