New Anesthetic Agent for Pain in Aesthetic Treatments

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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection. At screening, the Principal Investigator (PI) evaluated subjects' perioral rhytid severity (using the Perioral Rhytid Severity Rating Scale; PR-SRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement. At Visit 1, RHA® Redensity with new anesthetic agent was administered in a random sequence (first or second injection) and side of the mouth (left or right) and RHA® Redensity with lidocaine was administered to the other side. Study subjects and the PI injecting study devices were blinded. Immediately after injection of an upper perioral quadrant, subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the mouth was also assessed at 15, 30, 45 and 60 minutes after injection of the upper quadrant. Safety evaluation consisted of AE assessments, a 30-day CTR (Common Treatment Response) diary and a follow-up call performed by the study site at 72 hours after injection. Subjects attended Visit 2 (30 days post-injection) where effectiveness and safety assessments were conducted. Subjects who presented with an unresolved clinically significant device related AE at Visit 2 received a optional follow-up phone call no later than 30 days after Visit 2. If the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary.

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.

What data supports the effectiveness of the new anesthetic agent in the treatment RHA® Redensity with lidocaine for pain in aesthetic treatments?

Research shows that adding lidocaine to fillers like hyaluronic acid and calcium hydroxylapatite significantly reduces pain during injections, making the procedure more comfortable for patients. This suggests that the new anesthetic agent in RHA® Redensity could also effectively reduce pain in aesthetic treatments. ^{1 2 3 4 5}

Is the new anesthetic agent generally safe for use in humans?

Lidocaine, a commonly used anesthetic, is generally safe with rare adverse reactions, including mild local side effects like bruising and swelling. True allergic reactions to lidocaine are extremely rare, occurring in about 1% of cases. ^{6 7 8 9 10}

What makes the new anesthetic agent in RHA® Redensity unique for pain in aesthetic treatments?

The new anesthetic agent in RHA® Redensity is unique because it is combined with lidocaine, which is known to reduce pain during aesthetic procedures, potentially offering enhanced comfort compared to treatments without lidocaine. ^{1 2 4 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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 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]

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]

References

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

Calcium Hydroxylapatite With Integral Lidocaine Provides Improved Pain Control for the Correction of Nasolabial Folds. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Longevity of effects of hyaluronic acid plus lidocaine facial filler. [2013]

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

Hand augmentation with Radiesse (Calcium hydroxylapatite). [2013]

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

Ten commandments for minimal pain during administration of local anesthetics. [2005]

5. England pubmed.ncbi.nlm.nih.gov

Benefits of adding lidocaine to a hyaluronic gel - Stylage® M. [2013]

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

Case reports: type I hypersensitivity to lidocaine. [2013]

7. England pubmed.ncbi.nlm.nih.gov

An adverse reaction to local anaesthesia: report of a case. [2013]

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

A comparison between articaine HCl and lidocaine HCl in pediatric dental patients. [2022]

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

Localized complications from local anesthesia. [2005]

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

Delayed-type hypersensitivity to lidocaine. [2019]

11. England 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. [2015]

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

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