NCT01180348 is a Phase 3 clinical trial of Botulift in Wrinkles, sponsored by Azidus Brasil.

Who is sponsoring NCT01180348?

NCT01180348 is sponsored by Azidus Brasil.

What drugs are being tested in NCT01180348?

Interventions in NCT01180348: Botulift, Botox.

Is NCT01180348 still recruiting?

NCT01180348 is currently completed. Last updated 3 March 2016.

Last reviewed 2016-03-03 · How we verify

NCT01180348

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Randomized Study of Clinical Non-inferiority of Medicine Botulift (Laboratório Químico Farmacêutico Bergamo Ltd.) Compared to Botox ® (Allergan Inc.) in the Improvement of Wrinkles in the Facial Region.

Completed Phase 3 Last updated 3 March 2016

What this trial tests

Phase 3 trial testing Botulift in Wrinkles in 192 participants. Completed in 1 September 2012.

Timeline

1 August 2011

Primary endpoint
1 October 2011

1 September 2012

Quick facts

Lead sponsor	Azidus Brasil
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	192
Start date	1 August 2011
Primary completion	1 October 2011
Estimated completion	1 September 2012
Sites	1 location across Brazil

Drugs / interventions tested

Botulift — full drug profile →
Botox (ONABOTULINUMTOXINA) — full drug profile →

Conditions studied

Wrinkles — all drugs for Wrinkles →

Sponsor

Azidus Brasil — full company profile →

Who can join

Adults 18 to 65, female only, with Wrinkles. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

overall improved assessment of hyperkinetic facial lines in a state of relaxation and maximal contraction through the Honeck's scale and photographic images obtained by equipment Visia Digital Compexton Analysis (Canfield Imaging Systems, version 4.0.2)
Time frame: after 30 days of application
The non-inferiority of T group compared to the group Co was demonstrated in evaluations in a state of relaxation and maximal contraction in the PP analysis population, because as defined for the study, the lower limits of 95% of the mean of these assessments (-2 , 7% and -5.4%) are contained within the non-inferiority limit set at -10%.

Sponsor's own description

The dermatological treatment for reducing facial wrinkles with injectable drug Botulift (botulinum toxin type A - Laboratório Químico Farmacêutico BergamoLtd.) has a not inferior activity when compared with Botox ® (botulinum toxin - Allergan Inc.) in clinical trials.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Botulinum toxin type A for facial wrinkles.
Camargo CP, Xia J, Costa CS, Gemperli R, et al · · 2021 · cited 21× · PMID 34224576 · DOI 10.1002/14651858.cd011301.pub2

Verify or expand the search:

Other recruiting trials for Wrinkles

Currently open trials in the same condition.

NCT07495865 — Post-market Clinical Follow-up (PMCF) Study of Safety and Performance of 502-01 AnGelHA 2 · recruiting
NCT07111156 — A Clinical Study to Test the Safety and Effectiveness of Pinorox® for Improving Visible Signs of Facial Aging Such as Wr · NA · active not recruiting
NCT06724510 — Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting · NA · recruiting

Other Azidus Brasil trials

Trials by the same sponsor.

NCT06303635 — Safety of UFRJvac, Trivalent COVID-19 Vaccine · unknown
NCT06097780 — Efficacy and Safety of NestaCell® in Huntington's Disease · Phase 3 · unknown
NCT06150833 — Efficacy and Safety and Pharmacokinetics of Boya IVIG · Phase 3 · unknown
NCT05603403 — Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms · Phase 4 · completed
NCT05009277 — Study To Evaluate The Sensitivity Of The Linda Thermal Device · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01180348 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Azidus Brasil
Last refreshed: 3 March 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01180348.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing