New Anesthetic Agent for Pain in Aesthetic Treatments

Not currently recruiting at 2 trial locations

Overseen By Elise GONDARD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Teoxane SA

Must not be taking: Local anesthetics

Disqualifiers: Pregnancy, Active skin disease, Malignancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new anesthetic agent to determine if it reduces pain as effectively as lidocaine during cosmetic injections around the mouth. Participants will receive two different treatments on each side of their mouth, enabling researchers to compare pain levels between the new anesthetic and lidocaine. The study seeks individuals with similar wrinkles around their mouth on both sides who can attend all study visits. Participants may experience less pain during cosmetic procedures and contribute to advances in aesthetic treatments.

As an unphased trial, this study allows participants to directly contribute to the development of innovative anesthetic solutions in cosmetic medicine.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that RHA® Redensity is generally safe and effective for smoothing facial lines. Many studies have examined its safety and efficacy. One study found that RHA® Redensity, when combined with a new numbing agent, safely treated facial wrinkles without causing unexpected side effects.

In another study, patients reported that the treatment effectively reduced facial wrinkles, with no serious unwanted side effects. These findings suggest that the new numbing agent in RHA® Redensity is well-tolerated.

RHA® Redensity with lidocaine, a well-known numbing agent, is also used in similar treatments and has a strong safety record. It is often used to reduce pain during injections.

Overall, the available evidence supports the safety of both RHA® Redensity with the new numbing agent and RHA® Redensity with lidocaine, which should reassure those considering participating in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they involve a new anesthetic agent used in aesthetic procedures for reducing perioral wrinkles, which are those around the mouth. Unlike the typical lidocaine, this new anesthetic promises potentially improved pain management or fewer side effects. What makes this approach stand out is the direct comparison between RHA® Redensity with the new anesthetic and the same product with lidocaine, providing a clear view of the new agent's benefits. If successful, this could mean more comfortable and effective treatments for anyone looking to reduce signs of aging with dermal fillers.

What evidence suggests that this trial's treatments could be effective for reducing pain during aesthetic injections?

This trial will compare RHA® Redensity with a new anesthetic agent to RHA® Redensity with lidocaine for pain management in aesthetic treatments. Research has shown that RHA® Redensity with the new numbing agent effectively reduces pain during beauty treatments. Studies have found that this new numbing agent can manage discomfort, making the procedure more comfortable. RHA® Redensity has been proven safe and effective for treating lines around the mouth, with lasting results. Similarly, RHA® Redensity with lidocaine is already known to work well for the same purpose. Both treatments in this trial aim to improve the appearance of these lines while also providing pain relief during the procedure. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with visible signs of aging around the mouth, assessed by a specific scale. Participants must be eligible based on their perioral rhytid severity and willing to receive injections on both sides of their mouth with different anesthetics.

Inclusion Criteria

Sign the IRB-approved ICF, Photographic Release Form, the Authorization for Use and release of Health and Research Study Information (HIPAA) form, and if applicable the California Experimental Research Subject's Bill of Rights prior to any study-related procedures being performed

I am a woman who can have children, have a negative pregnancy test, and use birth control during the study.

I am 22 years old or older and can visit the clinic for treatment.

Exclusion Criteria

I am pregnant, breastfeeding, or could become pregnant and am not using reliable birth control.

I haven't had any significant facial procedures that could affect study results.

I have not had cancer (other than non-melanoma skin cancer) in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

RHA® Redensity with new anesthetic agent and RHA® Redensity with lidocaine are administered in a split-face manner to assess injection site pain

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including AE assessments and a follow-up call at 72 hours post-injection

30 days

1 visit (in-person), 1 call (virtual)

Optional Follow-up

Participants with unresolved clinically significant device-related AEs receive an optional follow-up call and may attend an in-clinic visit if necessary

Up to 30 days after Visit 2

What Are the Treatments Tested in This Trial?

Interventions

• RHA® Redensity with lidocaine
• RHA® Redensity with new anesthetic agent

Trial Overview

The study compares RHA® Redensity filler combined with a new anesthetic versus the same filler with lidocaine, focusing on pain during injection. It's randomized and double-blinded, meaning neither participants nor injectors know which treatment is given first or to which side of the mouth.

