Broadband Light for Age Spots

Overseen By Jay Patel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sciton

Must not be taking: Anticoagulants, Immunosuppressants, Retinoids, Corticosteroids

Disqualifiers: Pregnancy, Diabetes, Cardiovascular disease, Seizure disorders, 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: Unknown

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of broadband light treatment to reduce age spots, specifically solar lentigines, which are dark patches on the skin caused by sun exposure. The aim is to assess the effectiveness of this light treatment for individuals with moderate to severe skin pigmentation issues. Participants should have visible age spots and be willing to follow specific guidelines, such as avoiding sun exposure. This trial may suit those who can commit to regular visits and are open to having photographs taken for research purposes. As an unphased trial, this study offers a unique opportunity for participants to contribute to pioneering research in skin treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you are taking prescription anticoagulation medications, immunosuppressive medications, or medications that increase sensitivity to light. Also, you must not have used systemic retinoids or corticosteroids within 6 months, or topical retinoids, corticosteroids, or hydroquinone on the target area within 1 month before the study.

What prior data suggests that Broadband Light is safe for treating age spots?

Research has shown that broadband light treatment is generally safe and well-tolerated. Studies have found it effective for treating age spots and other skin issues. This treatment resembles intense pulsed light (IPL) therapy, which is gentle on the skin. Although it may require more sessions than laser therapy, it remains a safe option for enhancing skin appearance. Reports of harmful side effects are rare, making it a promising choice for reducing age spots. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for age spots, like topical creams or chemical peels, work by gradually lightening the skin over time. However, Broadband Light (BBL) therapy is unique because it uses intense pulses of light to target and eliminate excess pigmentation in the skin. This approach can offer more immediate and precise results compared to traditional methods. Researchers are excited about BBL because it has the potential to provide quicker improvements in skin tone with minimal downtime, making it an appealing option for those seeking efficient and effective treatment for age spots.

What evidence suggests that Broadband Light is effective for Solar Lentigines?

Research has shown that Broadband Light (BBL), also known as Intense Pulsed Light (IPL), effectively treats age spots, such as those from sun exposure. One study found that 62% of patients experienced more than a 50% improvement, while 23% saw over a 75% improvement in their skin condition. Another report confirmed that BBL effectively reduces sun-related age spots, especially when combined with other treatments. These findings suggest that BBL can significantly reduce age spots without serious side effects. ^{3 5 6 7 8}

Who Is on the Research Team?

Jonathan Cook, MD

Principal Investigator

Sanctuary Plastic Surgery

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18 with moderate to severe skin pigmentation who are not pregnant, don't plan to be during the study, and agree to limited sun exposure and using SPF 50 sunscreen. Excluded are those with certain skin conditions, recent cosmetic treatments in the area, or increased light sensitivity due to medications.

Inclusion Criteria

I am not planning to become pregnant and will use birth control during the study.

Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes

Agree not to make any changes in their skin regimen for the duration of the study, including the follow-up period

Exclusion Criteria

I haven't used retinoid, corticosteroid, or hydroquinone on the target area in the last month.

History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen

I have a history of abnormal or excessive scarring.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Broadband light treatment for Solar Lentigines

1 month

Follow-up

Participants are monitored for histological changes in skin post treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Broadband Light

Trial Overview The trial tests Broadband Light treatment's effectiveness on solar lentigines (sunspots). Participants will receive this non-invasive light therapy and must follow specific skincare routines without making changes throughout the study.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Each subject will receive Broadband light treatment

Broadband Light is already approved in United States, European Union, Canada for the following indications:

Approved in United States as BBL for:

• Solar Lentigines
• Rosacea
• Acne
• Fine Lines
• Wrinkles
• Skin Texture Improvement
• Sun Damage
• Age Spots
• Hyperpigmentation

Approved in European Union as BBL for:

• Solar Lentigines
• Rosacea
• Acne
• Fine Lines
• Wrinkles
• Skin Texture Improvement
• Sun Damage
• Age Spots
• Hyperpigmentation

Approved in Canada as BBL for:

• Solar Lentigines
• Rosacea
• Acne
• Fine Lines
• Wrinkles
• Skin Texture Improvement
• Sun Damage
• Age Spots
• Hyperpigmentation

Who Is Running the Clinical Trial?

