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Can a new formulation of Botulinum Toxin Type A improve its efficiency over the wrinkles?

Incobotulinumtoxin diluted in zinc gluconate solution for facial wrinkles: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27486491
Enrollment
48
Registered
2017-07-10
Start date
2017-08-16
Completion date
Unknown
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The sample consisted of 48 female participants, over 50 years of age and divided into two groups. The participants were submitted to botulinum toxin application in the upper third of the face, specifically in the frontal muscle, and in 24 participants the dilution of Botulinum Toxin was with 0.02% Zinc Gluconate Solution (Case Group) and 24 participants with dilution Of Botulinum Toxin in 0.9% Physiological Solution (Control Group). Not Applicable

Interventions

Participants are randomly allocated to either the control of the case group. All participants receive doses ranging from 8 to 25 units in the frontal muscle, according to recommendati

Sponsors

Pontifical Catholic University of Rio Grande do Sul (Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS))
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. All female participants 2. 50 years of age or older 3. Agreed to the study and signed the informed consent form 4. No history of chronic gastrointestinal disease (diarrhea, inflammatory bowel disease or celiac disease) with frontal wrinkles 5. Muscle contraction (dynamic) 6. At least 6 months without receiving botulinum toxin application for any indication 7. Participants who were never submitted to this treatment

Exclusion criteria

Exclusion criteria: 1. Individuals of the male gender 2. Female subjects under 50 years of age 3. Did not agree to the study and did not sign the informed consent form 4. History of chronic gastrointestinal disease (diarrhea, inflammatory bowel disease, or Celiac disease) 5. Diabetes mellitus 6. Lack of wrinkles to muscle contraction (dynamic or static) 7. Underwent botulinum toxin treatment for less than 6 months for any indication were not included in the study

Design outcomes

Primary

MeasureTime frame
1. Wrinkle evaluation (on movement and at rest) is measured using the Merz Aesthetics scale at baseline, weeks two, four and 14 2. Quality of life is measured using the WHO Quality of Life score at baseline and week 14

Secondary

MeasureTime frame
There are no secondary outcome measures.

Countries

Brazil

Contacts

Public ContactLeonardo Ferreira
leonardoferreira@doctor.com+55 273 211 0223

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026