Intradermal Microbotulinum Toxin for Sebum Reduction and Facial Pore Improvement

NCT07526870 | Completed DMC

• 2 other identifiers: MICROTOX-SEBUM-CDV-01IOCV-MICROTOX-2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Aging; Facial Wrinkles and Rhytides Reduction

Keywords

Periocular Rhytids; Facial Wrinkles; Microtoxin; Botulinum Toxin Type A

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in patient-reported satisfaction with periocular appearance using FACE-Q

  Baseline and 4 weeks after treatment

Study Arms (1)

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.

Drug: Botulinum Toxin Type A (Dysport®)

Interventions

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.

Microtoxin Treatment

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP

Mexico City, Mexico

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study with no masking. All participants and investigators are aware of the intervention administered.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 13, 2026
• Study Start: July 24, 2024
• Primary Completion: November 24, 2024
• Study Completion: November 24, 2024
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)