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Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study III (BLESSIII)

NCT03985982 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2025-06-05

Study results available
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Summary

The aim of this study is to assess the efficacy and safety of BoNT/A-DP in the treatment of glabellar lines in comparison with placebo, including efficacy after repeat treatments and long term safety.

Conditions

  • Glabellar Frown Lines

Interventions

DRUG

Botulinum Toxin A

Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area

DRUG

Placebo

injection, sodium chloride 0.9 % divided in five 0.1 mL i.m injections into the glabellar area

DRUG

Botulinum Toxin A

Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area in up to 3 treatment cycles

Sponsors & Collaborators

  • Croma-Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Jeffrey Adelglass, Dr. · SKINTASTIC Medical

  • Sue Ellen Cox, Dr. · Aesthetic Solutions P.A.

  • Michael Gold, Dr. · Tennessee Clinical Research Center

  • Joely Kaufman-Janette, Dr. · Skin Research Institute LLC

  • Susan Taylor, Dr. · Perelman Center for Advanced Medicine-University of Pennsylvania

  • Mark Nestor, Dr. · Center for Clinical and Cosmetic Research

  • Daniel Mueller, Dr. · Yuvell (Austria)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-29
Primary Completion
2019-12-04
Completion
2020-12-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03985982 on ClinicalTrials.gov