CClinicalTrials.gg
Sign In
CompletedNCT01032954Updated Oct 14, 2020Results posted

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

A Phase 4 interventional study of Botulinum toxin in Sun-induced Wrinkles, sponsored by Brazilan Center for Studies in Dermatology. Completed at 1 site in Brazil. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-14.

Sponsored by Brazilan Center for Studies in Dermatology · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study summary

This is an open-label and phase IV study of full face injections of variable doses of botulinum toxin type A (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.

Read the 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 at Baseline, Week 4, Week 8, Week 16 and Week 24:

  • Clinical 0-3 score for standardized assessment of facial wrinkles in the glabella area (from GLADYS study)
  • Photometric Atlas for the Assessment of Crow's Feet Severity
  • Facial Wrinkle Scale, for forehead lines (Carruthers A, et al. Dermatol Surg. 2003;29(5):461-7)

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 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®)

4.2.4 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 21 gauge needle, giving a concentration of 250 units/mL or 2.5 units/0.01 mL 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 with Becton, Dickinson and Company (BD) Ultra-fine II 0.3 cc syringes, with a 29 gauge needle, 0.5 cm in length (short needle).

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

02

Conditions studied

  • Sun-induced Wrinkles

Keywords

  • Botulinum Toxin
  • Rejuvenation
  • Facial dynamic wrinkles
03

In context

Lead sponsor

Brazilan Center for Studies in Dermatology is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    125 to 170 IU of "'Botulinum toxin' "

    group with intervention of 125 to 170 IU of 'Botulinum toxin'

    Drug: Botulinum toxin

  • Active comparator
    171 to 210 IU of 'Botulinum toxin'

    Patients who have received 171 to 210 IU of 'Botulinum toxin'

    Drug: Botulinum toxin

  • Active comparator
    211 to 250 IU of Botulinum toxin

    Patients who have received 211 to 250 U of Botulinum toxi'

    Drug: Botulinum toxin

Interventions

  • DrugBotulinum toxin

    Drug: Botulinum toxin Indications for eligibility and total doses that will be applied in each part of the face, at visit 1: Upper face: * Crow's feet wrinkles - 70 units * Glabella - 50 units * Forehead - 40 units Mid face: * Lower eyelid - 5 units * Nasal wrinkles - 20 units * Malar wrinkles - 10 units Lower face: * Peri-oral wrinkles - 15 units * Asymmetric smile or gummy smile - 5 units * "Cellulitic chin" - 20 units * 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 and receive the doses described above at visit 1. At visit 2, all the patients will receive a touch-up of a standard dose of 25 U, distributed on the treated areas according patient's needs.

    Also known as: Dysport

06

What researchers measure

Primary outcomes

  1. Wrinkles' Severity (Forehead)

    Facial Wrinkle Scale: 0 - none, 1 - mild; 2 - moderate; 3 - severe

    Time frame: Baseline; Week 4; Week 16; Week 20; Week 24

  2. Wrinkles' Severity (Glabella)

    GLADYS study Atlas: 0 - no wrinkles, 1 - mild wrinkles; 2 - moderate wrinkles; 3 - severe wrinkles

    Time frame: Baseline; Week 4; Week 16; Week 20; Week 24

  3. Wrinkles' Severity (Periocular [Crow's Feet])

    Photonumeric Atlas for the Assessment of Crow's Feet Severity: 0 - none, 1 - mild; 2 - moderate; 3 - severe

    Time frame: Baseline; Week 4; Week 16; Week 20; Week 24

07

Results

Posted Sep 17, 2020

Participant flow

Participant flow — Overall Study
Milestone125 to 170 Units of Botulinum Toxin Type A171 to 210 Units of Botulinum Toxin Type A211 to 250 Units of Botulinum Toxin Type A
Started303030
Completed262930
Not completed410

Outcome measures

PrimaryWrinkles' Severity (Forehead)

