Condition category
Not Applicable
Date applied
03/07/2017
Date assigned
10/07/2017
Last edited
10/07/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.pucrs.br/igg-acad/

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

Publication citations

Additional files

Editorial Notes