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Effectiveness and durability of ready-to-use botulinum toxin A formulations (Relfydess and Alluzience) for treating moderate to severe frown lines: a randomized controlled clinical trial

Efficacy and durability of liquid formulations of botulinum toxin type A, Relabotulinumtoxin-A (Relfydess) and RTU Abobotulinumtoxin-A (Alluzience), in the treatment of moderate-to-severe dynamic glabellar lines: a randomized, controlled, triple-blind clinical study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-10tkjh3t
Enrollment
40
Registered
2026-04-26
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Muscles Skin Aging

Interventions

This study is designed as a randomized, controlled, two-arm, triple-blind clinical trial, in which participants, the injector, and the outcome assessor are all blinded to group allocation. A total of
Alluzience), while the comparator group (G2) will receive a single administration of relabotulinumtoxinA (Relfydess), both injected into the glabellar region. All procedures will be performed under st

Sponsors

Centro Universitário Uningá
Lead Sponsor
Egas Moniz School of Health and Science
Collaborator

Eligibility

Sex/Gender
Female
Age
25 Years to 50 Years

Inclusion criteria

Inclusion criteria: female patients aged between 25 and 50 years; presence of dynamic glabellar lines involving the procerus and corrugator muscles; no botulinum toxin injections within the last year for aesthetic or therapeutic purposes in any body region; moderate to severe glabellar lines according to the 5-point Merz scale; and no aesthetic procedures performed in the upper third of the face within the last year. 3. Moderate to severe glabellar lines according to the 5-point Merz scale; 4. No other aesthetic procedures performed in the upper third of the face within the last year.

Exclusion criteria

Exclusion criteria: receipt of tetanus or COVID-19 vaccination within the last three months prior to study initiation; presence of autoimmune diseases; pregnancy or breastfeeding; presence of neuromuscular disorders, such as myasthenia gravis or Lambert–Eaton syndrome; current use of medications affecting neuromuscular junctions; engagement in high-intensity physical exercise; and refusal or inability to sign the Informed Consent Form

Design outcomes

Primary

MeasureTime frame
It is expected that the efficacy and durability of RTU relabotulinumtoxin-A (Relfydess) will be superior to RTU abobotulinumtoxin-A (Alluzience) in improving the severity of glabellar lines

Secondary

MeasureTime frame
No secondary outcomes are expected

Countries

BR

Contacts

Public ContactLucas Sousa Mendes

Centro Universitário Uningá

drlucassousamendes.cd@outlook.com47999551238

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: May 1, 2026