Sciton

Lead Sponsor

Trials

20

Recruited

1,400+

Published Research Related to This Trial

The study found that using higher fluence levels and fewer pulse counts with the 515 nm filter in Intense Pulsed Light (IPL) treatments led to the best clinical outcomes for reducing erythema and pigmentation after 4 weeks, particularly in individuals with Fitzpatrick Skin Type III.

However, aggressive IPL settings can increase the risk of side effects like hypopigmentation and hair loss, highlighting the importance of adjusting device settings based on skin type and using multiple sequence pulsing (MSP) to enhance safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense Pulsed Light: A Methodical Approach to Understanding Clinical Endpoints. Lipp, MB., Angra, K., Wu, DC., et al.[2021]

Intense pulsed light (IPL) is a versatile nonlaser treatment effective for various skin issues, including vascular and pigmented lesions, photo damage, active acne, and unwanted hair.

Modern IPL systems have significant advancements over older models, featuring better calibration, integrated cooling, and improved tuning, making them popular choices in many medical offices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense Pulsed Light Therapy for Skin Rejuvenation. DiBernardo, BE., Pozner, JN.[2018]

In a pilot study involving 8 volunteers, both intense pulsed light (IPL) and advanced fluorescent technology (AFT) devices showed similar efficacy in improving skin conditions like dyspigmentation and texture after 3 to 5 treatments, indicating both are effective for photodamage.

No significant adverse effects were reported, and subjects experienced comparable levels of discomfort during treatments, suggesting both methods are safe options for skin rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense pulsed light versus advanced fluorescent technology pulsed light for photodamaged skin: a split-face pilot comparison. Braun, M.[2007]

In a study of patients with solar lentigines and ephelides, intense pulsed light (IPL) treatment resulted in over 50% improvement for 48% of patients, with 20% experiencing more than 75% improvement, indicating its efficacy for skin photoaging.

IPL was well tolerated among participants, suggesting it could be a safe and effective new treatment option for solar lentigines and ephelides, particularly in patients with smaller skin lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical improvement of solar lentigines and ephelides with an intense pulsed light source. Kawada, A., Shiraishi, H., Asai, M., et al.[2019]

Intense pulsed light (IPL) treatment significantly improved signs of photoaging in dark skin, with global photoaging scores decreasing from 3.02 to 1.22 after four treatments, while the untreated side showed no change.

The treatment led to a significant reduction in melanin content and an increase in collagen fibers on the treated side, with minimal adverse effects reported, such as mild pain and transient erythema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A split-face study of intense pulsed light on photoaging skin in Chinese population. Li, YH., Wu, Y., Chen, JZ., et al.[2022]

A 21-year-old woman experienced severe blistering and facial edema after receiving intense pulsed light (IPL) treatment for rosacea, indicating potential risks associated with IPL therapy, especially when administered by non-physicians.

The case suggests that high-fluence IPL can cause significant tissue injury, leading to complications such as vesicobullae formation, and emphasizes the need for caution and proper training in the use of IPL technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vesiculobullous eruption from intense pulsed light treatment. Sperber, BR., Walling, HW., Arpey, CJ., et al.[2019]

Intense pulsed light (IPL) is an effective treatment for vascular and pigmented skin lesions associated with photoaging, demonstrating its efficacy in improving skin appearance.

IPL can also be combined with photodynamic therapy, enhancing its use in treating early forms of skin cancer, highlighting its versatility in dermatological applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense pulsed light as a nonablative approach to photoaging. Goldman, MP., Weiss, RA., Weiss, MA.[2022]

In a study involving 20 female patients, the combination of Intense Pulsed Light (IPL) and Nd:YAG laser treatments resulted in significantly better histological improvements and higher patient satisfaction scores compared to IPL alone, with satisfaction scores of 80% in the combined treatment group versus 60% and 40% in the IPL-only group at 1 and 6 months, respectively.

