Advertisement

Topics

Safety and Efficacy of the Full Face Applications of Variable Doses of a Commercial Botulinum Toxin Type a (Dysport®)

2014-07-24 14:10:36 | BioPortfolio

Summary

This is an open-label and phase IV study of full face injections of variable doses of BT-A. As it is an open-label and not blind study, both investigator and subjects will know the injection local and doses of the study drug. Patients will be randomized into 3 different groups. Each group will receive a specific dose according with the indication evaluated by the investigator. Six visits will be schedule in this study.

Description

4.2 Methodology

4.2.1 Patient evaluation After providing written informed consent, subject's eligibility will be assessed at a Screening Visit. The subject's general medical history will be recorded. This includes demographic data, history of surgical and cosmetic procedures, dermatological assessment, physical examination, and prior concomitant medications. A pregnancy test will also be performed.

4.2.1.1 Severity of wrinkles

One sub-investigator will rate the wrinkles with the following validated severity scales for the main areas of the face in relaxed mode and under maximal contraction, at visit 0, visits 2 (week 4) and 3 (week 16):

- Clinical 0-3 score for glabellar frown lines7 (Annex 4)

- Photonumeric Atlas for the Assessment of Crow's Feet Severity8 (Annex 5)

- Photonumerical Atlas for the Assessment of Forehead Wrinkle Severity9 (Annex 6)

- Marionette Lines Grading Scale10 (Annex 7)

4.2.1.2 Standard set of photographs will be taken

At Screening , 2, 3, 4 and 5 visits, photographs will be taken:

All the photographs will be taken in a standardized photographic mode with fixed position of the camera. A guideline with examples of standardized photos with delimit standardized positions will be provided to the person responsible to take the photos.

In the photographs, each research subject will be identified by a tag containing a reference to the study, the number of the research subject and the control date. The research subjects should wash their faces before the photographic procedure to remove excess oil and all make up will be removed. All the pictures will be taken at the same room and under same parameters.

The photograph set consist of

- Full face frontal view relaxed;

- One set of photographs relaxed and contracted of each indication that patient will be or was treated in this study.

At the end of the study, two independent evaluators (dermatologists) will assess before and after pictures in a blinded manner. This evaluation will be done to assess the efficacy of BT-A in the injected areas not assessed by the scales.

4.2.3 Evaluation of Quality of Life and patient-reported complains, outcomes and satisfaction Patients will be invited to answer the WHOQoL bref (Annex 2). They will also answer a questionnaire regarding their believes, expectations and spontaneous complaints before and after treatment (Annex 3). This questionnaires will be answered by the patients in the visits: screening, 2, 3, 4 e 5. .

4.2.4 Groups of treatment

Subjects will be assigned to one of the three following treatment groups, according with the total dose received in visit 1:

- Group 1: 30 subjects who received 125 to 170 U of BT-A (Dysport®)

- Group 2: 30 subjects who received 171 to 210 U of BT-A (Dysport®)

- Group 3: 30 subjects who received 211 to 250 U of BT-A (Dysport®)

4.2.5 Reconstitution of the study product and Treatment Administration An independent, experienced and registered pharmacist will be the assigned to carry through the reconstitution of the products. She will prepare the dilutions and the syringes of the product (DYSPORT®) immediately prior to the injections.

The dilutions of DYSPORT® 500 Units per vial will be made with 2 mL of 0.9% sterile saline, using 3 mL syringes and a 21G needle, giving a concentration of 250 Units/mL or 2.5Units/0.01mL of the reconstituted product.

An experienced dermatologist in the use of botulinum toxins (principal investigator - DH) will perform all the injections according to the indications and total number of units that will be injected according to the treatment plan, which aims to obtain the best results. She will only perform the injections and will not participate in other phases of this study.

The application of the BT-A will be made through BD Ultra-fine II 0.3cc syringes, with a 29G needle, 0.5cm in length (short needle).

