Plain English Summary
Background and study aims
Botulinum toxin injections, also known as Botox or Dysport, are treatments that are injected to relax muscles. This is usually injected in to the face to improve the look of wrinkles. The botulinum toxin needs to be mixed with a saline to be reconstituted (restoring something dried by adding water or saline (salt water)). This can be done with different types of saline solutions, including sodium chloride or zinc gluconate. The aim of this study is to compare the effect of botulinum toxin treatments diluted with different compounds to see if they are effective.
Who can participate?
Females aged 50 and older who have not received botulinum toxin injections for the last six months.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the treatment that is diluted with sodium chloride. Participants receive the treatment that is diluted with zinc gluconate. Participants receive a range from 8 to 25 units in their forehead. Participants are followed up two, four and 14 weeks after being treated to assess their wrinkles and quality of life.
What are the possible benefits and risks of participating?
Participants may benefit from improvements in the wrinkles. There are risks of scratches, asymmetry, pain (at application), edema (swelling), ineffectiveness and ecchymosis.
Where is the study run from?
Pontifical Catholic University of Rio Grande do Sul (Brazil)
When is the study starting and how long is it expected to run for?
March 2014 to February 2018
Who is funding the study?
Investigator initiated and funded (Brazil)
Who is the main contact?
Dr Leonardo Ferreira
leonardoferreira@doctor.com
Trial website
Contact information
Type
Public
Primary contact
Dr Leonardo Ferreira
ORCID ID
Contact details
Shopping Mestre Álvaro
Avenida João Palácios
300
Piso L2
Torre A
Salas
409-412
Serra-ES
29160161
Brazil
+55 273 211 0223
leonardoferreira@doctor.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0
Study information
Scientific title
Incobotulinumtoxin diluted in zinc gluconate solution for facial wrinkles: randomized clinical trial
Acronym
Study hypothesis
Null hypothesis:
The effect of injecting the diluted botulinum toxin in 0.9% sodium chloride physiological solution has the same duration as the injection of botulinum toxin diluted in 0.02% zinc gluconate in the frontal muscle.
Hypothesis:
The effect of injection of botulinum toxin diluted in 0.02% zinc gluconate has a longer duration than the injection of botulinum toxin diluted in saline solution only 0.9% sodium chloride in the frontal muscle.
Ethics approval
Research Ethics Committee of PUCRS, 09/12/2014, ref: 903.330
Study design
Prospective double-blind randomised longitudinal case/control study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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).
Intervention
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 recommendations of application in this region.
Participants in the control group receive a toxin diluted in 0.9% sodium chloride in each spot.
Participants in the case group receive the treatment toxin diluted in 0.02% zinc gluconate.
Participants receive the treatment once and then receive follow up on week two, four and 14 to assess their wrinkles and quality of life.
Intervention type
Other
Phase
Drug names
Primary outcome measures
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 outcome measures
There are no secondary outcome measures.
Overall trial start date
02/03/2014
Overall trial end date
07/02/2018
Reason abandoned
Eligibility
Participant 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
Participant type
Other
Age group
Mixed
Gender
Female
Target number of participants
The sample consisted of 48 female participants, over 50 years of age and divided into two groups.
Participant 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
Recruitment start date
16/08/2017
Recruitment end date
22/11/2017
Locations
Countries of recruitment
Brazil
Trial participating centre
Pontifical Catholic University of Rio Grande do Sul
Ipiranga Avenue
6681 Partenon
Porto Alegre
90619-900
Brazil
Sponsor information
Organisation
Pontifical Catholic University of Rio Grande do Sul (Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS))
Sponsor details
Instituto de Geriatria e Gerontologia
Av. Ipiranga
6681
Prédio 81 - sala 703
Porto Alegre
90619-900
Brazil
+55 5133 536031
geronbio@pucrs.br
Sponsor type
Other
Website
Funders
Funder type
Not defined
Funder name
Investigator initated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration.
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/08/2018
Participant level data
Not expected to be available
Results - basic reporting
Publication summary