A prospective, multicenter, randomized, rater- and subject-blind, parallel group trial to investigate the non-inferiority of NT 201, free of complexing proteins, in comparison with Clostridium botulinum toxin type A in the treatment of glabellar frown line - NT-H2H

Merz Pharmaceuticals GmbH0 sites384 target enrollmentJanuary 7, 2009

Overview

No summary available.

Registry

who.int

Start Date

January 7, 2009

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•\- Female with moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on FWS) as assessed by the investigator’s rating
•\- Age between 18 and 50 (inclusively)
•\- Willing and able to complete the entire course of the trial and to comply with trial instructions
•\- Written informed consent
•\- For females of childbearing potential (last menses less than one year prior to enrolment): negative pregnancy test at screening and at baseline (i.e. prior to entry in the double\-blind treatment phase); not breast\-feeding; either surgically sterile or agreement to use a medically accepted, highly effective contraception during the entire duration of the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner (def. see protocol)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

•\- Severe glabellar frown lines at rest, according to investigator’s rating on FWS
•\- Previous treatment with Botulinum neurotoxin of any serotype in the upper third part of the face within the last 6 months, e.g., treatment of glabellar area, forehead lines, crow’s feet, bunny lines, eyebrow lifting
•\- Previous treatment with biodegradable fillers in the glabellar area within the last 12 months
•\- Previous insertion of permanent material in the glabellar area, including fat graft
•\- Previous treatment with any facial cosmetic procedure photo in the glabellar area within the last 6 months
•\- Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these
•\- Any scars in the glabellar are
•\- Any other planned cosmetic procedure in the upper third part of the face during the trial period
•\- Marked facial asymmetry
•\- Ptosis of eyelid and/or eyebrow