A Phase 3 interventional study of Botulinum Toxin A in Skin Aging, sponsored by Biolab Sanus Farmaceutica. Completed at 1 site in Brazil. Open to female participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-11.
Sponsored by Biolab Sanus Farmaceutica · Phase 3, Interventional, and Treatment
The purpose of this study is to determinate whether Xeomin® (Botulinum toxin Type A) is safe, effective and tolerable in woman aged 30 to 50 years old for treatment of mild, moderate or severe expression lines (wrinkles) in the upper third of the face. The main outcome was the change in appearance of the wrinkles two weeks (visit 3) after product application as compared with baseline assessment.
Ageing is a dynamic and unchangeable process involving all individuals and affecting the several organic systems. This process is expressed through multiple symptoms and signs, the wrinkles and flaccidity being the most common and visible ones.
In both developed and emerging countries, the interest in skin ageing is, to a greater extent, the result of the progressive increase in the absolute number and the proportion of people experiencing the ageing process in the last century. The psychosocial, as well as the physiological effects of the skin ageing raised a huge demand for a better understanding of this process and, in particular, of the effective interventions.
The use of the botulinum toxin type-A (BTX/A) for aesthetic indication emerged as a result of the clinical observation of those patients treated for facial different dystonia and who presented additional improvement of their expression lines.
The expression lines are most easily noted on the upper third of the face, where surgical treatments are fully invasive and show lesser noticeable results. The upper third of the face was targeted for BTX/A treatment and reported in several scientific literature articles as well succeeded.
Biolab Sanus Farmaceutica is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Botulinum Toxin A
Biological: Botulinum Toxin A
100 U DL50 lyophilized powder for reconstitution in 1 ml Saline Solution 0.9%.
Also known as: Xeomin®
Treatment Success
Success has been defined as the reduction of any grade to a lower grade of expression wrinkles in the visit 3 (day 15) compared to the baseline assessment. The wrinkles will be classified according to the following: absence, mild, moderate, severe.
Time frame: Baseline (pre-treatment) and Visit 3 (Day 15)
Date of recruitment : 01-Sep-2009 to 09-Feb-2010 Location: Outpatient clinic; Cosmiatry, surgery and oncology unit, Department of Dermatology, UNIFESP, Sao Paulo, Brazil
| Milestone | Xeomin® |
|---|---|
| Started | 121 |
| Completed | 114 |
| Not completed | 7 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Potential bias for objective assessment | 1 |
Success has been defined as the reduction of any grade to a lower grade of expression wrinkles in the visit 3 (day 15) compared to the baseline assessment. The wrinkles will be classified according to the following: absence, mild, moderate, severe.
| % of participants | Xeomin® |
|---|---|
| Treatment Success | 89.08 (83.48 to 94.68) |
Non-serious events are listed at a 0.5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Xeomin® | — | 1/121 (0.8%) | 94/121 (77.7%) |
| Event | Xeomin® |
|---|---|
| Acute gastroenteritisGastrointestinal disorders | 1/121 |
| Event | Xeomin® |
|---|---|
| Injection-site bleedingSurgical and medical procedures | 39/121 |
| HeadacheNervous system disorders | 25/121 |
| Injection-site painSurgical and medical procedures | 9/121 |
| DeformitySurgical and medical procedures | 6/121 |
| Injection-site pruritusSurgical and medical procedures | 4/121 |
| Eyelid edemaSkin and subcutaneous tissue disorders | 2/121 |
| Worsening of baseline wrinklesSkin and subcutaneous tissue disorders | 2/121 |
| NauseaGastrointestinal disorders | 2/121 |
| Site-injection edemaSurgical and medical procedures | 1/121 |
| Sore throatInfections and infestations | 1/121 |
| Age, Customized(participants) | Xeomin® |
|---|---|
| Between 30 and 50 years | 121 |
| Age, Continuous(years) | Xeomin® |
|---|---|
| Mean | 42.52 ± 0.42 |
| Sex: Female, Male(Participants) | Xeomin® |
|---|---|
| Female | 121 |
| Male | 0 |
| Region of Enrollment(participants) | Xeomin® |
|---|---|
| Brazil | 121 |
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Biolab Sanus Farmaceutica