Facial Wrinkle Scale: 0 - none, 1 - mild; 2 - moderate; 3 - severe

Time frame:
Baseline; Week 4; Week 16; Week 20; Week 24
Reported as:
Mean · units on a scale
Wrinkles' Severity (Forehead)
units on a scale125 to 170 Units of Botulinum Toxin Type A171 to 210 Units of Botulinum Toxin Type A211 to 250 Units of Botulinum Toxin Type A
Baseline2.31 ± 0.842.66 ± 0.492.60 ± 0.68
Week 41.78 ± 0.441.33 ± 0.700.93 ± 0.70
Week 161.82 ± 0.752.15 ± 0.751.96 ± 0.66
Week 202.25 ± 0.892.48 ± 0.682.32 ± 0.61
Week 242.44 ± 0.882.58 ± 0.582.48 ± 0.63
Statistical analysis
  • 125 to 170 Units of Botulinum Toxin Type A vs 171 to 210 Units of Botulinum Toxin Type A vs 211 to 250 Units of Botulinum Toxin Type A · GLM= GENERAL LINEAR MODELS WITH REPEATED · p = <0.05 (P-value threshold for significance: \<0.05)
PrimaryWrinkles' Severity (Glabella)

GLADYS study Atlas: 0 - no wrinkles, 1 - mild wrinkles; 2 - moderate wrinkles; 3 - severe wrinkles

Time frame:
Baseline; Week 4; Week 16; Week 20; Week 24
Reported as:
Mean · units on a scale
Wrinkles' Severity (Glabella)
units on a scale125 to 170 Units of Botulinum Toxin Type A171 to 210 Units of Botulinum Toxin Type A211 to 250 Units of Botulinum Toxin Type A
Baseline1.92 ± 0.672.07 ± 0.532.20 ± 0.66
Week 40.54 ± 0.580.59 ± 0.500.57 ± 0.50
Week 161.25 ± 0.601.12 ± 0.601.07 ± 0.54
Week 201.42 ± 0.651.44 ± 0.581.31 ± 0.71
Week 241.65 ± 0.691.66 ± 0.481.53 ± 0.63
Statistical analysis
  • 125 to 170 Units of Botulinum Toxin Type A vs 171 to 210 Units of Botulinum Toxin Type A vs 211 to 250 Units of Botulinum Toxin Type A · GLM · p = <0.05 (P-value threshold for significance: \<0.05)
PrimaryWrinkles' Severity (Periocular [Crow's Feet])

Photonumeric Atlas for the Assessment of Crow's Feet Severity: 0 - none, 1 - mild; 2 - moderate; 3 - severe

Time frame:
Baseline; Week 4; Week 16; Week 20; Week 24
Reported as:
Mean · units on a scale
Wrinkles' Severity (Periocular [Crow's Feet])
units on a scale125 to 170 Units of Botulinum Toxin Type A171 to 210 Units of Botulinum Toxin Type A211 to 250 Units of Botulinum Toxin Type A
Baseline2.04 ± 0.722.41 ± 0.572.17 ± 0.79
Week 41.04 ± 0.661.21 ± 0.561.27 ± 0.45
Week 161.54 ± 0.591.92 ± 0.491.86 ± 0.71
Week 201.67 ± 0.702.12 ± 0.442.10 ± 0.41
Week 241.88 ± 0.592.10 ± 0.412.33 ± 0.55

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
125 to 170 Units of Botulinum Toxin Type A—0/26 (0%)0/26 (0%)
171 to 210 Units of Botulinum Toxin Type A—0/29 (0%)0/29 (0%)
211 to 250 Units of Botulinum Toxin Type A—0/30 (0%)0/30 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Group 1Group 2Group 3Total
<=18 years0000
Between 18 and 65 years30303090
>=65 years0000
Age, Continuous
Age, Continuous(years)Group 1Group 2Group 3Total
Mean46 ± 947 ± 950 ± 948 ± 7
Sex: Female, Male
Sex: Female, Male(Participants)Group 1Group 2Group 3Total
Female30303090
Male0000
Region of Enrollment
Region of Enrollment(participants)Group 1Group 2Group 3Total
Brazil30303090
08

Study locations

1 site
  • Brazilian Center for Studies in Dermatology
    Porto Alegre, Rio Grande Do Sul 90570-040, Brazil
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01032954
Lead sponsor
Brazilan Center for Studies in Dermatology
Responsible party
Doris Hexsel (MD, Brazilan Center for Studies in Dermatology) — Principal investigator
First posted
Dec 16, 2009
Start date
Nov 2009
Primary completion
Dec 2010
Completion
Dec 2010
Results posted
Sep 17, 2020
Last update
Oct 14, 2020

Study contacts

Doris M Hexsel, MD
principal investigator · Brazilian Center for Studies in Dermatology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Brazilan Center for Studies in Dermatology

Start the discussion