Restylane-L for Sun-Damaged Skin

Overseen By Diane Fiolek

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Immunosuppressants, Anticoagulants

Disqualifiers: Pregnancy, Bleeding disorders, Keloids, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a dermal filler called Restylane-L can improve skin damaged by excessive sun exposure. The study compares the effects of the filler to a simple saline solution. It targets individuals aged 30 to 50 with sun-damaged skin who are generally in good health. Those with skin conditions like frequent herpes infections or sensitivity to lidocaine should not participate. The aim is to determine if the filler can enhance the skin's structure and appearance. As an unphased trial, this study allows participants to contribute to understanding the potential benefits of Restylane-L for sun-damaged skin.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that suppress your immune system or have used blood thinners in the last 3 weeks.

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

Research has shown that Restylane-L, a type of skin filler, has generally been well-received in past studies. In one study, about 53% of participants with different skin types reported no side effects. Overall, the side effects reported for Restylane-L were similar to those seen with other skin fillers.

Most people experienced only mild side effects, such as redness or swelling at the injection site. Serious cases, like mild skin damage and abscesses, were rare. Importantly, Restylane-L has not been removed from the market due to safety concerns, suggesting it is considered safe to use.

This information may be helpful for those considering joining a trial involving Restylane-L for sun-damaged skin. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for sun-damaged skin, which often include topical creams and laser therapies, Restylane-L offers a unique approach by utilizing hyaluronic acid, a substance naturally found in the skin. This injectable treatment not only aims to hydrate and restore volume to the damaged skin but also provides immediate and visible results, which is a key advantage over options that typically take longer to show improvements. Researchers are particularly excited about its potential to address both the aesthetic and structural aspects of sun-damaged skin, offering a more comprehensive rejuvenation.

What evidence suggests that Restylane-L might be an effective treatment for sun-damaged skin?

Research has shown that Restylane-L effectively reduces moderate to severe facial wrinkles and folds. This treatment involves injecting a gel-like substance into the skin to fill and smooth out lines. The FDA has approved it for cosmetic use, and results can last up to a year. In this trial, researchers are testing Restylane-L for its potential to improve sun-damaged skin by strengthening the skin's supportive framework. Studies confirm its safety and demonstrate that it can visibly enhance skin quality. ^{1 4 6 7 8}

Who Is on the Research Team?

Gary Fisher

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged 30-50 looking to improve skin quality, who can follow the study's protocol. It's not suitable for pregnant or nursing women, those with bleeding disorders, keloid scarring, lidocaine sensitivity (including epilepsy and severe organ dysfunction), active skin infections or inflammation, excessive planned sun exposure after treatment, allergies to certain proteins, recent use of blood thinners or immune suppressants.

Inclusion Criteria

Subjects must understand and sign the informed consent prior to participation

Subjects must be in generally good health

Subjects must be able and willing to comply with the requirements of the protocol

Exclusion Criteria

Have a lidocaine sensitivity, including those with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction

History of allergies to gram positive bacterial proteins

Pregnant, plan to become pregnant during the study, or are nursing a child. Participants will be asked to self-report pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of dermal filler or saline vehicle to assess the impact on the dermal extracellular matrix

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in the extracellular matrix using histological stains

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Restylane-L
• Vehicle

Trial Overview The study tests how a dermal filler called Restylane-L affects the skin's extracellular matrix compared to a saline solution in people aged 30-50. Participants will receive injections and their skin quality will be assessed afterwards.

How Is the Trial Designed?

Group I: Photodamaged skin Experimental Treatment 2 Interventions

Restylane-L is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Restylane-L for:

• Moderate to severe facial wrinkles and folds
• Lip augmentation

Approved in European Union as Restylane for:

• Facial wrinkles and folds
• Lip augmentation
• Nasolabial folds

Approved in Canada as Restylane-L for:

• Moderate to severe facial wrinkles and folds
• Lip augmentation

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Galderma R&D

Industry Sponsor

Trials

303

Recruited

60,700+

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD

Published Research Related to This Trial

In an eight-week study involving 36 women with moderate facial photodamage, a stabilized 0.1% retinol moisturizer significantly improved skin conditions like lines, wrinkles, and pigmentation compared to a vehicle, showing efficacy as early as four weeks.

