Safety and efficacy study of the simultaneous treatment of upper facial lines (horizontal forehead lines, glabellar frown lines and crows feet) in subjects with moderate to severe upper facial lines.

Phase 1

• Conditions: Moderate to severe upper facial lines(horizontal forehead lines, glabellar frown lines, and lateral canthal lines); MedDRA version: 20.0Level: LLTClassification code 10048042Term: WrinklesSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 21.1Level: LLTClassification code 10052609Term: Glabellar frown linesSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 20.0Level: LLTClassification code 10052611Term: Crow's feetSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 21.1Level: PTClassification code 10040954Term: Skin wrinklingSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 20.0Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2019-004113-13-DE
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-30
• Study Completion: 2022-07-08
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 368

Inclusion Criteria

• Outpatients (male or female) 18 years of age or older.

• HFL, GFL, and symmetrical LCL of moderate (score 2) to severe (score 3) intensity at maximum contraction as assessed by the investigator and subject according to the Merz Aesthetics Scales. The rating of the investigator and the subject do not have to coincide as long as they are moderate or severe.
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 340
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• Previous treatment with botulinum neurotoxin [BoNT] of any serotype in the face within the last 12 months before injection

• Any facial cosmetic procedure within the last 12 months before baseline injection, such as dermal filling, chemical peeling, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, ultrasound treatment, tattooing of eyebrows.

• Previous treatment with any biodegradable filler in the face within the last 12 months before injection.

• Any previous insertion of permanent material in the face including any insertion of treads in the upper face or at cheeks (regardless of the time between previous treatment and this study).

• Any medical condition that may put the subject at increased risk with exposure to NT 201, including myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified