DAXXIFY for Frown Lines

Overseen By Jessica Brown

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Revance Therapeutics, Inc.

Must not be taking: Botulinum toxin

Disqualifiers: Pregnancy, Allergy to botulinum, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

27 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 2a open-label, single-arm study to evaluate the effects of DaxibotulinumtoxinA-lanm (DAXI) for Injection on the treatment of dynamic forehead lines (FHL) and glabellar lines (GL). Approximately 40 subjects (18 years of age and above) with moderate to severe GL and FHL (all assessed at maximum contraction) will be screened for eligibility with the goal of enrolling and treating 30 subjects to receive DAXI for injection after providing informed consent. The primary objective of this study is to determine the efficacy and safety of the combined treatment of two upper facial regions with DAXI for injection.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have used botulinum toxin treatments in the past 6 months, you may not be eligible to participate.

How is the drug DAXXIFY different from other treatments for frown lines?

DAXXIFY is unique because it is a new formulation of botulinum toxin type A that lasts longer than traditional treatments like Botox, with effects lasting up to 24 weeks. It also has a low potential for causing unwanted immune responses, making it a reliable option for reducing wrinkles. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults over 18 with moderate to severe frown lines and forehead wrinkles, visible at maximum contraction. Participants should be in good general health and able to visit the clinic as outpatients.

Inclusion Criteria

Have a score of moderate (2) or severe (3) GL during maximum contraction as assessed by the IGA-FWS

Have a score of moderate (2) or severe (3) FHL during maximum contraction as assessed by the IGA-FHWS

Exclusion Criteria

I haven't had Botox in my face or more than 200 units elsewhere in the last 6 months.

Pregnant, nursing, or planning a pregnancy during the study; or is a WOCBP but is not willing to use an effective method of contraception

I am allergic to botulinum toxin or its ingredients.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DaxibotulinumtoxinA-lanm (DAXI) for injection for the treatment of dynamic forehead lines and glabellar lines

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DaxibotulinumtoxinA-lanm

Trial Overview The study tests DaxibotulinumtoxinA-lanm (DAXI) injections on two facial areas: the forehead and between the eyebrows. It's an open-label, single-arm Phase 2a trial aiming to enroll about 30 subjects to assess efficacy and safety.

Participant Groups

Group I: Active Treatment (DAXXIFY) Experimental Treatment 1 Intervention

All subjects will receive DAXXIFY for injection as IM injections.

DaxibotulinumtoxinA-lanm is already approved in United States for the following indications:

Approved in United States as Daxxify for:

• Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients
• Treatment of cervical dystonia in adult patients

Who Is Running the Clinical Trial?

Revance Therapeutics, Inc.

Lead Sponsor

Trials

32

Recruited

6,600+

Findings from Research

DaxibotulinumtoxinA (DAXI) 40 U effectively reduced glabellar line severity in over 96% of patients across various age and race subgroups, with results maintained for a median of 24 weeks after treatment.

The safety profile of DAXI was consistent across all demographic groups, with treatment-emergent adverse events being similar, indicating it is a safe option for diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of DaxibotulinumtoxinA for Injection in the Treatment of Glabellar Lines by Age and Race: Subgroup Analysis of the SAKURA Clinical Trials. Solish, N., Burgess, CM., Weinkle, SH., et al.[2023]

DaxibotulinumtoxinA (DAXI) has been approved by the FDA for treating glabellar frown lines, offering a longer-lasting alternative to traditional Botox treatments, which typically require injections every 12-16 weeks.

Clinical trials (SAKURA 1, 2, and 3) suggest that DAXI may reduce the frequency of required treatments, making it a promising and safe option for both cosmetic and therapeutic applications in wrinkle reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DAXI (DaxibotulinumtoxinA) - An Innovative Approach for Frown Lines. Mussarat, A., Mustafa, MS., Azam, ST., et al.[2023]

In a study involving 2737 patients, DaxibotulinumtoxinA-lanm (DAXI) showed a low immunogenic potential, with only 0.8% developing treatment-related nonneutralizing antibodies, which did not affect clinical efficacy.

Patients who developed transient binding antibodies still achieved a clinical response with no significant difference in treatment duration compared to those without antibodies, indicating that DAXI remains effective even in the presence of these antibodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity of DaxibotulinumtoxinA for Injection in Glabellar Lines. Humphrey, S., Dover, JS., Bowsher, RR., et al.[2023]

In a study involving 568 adults with moderate to severe dynamic glabellar lines, repeated treatments with DaxibotulinumtoxinA (DAXI) led to a significant increase in the number of subjects showing no static glabellar lines, with improvements observed after each treatment cycle.

The results suggest that DAXI not only effectively reduces dynamic glabellar lines but also promotes long-term benefits through muscle inactivity, allowing for dermal remodeling over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive Improvement in Static Glabellar Lines After Repeated Treatment With DaxibotulinumtoxinA for Injection. Glogau, R., Kontis, TC., Liu, Y., et al.[2023]

In two phase 3 studies involving 609 subjects, DaxibotulinumtoxinA (DAXI) demonstrated significant efficacy in reducing glabellar line severity compared to placebo, with 73.6% and 74.0% of subjects showing at least a 2-point improvement at week 4.

DAXI provided a prolonged duration of effect, maintaining reduced glabellar line severity for a median of 24 weeks, and was generally well tolerated, with common side effects being mild headaches and injection-site pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2). Carruthers, JD., Fagien, S., Joseph, JH., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of DaxibotulinumtoxinA for Injection in the Treatment of Glabellar Lines by Age and Race: Subgroup Analysis of the SAKURA Clinical Trials. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

DAXI (DaxibotulinumtoxinA) - An Innovative Approach for Frown Lines. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Immunogenicity of DaxibotulinumtoxinA for Injection in Glabellar Lines. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Progressive Improvement in Static Glabellar Lines After Repeated Treatment With DaxibotulinumtoxinA for Injection. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2). [2022]