How Is the Trial Designed?

Group I: RHA® Redensity with new anesthetic agent Experimental Treatment 1 Intervention

Split-face injection of RHA® Redensity with new anesthetic agent in the perioral rhytids on one side of the mouth and RHA® Redensity with lidocaine in the perioral rhytids in the other side of the mouth. Up to 3 mL injected per side.

Group II: RHA® Redensity with lidocaine Experimental Treatment 1 Intervention

Split-face injection of RHA® Redensity with new anesthetic agent in the perioral rhytids on one side of the mouth and RHA® Redensity with lidocaine in the perioral rhytids in the other side of the mouth. Up to 3 mL injected per side.

Who Is Running the Clinical Trial?

Teoxane SA

Lead Sponsor

Trials

14

Recruited

1,700+

Published Research Related to This Trial

In a study involving 60 patients with moderate to severe nasolabial folds, the hyaluronic acid filler containing 0.3% lidocaine significantly reduced pain during and after injection compared to a non-lidocaine filler, indicating enhanced patient comfort.

Long-term follow-up (up to 76 weeks) showed that the inclusion of lidocaine did not affect the longevity of the filler, with 91% of patients showing no facial asymmetry and requiring only minor 'top-up' treatments, suggesting sustained effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longevity of effects of hyaluronic acid plus lidocaine facial filler. Raspaldo, H., De Boulle, K., Levy, PM.[2013]

Lidocaine hydrochloride is the most commonly used anesthetic in dermatology, and adverse reactions are very rare, primarily consisting of vasovagal responses and local effects like bruising and swelling.

This report highlights an extremely rare case of a true type I hypersensitivity allergy to lidocaine, which is believed to account for only 1% of all adverse reactions to this anesthetic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case reports: type I hypersensitivity to lidocaine. Haugen, RN., Brown, CW.[2013]

Local anaesthetic agents are generally safe, but adverse reactions can occur, and these are often misdiagnosed as hypersensitivity reactions by practitioners.

Mislabeling patients as allergic to local anaesthetics can prevent them from receiving necessary dental treatments, highlighting the importance of correctly identifying and managing adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An adverse reaction to local anaesthesia: report of a case. Selcuk, E., Ertürk, S., Afrashi, A.[2013]

Articaine (4% with epinephrine 1:100,000) is shown to be an effective local anesthetic for pediatric patients, providing lower pain ratings during dental procedures compared to lidocaine (2% with epinephrine 1:100,000), with Visual Analog Scale scores indicating less pain for both simple and complex procedures.

The study found no serious adverse events related to articaine, confirming its safety in children, with only a minor incident of accidental lip injury reported, suggesting that articaine is a safe option for local anesthesia in pediatric dentistry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison between articaine HCl and lidocaine HCl in pediatric dental patients. Malamed, SF., Gagnon, S., Leblanc, D.[2022]

Local anesthetics are generally safe and adverse events are rare, allowing for their frequent use in medical and dental procedures.

Despite their safety, complications can still occur with local anesthetic administration, and while practitioners can take steps to prevent them, not all complications can be avoided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Localized complications from local anesthesia. Haas, DA.[2005]

In a study involving 102 subjects, the new formulation of calcium hydroxylapatite microspheres with 0.3% lidocaine (CaHA (+)) significantly reduced pain during injection compared to the standard CaHA, with a mean difference in pain ratings of -4.41 on a 10-cm scale (P<0.0001).

Both CaHA formulations provided significant aesthetic improvements, but the reduced pain associated with CaHA (+) led to a strong preference among 90% of subjects for this formulation, indicating its potential for enhanced patient comfort during cosmetic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium Hydroxylapatite With Integral Lidocaine Provides Improved Pain Control for the Correction of Nasolabial Folds. Schachter, D., Bertucci, V., Solish, N.[2017]

In a study involving 29 women aged 30-85, a lidocaine-containing dermal filler significantly reduced pain during and after treatment compared to a lidocaine-free filler, with 86% of practitioners noting less pain for their patients.

