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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called DAXXIFY (DaxibotulinumtoxinA-lanm) to determine its effectiveness and safety in reducing frown and forehead lines. The goal is to help individuals with moderate to severe lines in these areas achieve smoother skin. Participants will receive a DAXXIFY injection and undergo monitoring for results. This trial may suit those with noticeable frown and forehead lines during facial expressions who have not received botulinum toxin treatments on their face in the last six months. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that DAXXIFY is likely to be safe for humans?

Research has shown that DAXXIFY, a treatment for frown lines, is generally well-tolerated. One study found that patients experienced good results and longer-lasting effects when using DAXXIFY for lines on the upper face. Importantly, after the product became available on the market, the safety data analysis revealed no new safety concerns.

However, potential side effects should be considered. Reports have indicated serious issues like trouble swallowing and breathing, which can be life-threatening. Although these effects are rare, they should be considered when deciding to join a trial. Overall, the FDA has approved DAXXIFY for treating lines between the eyebrows, suggesting it is safe for this use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for frown lines, like Botox and Dysport, work by temporarily paralyzing the muscles that cause wrinkles. DaxibotulinumtoxinA-lanm, or DAXXIFY, is unique because it uses a novel peptide technology that might extend the duration of its effects. This could mean longer-lasting results, reducing the need for frequent touch-ups. Researchers are excited about DAXXIFY because it has the potential to offer patients a more convenient option with fewer injections over time.

What evidence suggests that DAXXIFY might be an effective treatment for frown lines?

Research has shown that DAXXIFY, the treatment under study in this trial, effectively reduces frown lines, particularly those between the eyebrows. Studies found that about 74% of patients noticed improvements in their lines after four weeks. The treatment typically keeps lines mild or absent for about 24 weeks. It outperforms a placebo and offers long-lasting results. These findings suggest that DAXXIFY could be a promising option for treating forehead and eyebrow lines. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

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

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

I am allergic to botulinum toxin or its ingredients.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9760460/

Treatment of Upper Facial Lines With DaxibotulinumtoxinA ... Simultaneous treatment of upper facial lines with DAXI was well tolerated and demonstrated high response rates, extended duration, and high patient ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0190962219324594

DaxibotulinumtoxinA for Injection has a prolonged duration ... DAXI was significantly more effective than placebo in reducing glabellar line severity and maintained none or mild glabellar line severity for a median of 24.0 ...

3. hcp.daxxify.com hcp.daxxify.com/

Peptide-powered, FDA-approved Glabellar Lines Treatment ... 74% of patients in clinical studies had improvement at week 4 per both physician's and patient's assessments. At least 50% of patients in SAKURA 1 and SAKURA 2 ...

4. fda.gov fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-daxxify

Drug Trials Snapshot: DAXXIFY In two trials, patients with moderate to severe wrinkles between the eyebrows had improvement of frown lines four weeks after treatment with ...

5. academic.oup.com academic.oup.com/asj/article/43/2/205/6695383

Efficacy and Safety of DaxibotulinumtoxinA for Injection in the ... Rates of achieving none or mild glabellar lines with DAXI were high, regardless of age and race, and the duration of response was consistent across all ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/761127s000lbl.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION These ... moderate to severe frown lines between the eyebrows (glabellar lines). It is not known if DAXXIFY is safe and effective in children less than 18 years of age.

7. daxxify.com daxxify.com/

Long-lasting Frown Line Treatment - DAXXIFY® 74% achieved a ≥ 2-grade improvement at week 4 per both physician's and patient's assessment. More than 50% had no or minor frown lines until 6 months after ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2022/761127Orig1s000MultidisciplineR.pdf

761127Orig1s000 - accessdata.fda.gov Expectations on Safety in the Postmarket Setting. The comprehensive analysis of the safety data for DAXXIFY identified no new safety signals.