Immediately after the application, the side effects will be verified and if needed, will be registered and managed.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Dynamic Wrinkles

Intervention

Botulinum toxin

Location

Brazilian Center for Studies in Dermatology
Porto Alegre
Rio Grande do Sul
Brazil
90570-040

Status

Active, not recruiting

Source

Brazilan Center for Studies in Dermatology

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:36-0400

Clinical Trials [563 Associated Clinical Trials listed on BioPortfolio]

Field of Effects of Two Commercial Preparations of Botulinum Toxin Type A

The objective of this study is to compare the field of effects of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as mo...

Comparison of Two Commercial Preparations of Botulinum Toxin Type A

The objective of this study is to compare the action halos of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more d...

Botulinum Toxin for the Treatment of Involuntary Movement Disorders

Botulism is a severe form of food poisoning caused by bacteria. This bacteria produces several toxins one of which is botulinum toxin A. This toxin causes the symptoms of food poisoning....

NT 201 in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines

NT 201 is a Botulinum toxin type A preparation free of complexing proteins. Injected into the muscle, NT 201 causes a reversible local relexation of the injected muscle. Botulinum toxin ty...

Botulinum Toxin (BOTOX) for Cerebral Palsy

This study examines botulinum toxin (BOTOX, or BTX) for the treatment of muscle twitches and spasticity associated with cerebral palsy in children. Botulinum toxin is a naturally occurring...

PubMed Articles [3926 Associated PubMed Articles listed on BioPortfolio]

YouTube Videos on Botulinum Toxin A for Wrinkles: A Useful Resource for Patient Education.

Patients interested in botulinum toxin type A (BTX-A) for wrinkles search for videos on YouTube, but little is known about the quality and reliability of the content.

AbobotulinumtoxinA Efficacy and Safety in Children With Equinus Foot Previously Treated With Botulinum Toxin.

The effects of botulinum toxin are transient, and repeat injections are required in children with lower-limb spasticity. However, the efficacy of botulinum toxin in patients who have received previous...

Primary treatment of early fistula of parotid duct with botulinum toxin type A injection.

Salivary duct injury can be idiopathic, iatrogenic, or post-trauma and may result in sialocele or fistula. Most injuries regress spontaneously and botulinum toxin A is one of several therapeutic possi...

Effects of Botulinum Toxin on Improving Facial Surgical Scars: A Prospective, Split-Scar, Double-Blind, Randomized Controlled Trial.

Early intervention might improve the quality of surgical scars. Botulinum toxin type A has been shown to improve surgical scars in the past decade. The purpose of this study was to evaluate the effect...

Effect of 3 Commercially Available Botulinum Toxin Neuromodulators on Facial Synkinesis: A Randomized Clinical Trial.

Botulinum toxin neuromodulators are an important treatment for facial synkinesis. Whether a difference in efficacy exists among the 3 different botulinum neuromodulators used in treating this conditio...

Medical and Biotech [MESH] Definitions

Subtype of CLOSTRIDIUM BOTULINUM that produces botulinum toxin type C which is neurotoxic to ANIMALS, especially CATTLE, but not humans. It causes dissociation of ACTIN FILAMENTS.

Subtype of CLOSTRIDIUM BOTULINUM that produces botulinum toxin type D which is neurotoxic to ANIMALS, especially CATTLE, but not humans.

Subtype of CLOSTRIDIUM BOTULINUM that produces botulinum toxin type F which is neurotoxic to humans and animals.

Subtype of CLOSTRIDIUM BOTULINUM that produces botulinum toxin type E which is neurotoxic to humans and animals.

Subtype of CLOSTRIDIUM BOTULINUM that produces BOTULINUM TOXIN TYPE A which is neurotoxic to humans and animals.

More From BioPortfolio on "Safety and Efficacy of the Full Face Applications of Variable Doses of a Commercial Botulinum Toxin Type a (Dysport®)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...


Searches Linking to this Trial