Both treatment groups showed minimal discomfort and side effects, indicating that the combined IPL and Nd:YAG approach is a safe and effective option for non-ablative skin rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nd:YAG laser combined with IPL treatment improves clinical results in non-ablative photorejuvenation. Trelles, M., Allones, I., Vélez, M., et al.[2019]

In a study involving 101 volunteers with various skin types, the new intense pulse light (IPL) technology demonstrated significant efficacy in treating conditions like hair removal, acne, and vascular lesions, with no serious adverse events reported.

The treatment was particularly effective for hair removal, with all patients achieving significant clearance, and those with facial rosacea responding the fastest, highlighting the importance of tailoring treatment settings to individual skin types and conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense Pulsed Light Pulse Configuration Manipulation Can Resolve the Classic Conflict Between Safety and Efficacy. Belenky, I., Tagger, C., Bingham, A.[2015]

A retrospective review of 2534 patients who received at least 3 intense pulsed light (IPL) treatments showed an impressive effectiveness rate of 88.24% to 96.45% in treating photoaging.

Long-term follow-up with yearly clinical photographs over up to 12 years indicates that IPL therapy can significantly reverse signs of skin photodamage, making it a reliable option for skin rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective study on the clinical efficacy of the intense pulsed light source for photodamage and skin rejuvenation. Ping, C., Xueliang, D., Yongxuan, L., et al.[2017]

In a study involving five women undergoing five sessions of nonablative full-face resurfacing with intense pulsed light (IPL), all participants showed significant clinical and microscopic improvements in skin features such as wrinkles and thickness.

IPL treatment for facial photodamage demonstrated promising results with minimal side effects and downtime, indicating it could be a safe and effective rejuvenation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gross and microscopic findings in patients submitted to nonablative full-face resurfacing using intense pulsed light: a preliminary study. Hernández-Pérez, E., Ibiett, EV.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11460752/

A Novel Combination of BroadBand Light (BBL® HEROTM ... The results presented in this report demonstrate that combining BBL HERO and MOXI is effective for reducing solar lentigines.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22515674/

Clinical effectiveness of intense pulsed light therapy for ... Sixty-two percent of patients had more than 50% improvement and 23% had more than 75% improvement. No patients discontinued due to adverse effects, and no ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/j.1529-8019.2012.01426.x

Clinical effectiveness of intense pulsed light therapy for ... Sixty-two percent of patients had more than 50% improvement and 23% had more than 75% improvement. No patients discontinued due to adverse ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0923181102000142

Videomicroscopic and histopathological investigation of ... A noncoherent, broadband, intense pulsed light source has been effective for symptoms of photoaging skin as a nonablative method. The purpose of this study ...

5. withpower.com withpower.com/trial/phase-lentigo-2-2024-9ac24

Broadband Light for Age Spots · Info for Participants The available research shows that Broadband Light, also known as Intense Pulsed Light (IPL), is effective for treating age spots. One study highlights its use ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK580525/

Intense Pulsed Light (IPL) Therapy - StatPearls - NCBI Bookshelf IPL is safe and effective in treating benign pigmented and vascular disorders as well as performing hair removal and reducing signs of photoaging.

7. webmd.com webmd.com/beauty/intense-pulsed-light-treatment-overview

Intense Pulsed Light Therapy (IPL Treatment) The main difference is that IPL therapy is gentler on the skin and usually requires more sessions than laser therapy for comparable results.

8. oatext.com oatext.com/Clinical-evaluation-of-the-efficacy-and-safety-of-combined-bipolar-radiofrequency-and-optical-energies-vs-optical-energy-alone-for-the-treatment-of-pigmented-lesions-and-photo-damage-in-aging-hands.php

Clinical evaluation of the efficacy and safety of combined ... This study demonstrates the safety and efficacy of combining RF and optical energies for the aesthetic improvement of aging hands.