The study confirms that the retinol formulation is safe and effective for reducing signs of photoaging, making it a promising option for skincare treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A stabilized 0.1% retinol facial moisturizer improves the appearance of photodamaged skin in an eight-week, double-blind, vehicle-controlled study. Tucker-Samaras, S., Zedayko, T., Cole, C., et al.[2009]

In a double-blind clinical trial involving 800 patients, 0.1% isotretinoin cream significantly improved the appearance of moderate to severe photodamaged skin compared to a vehicle cream over a 36-week period.

The treatment was well-tolerated with minimal local irritation, indicating that isotretinoin is a safe option for addressing photodamage caused by UV exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isotretinoin improves the appearance of photodamaged skin: results of a 36-week, multicenter, double-blind, placebo-controlled trial. Maddin, S., Lauharanta, J., Agache, P., et al.[2019]

In a study involving 20 female volunteers, long-pulsed dye laser (LPDL) treatments showed superior effectiveness in clearing telangiectasias compared to intense pulsed light (IPL) treatments, with significant improvements noted at 3 and 6 months post-treatment.

Patients reported significantly less pain with LPDL compared to IPL, and overall preferred LPDL treatments, highlighting its advantages in both efficacy and comfort for skin rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-pulsed dye laser versus intense pulsed light for photodamaged skin: a randomized split-face trial with blinded response evaluation. Jørgensen, GF., Hedelund, L., Haedersdal, M.[2022]

Rhodamine-intense pulsed light (r-IPL) treatment showed significant improvement in facial photodamaged skin, with FEWS scores decreasing from 7 to 2 after five sessions, indicating reduced wrinkles and better texture.

The treatment was well-tolerated with minimal pain (average VAS score of 3/10) and no significant adverse events, suggesting r-IPL is a safe and effective option for noninvasive photorejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Insight in Noninvasive Rejuvenation: The Role of a Rhodamine-Intense Pulsed Light System. Cannarozzo, G., Bonciani, D., Tamburi, F., et al.[2020]

Topical tretinoin (≥0.02%) was found to significantly improve the appearance of mild-to-severe photodamage in a systematic review of 30 randomized clinical trials, with treatment durations ranging from 4 to 11 months.

Tazarotene (0.01-0.1%) and isotretinoin (0.1%) also showed benefits for moderate photodamage, but all treatments had dose-dependent adverse effects, including pain and redness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[From the Cochrane Library: Improvement of photodamaged skin with retinoid creams and not with other local treatments]. Hamerlynck, JV., Middeldorp, S., Scholten, RJ.[2018]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf4/P040024S056b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Restylane-L is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf4/P040024S056c.pdf

noout Restylane-L Q Has Restylane-L been studied? You may experience skin discoloration (bruising), may lead to other side effects such as inflammation. swelling, redness, tenderness, pain, itching, or. You ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11334209/

A Multicenter, Randomized, Evaluator-Blinded Study to ... The objective of this study was to examine the effectiveness (IOH correction) and safety of Restylane Eyelight hyaluronic acid (HA EYE ) injections.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04488939

Restylane® Skinboosters™ Vital in the décolletage Region | ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

5. rendoncenter.com rendoncenter.com/cosmetic-dermatology/dermal-fillers/restylane/

Restylane® Dermal Fillers in Boca Raton | Natural Results Restylane is completely safe and is approved by the FDA for cosmetic use; Restylane provides up to one year of results; Restylane can offer improvement in just ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf4/P040024S051b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Restylane has not been removed from the marketplace for any reasons related to safety, effectiveness, patient or physician complaint, or dissatisfaction. VIII.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11766492/

Safety and Potential Complications of Facial Wrinkle ... Out of the 8795 complications, 1076 were adverse events (AE), including two severe AE cases: mild skin necrosis (n = 1) and abscess (n = 1).

8. galderma.com galderma.com/us/sites/default/files/2022-04/Restylane-L_USA_IFU.pdf

Instructions for Use Restylane-L US Safety. Severity and duration of injection site reactions and adverse events were recorded. Outcomes. Demographics: The study enrolled an adult population of ...