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

Trial Summary

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.

How does the drug Restylane-L differ from other treatments for sun-damaged skin?

Restylane-L is unique because it is a dermal filler that uses hyaluronic acid to add volume and smooth out wrinkles, unlike other treatments like retinoid creams or light therapies that focus on skin texture and pigmentation. This makes it particularly effective for addressing volume loss in sun-damaged skin. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of the study is to investigate the impact of the injection of dermal filler on the quality of the skin dermal extracellular matrix in persons between the ages of 30-50 years. The quality of the dermal extracellular matrix will be assessed following injection of dermal filler compared to injection of saline vehicle.

Research Team

Gary Fisher

Principal Investigator

University of Michigan

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

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]

References

1. United States 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. [2022]

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

New Insight in Noninvasive Rejuvenation: The Role of a Rhodamine-Intense Pulsed Light System. [2020]

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

Isotretinoin improves the appearance of photodamaged skin: results of a 36-week, multicenter, double-blind, placebo-controlled trial. [2019]

4. United States 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. [2009]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[From the Cochrane Library: Improvement of photodamaged skin with retinoid creams and not with other local treatments]. [2018]