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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Brazilan Center for Studies in Dermatology.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier:
NCT01032954
First received: December 15, 2009
Last updated: July 6, 2010
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Dynamic Wrinkles
Drug: Botulinum toxin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Iv Study On The Safety And Efficacy Of The Full Face Applications Of Variable Doses Of 125 To 250 Units Of A Commercial Botulinum Toxin Type A (Dysport®)

Resource links provided by NLM:


Further study details as provided by Brazilan Center for Studies in Dermatology:

Primary Outcome Measures:
  • Whoqol(Quality of life questionaire) [ Time Frame: Visit 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Photographs evaluation - independent dermatologists [ Time Frame: Visit 2 (week 4) ] [ Designated as safety issue: No ]
  • Photographs evaluation - independent dermatologists [ Time Frame: Visit 3 (week 16) ] [ Designated as safety issue: No ]
  • Photographs evaluation - independent dermatologists [ Time Frame: visit 4 (week 20) ] [ Designated as safety issue: No ]
  • Photographs evaluation - independent dermatologists [ Time Frame: visit 5 (week 24) ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 125 to 170 U of BT-A Drug: Botulinum toxin

The following list shows the indications for eligibility and total doses that will be applied in each part of the face, according to the consensus meeting recommendations, at the 1 visit:

Upper face:

  • Crow's feet wrinkles - 70 U
  • Glabella - 50 U
  • Forehead - 40 U

Mid face:

  • Lower eyelid - 5 U
  • Nasal wrinkles - 20 U
  • Malar wrinkles - 10 U

Lower face:

  • Peri-oral wrinkles - 15U
  • Asymmetric smile or gummy smile - 5U
  • "Cellulitic chin" - 20U
  • Marionette lines - 25 U According to the patients needs, the doses can vary ±10% in terms of the amount of units that will be injected.

Patients will be allocated in each group according to the total dose received at visit 1(described above). At visit 2, all the patients will receive a touch-up of a standard dose of 25 Units of Dysport®, distributed on the treated areas according patient's needs.

Active Comparator: 171 to 210 U of BT-A Drug: Botulinum toxin

The following list shows the indications for eligibility and total doses that will be applied in each part of the face, according to the consensus meeting recommendations, at the 1 visit:

Upper face:

  • Crow's feet wrinkles - 70 U
  • Glabella - 50 U
  • Forehead - 40 U

Mid face:

  • Lower eyelid - 5 U
  • Nasal wrinkles - 20 U
  • Malar wrinkles - 10 U

Lower face:

  • Peri-oral wrinkles - 15U
  • Asymmetric smile or gummy smile - 5U
  • "Cellulitic chin" - 20U
  • Marionette lines - 25 U According to the patients needs, the doses can vary ±10% in terms of the amount of units that will be injected.

Patients will be allocated in each group according to the total dose received at visit 1(described above). At visit 2, all the patients will receive a touch-up of a standard dose of 25 Units of Dysport®, distributed on the treated areas according patient's needs.

Active Comparator: 211 to 250 U of BT-A Drug: Botulinum toxin

The following list shows the indications for eligibility and total doses that will be applied in each part of the face, according to the consensus meeting recommendations, at the 1 visit:

Upper face:

  • Crow's feet wrinkles - 70 U
  • Glabella - 50 U
  • Forehead - 40 U

Mid face:

  • Lower eyelid - 5 U
  • Nasal wrinkles - 20 U
  • Malar wrinkles - 10 U

Lower face:

  • Peri-oral wrinkles - 15U
  • Asymmetric smile or gummy smile - 5U
  • "Cellulitic chin" - 20U
  • Marionette lines - 25 U According to the patients needs, the doses can vary ±10% in terms of the amount of units that will be injected.

Patients will be allocated in each group according to the total dose received at visit 1(described above). At visit 2, all the patients will receive a touch-up of a standard dose of 25 Units of Dysport®, distributed on the treated areas according patient's needs.


  Hide Detailed Description

Detailed 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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Written Informed Consent;
  2. Subjects aged between 30 and 60 years;
  3. Skin Fitzpatrick Phototypes I to VI;
  4. Subjects that never received BT-A or who had previous injections of BT-A in no more than one third of the face with in the last 6 months;
  5. Subjects presenting at least two indications for treatment with BT-A in each third of the face;
  6. Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the product under investigation;
  7. Subjects of childbearing age should present a negative urine pregnancy test (instant test) at baseline and should be using an effective contraceptive method (oral or injectable contraceptive, for at last three months, and use of preservative; subjects with: hysterectomy, oophorectomy or tubal ligation);
  8. Availability of the patient throughout the duration of the study (24 weeks);
  9. Subjects that agree not to undergo other cosmetic or dermatological procedures during the study;
  10. Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by the study protocol.

Exclusion Criteria:

  1. Pregnant women or women intending to become pregnant during the study;
  2. Subjects participating in other clinical trials;
  3. Presence of scars on the face that may interfere with the result of study;
  4. Subjects with neoplastic, muscular or neurological diseases;
  5. Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics.
  6. Subjects with inflammation or active infection in the face;
  7. Subjects with a history of sensitivity to the components of the formula;
  8. Subjects with prior history of eyelid ptosis; marked facial asymmetry, excessive dermatochalasis, deep dermal scarring or thick sebaceous skin.
  9. Subjects presenting myasthenia gravis, Eaton-Lambert Syndrome and motor neuron diseases;
  10. Subjects with coagulation disorders or using anticoagulants;
  11. Subjects with known systemic autoimmune diseases;
  12. Subjects clinically diagnosed anxiety disorder or any significant psychiatric disorder (e.g. depression) that, in the opinion of the Evaluator, might interfere with the Subject's participation in the study;
  13. Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032954

Locations
Brazil
Brazilian Center for Studies in Dermatology
Porto Alegre, Rio Grande do Sul, Brazil, 90570-040
Sponsors and Collaborators
Brazilan Center for Studies in Dermatology
Investigators
Principal Investigator: Doris M Hexsel, MD Brazilian Center for Studies in Dermatology
  More Information

No publications provided

Responsible Party: Doris M Hexsel, Brazilian Center for Studies in Dermatology
ClinicalTrials.gov Identifier: NCT01032954     History of Changes
Other Study ID Numbers: 01-CBED09-02
Study First Received: December 15, 2009
Last Updated: July 6, 2010
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research

Keywords provided by Brazilan Center for Studies in Dermatology:
Botulinum Toxin
Rejuvenation
Facial dynamic wrinkles

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014