Phase 4
Completed N=90
Safety and Efficacy of the Full Face Applications of Variable Doses of a Commercial Botulinum Toxin Type a (Dysport®)
Sun-induced Wrinkles
Source: ClinicalTrials.gov NCT01032954 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Wrinkles' Severity (Forehead) — 2.31; 2.66; 2.60; 1.78 units on a scale — p=<0.05
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wrinkles' Severity (Forehead) |
2.31; 2.66; 2.60; 1.78; 1.33; 0.93 | <0.05 sig |
| PRIMARY Wrinkles' Severity (Glabella) |
1.92; 2.07; 2.20; 0.54; 0.59; 0.57 | <0.05 sig |
| PRIMARY Wrinkles' Severity (Periocular [Crow's Feet]) |
2.04; 2.41; 2.17; 1.04; 1.21; 1.27 | — |
Eligibility Criteria
Inclusion Criteria
- Written Informed Consent;
- Subjects aged between 30 and 60 years;
- Skin Fitzpatrick Phototypes I to VI;
- 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;
- Subjects presenting at least two indications for treatment with BT-A in each third of the face;
- 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;
- 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);
- Availability of the patient throughout the duration of the study (24 weeks);
- Subjects that agree not to undergo other cosmetic or dermatological procedures during the study;
- Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by the study protocol.
Exclusion Criteria
- Pregnant women or women intending to become pregnant during the study;
- Subjects participating in other clinical trials;
- Presence of scars on the face that may interfere with the result of study;
- Subjects with neoplastic, muscular or neurological diseases;
- Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics.
- Subjects with inflammation or active infection in the face;
- Subjects with a history of sensitivity to the components of the formula;
- Subjects with prior history of eyelid ptosis; marked facial asymmetry, excessive dermatochalasis, deep dermal scarring or thick sebaceous skin.
- Subjects presenting myasthenia gravis, Eaton-Lambert Syndrome and motor neuron diseases;
- Subjects with coagulation disorders or using anticoagulants;
- Subjects with known systemic autoimmune diseases;
- 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;
- Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol.
Data sourced from ClinicalTrials.gov (NCT01032954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.