Both fillers were reported to have similar administration experiences and aesthetic outcomes, indicating that the addition of lidocaine improves patient comfort without compromising the effectiveness or safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, comparative survey to investigate practitioners' satisfaction with a cohesive, polydensified-matrix(®) , hyaluronic acid-based filler gel with and without lidocaine for the treatment of facial wrinkles. Prager, W., Micheels, P.[2015]

Lidocaine/tetracaine cream (Pliaglis) is a newer topical anesthetic that effectively reduces pain during cosmetic dermatologic procedures, as shown in multiple clinical trials.

This combination anesthetic is favored for its ease of use and mild side effects compared to other topical anesthetics, making it a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of lidocaine/tetracaine cream as a topical anesthetic for dermatologic laser procedures. Alster, T.[2021]

A clinical follow-up study involving 84 patients across 11 centers over 6-8 months aimed to evaluate the benefits of adding lidocaine to the Stylage® filler, which also contains mannitol as an antioxidant.

The study sought to clarify whether the inclusion of lidocaine provides significant advantages in pain relief during injection, affects the safety profile, or influences the longevity of the filler results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of adding lidocaine to a hyaluronic gel - Stylage® M. Mole, B., Gozlan, L.[2013]

In a study of 183 patients, 4 individuals tested positive for delayed-type hypersensitivity to lidocaine, suggesting that such reactions may be more common than previously recognized.

For patients suspected of having a type IV hypersensitivity to lidocaine, it is recommended to conduct patch testing followed by intradermal challenges to confirm sensitivity and explore alternative anesthetic options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed-type hypersensitivity to lidocaine. Mackley, CL., Marks, JG., Anderson, BE.[2019]

The injection of local anesthetics is often the most painful part of outpatient skin procedures, influenced by factors such as needle size, injection technique, and the physician's approach.

The article discusses various techniques to minimize pain during local anesthetic administration, highlighting the importance of optimizing these factors for patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten commandments for minimal pain during administration of local anesthetics. Zilinsky, I., Bar-Meir, E., Zaslansky, R., et al.[2005]

A new method of injecting calcium hydroxylapatite (CaHA) for hand treatment combines the filler with anesthetic, making the procedure significantly less painful compared to traditional methods.

This innovative approach not only reduces pain but also leads to less swelling and bruising, allowing for quicker recovery and minimal downtime for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand augmentation with Radiesse (Calcium hydroxylapatite). Busso, M., Applebaum, D.[2013]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04069585

RHA® Redensity With New Anesthetic Agent - Perioral Rhytids

Subject's Perception of Treatment Effectiveness as Per the FACE-Q (Perioral Rhytids Domain) Questionnaire. The FACE-Q measures the experience and outcomes ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8667798/

Efficacy and Safety of a New Resilient Hyaluronic Acid ...

Resilient Hyaluronic Acid Redensity is effective and safe for the correction of dynamic perioral rhytides in all Fitzpatrick phototypes, with marked durability.

3.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf17/P170002S026B.pdf

summary of safety and effectiveness data (ssed)

The lidocaine studies for RHA® Redensity™ for the perioral rhytids were leveraged to support the effectiveness of the mepivacaine products (RHA® Redensity™ Mepi) ...

4.

withpower.com

withpower.com/trial/phase-aging-5-2024-77c11

New Anesthetic Agent for Pain in Aesthetic Treatments

This suggests that the new anesthetic agent in RHA® Redensity could also effectively reduce pain in aesthetic treatments.

5.

researchgate.net

researchgate.net/publication/355111875_Efficacy_and_Safety_of_a_New_Resilient_Hyaluronic_Acid_Filler_in_the_Correction_of_Moderate-to-Severe_Dynamic_Perioral_Rhytides_A_52-Week_Prospective_Multicenter_Controlled_Randomized_Evaluator-Blinde

Efficacy and Safety of a New Resilient Hyaluronic Acid ...

Materials and methods: Blinded live evaluator assessments of efficacy included improvement in perioral rhytides severity using a proprietary ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06378086

RHA® Redensity With New Anesthetic Agent Perioral ...

This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf17/P170002S012B.pdf

fda - summary of safety and effectiveness data (ssed)

RHA® Redensity™ is indicated for injection into the dermis and superficial dermis of the face for, the correction of moderate to severe dynamic perioral rhytids ...