A Phase 1 interventional study of HF-LED-RL Phototherapy and Mock Therapy in Skin Diseases, Keloid and Scar, sponsored by VA Northern California Health Care System. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-14.
Sponsored by VA Northern California Health Care System · Phase 1, Interventional, and Other
The goal of this study is to establish the safety of high fluence LED-RL at fluence of 480 J/cm2 and 640 J/cm2 in healthy non-Hispanic, Caucasian subjects. The hypothesis is that high fluence LED-RL phototherapy is safe in non-Hispanic, Caucasians.
The effects of visible light, while common in the environment (visible spectrum accounts for 44% of total solar energy), remain undefined. An important safety feature of visible red light (600 nm to 700 nm) is that it does not generate pro-carcinogenic DNA damage as does ultraviolet (UV) light. Recently published clinical observations indicate that red light in combination with other modalities such as photosensitizers in combined red light photodynamic therapy can treat skin diseases. However, preliminary in vitro data generated by the investigator's research group suggests that red light can function as a stand-alone treatment, eliminating the side-effects of chemical photosensitizers and the potential long-term harm of current UV therapy. Furthermore, commercially available light emitting diode-red light (LED-RL) units exist and are already FDA-cleared for other dermatological uses (such as rhytides and acne), thus clinical translation for use in skin diseases could occur relatively quickly following safety and efficacy demonstration. Developing high fluence LED-RL phototherapy as a treatment for skin conditions may represent an important advance that lacks the serious systemic side effects associated with immunomodulatory agents (such as oral steroids); avoids the need for invasive, painful injections with anti-fibrotic agents (such as intralesional steroids, 5-fluorouracil and bleomycin); and eliminates the UV-induced DNA damage associated with skin cancer and photoaging that are associated with current UVA/UVA1 and UVB/narrowband UVB phototherapy. To the investigator research group's knowledge, no clinical trials have been performed to determine the safety of high fluence LED-RL in different Fitzpatrick skin types. The innovation of this approach is that the investigator research group intend to study the safety of high fluence LED-RL in Fitzpatrick skin types I to III (based on NIH's race/ethnicity category of non-Hispanic, Caucasian).
A previous study demonstrated that fluence up to 320 J/cm2 is safe for all skin types (unpublished data, investigator research group). This study will evaluate doses of 480 J/cm2 and 640 J/cm2 in Fitzpatrick skin types I to III. This is based on the classical method for dose escalation as described by Spilker: starting with dose (X) increased by an equal amount (in this instance: X=160 J/cm2 which is the maximum recommended starting dose in clinical studies, 2X=320 J/cm2, 3X=480 J/cm2, 4X=640 J/cm2).
496 studies on the registry are indexed under Skin Diseases; 77 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 375 interventional studies indexed under Skin Diseases.
Browse Skin Diseases studies →VA Northern California Health Care System is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protocol for dose escalation requires subjects be enrolled sequentially in groups of five (three subjects randomized to HF-LED-RL phototherapy and two subjects randomized to mock therapy). After either a maximally tolerated dose (MTD) has been established or the study endpoint of 640 J/cm2 has been achieved, an additional 24 or 27 HF-LED-RL phototherapy subjects (for a total of 30) and 16 or 18 mock therapy subjects (for a total of 20) (determined randomly) will be enrolled to satisfy Hanley's Rule of Three, such that it can be concluded with 95% confidence that fewer than 1 person in 10 will experience an adverse event.
Device: HF-LED-RL Phototherapy
The protocol for dose escalation requires subjects be enrolled sequentially in groups of five (three subjects randomized to HF-LED-RL phototherapy and two subjects randomized to mock therapy). After either a maximally tolerated dose (MTD) has been established or the study endpoint of 640 J/cm2 has been achieved, an additional 24 or 27 HF-LED-RL phototherapy subjects (for a total of 30) and 16 or 18 mock therapy subjects (for a total of 20) (determined randomly) will be enrolled to satisfy Hanley's Rule of Three, such that it can be concluded with 95% confidence that fewer than 1 person in 10 will experience an adverse event.
Device: Mock Therapy
The starting dose of 480 J/cm2 will be administered to Group 1's HF-LED-RL phototherapy randomized subjects and the HF-LED-RL dose will be escalated in the subsequent group to 640 J/cm2. Common expected procedure side effects are mild and temporary, including warmth, redness (erythema) and swelling (edema). The maximally tolerated dose (MTD) is defined as the dose level below the dose producing unacceptable but reversible toxicity in 2 or more subjects and is considered the upper limit of subject tolerance. All subjects will receive total of nine LED-RL phototherapy, three times per week for three consecutive weeks.
Also known as: Omnilux New-U (Photo Therapeutics, Carlsbad, CA)
Mock therapy will be administered to mock therapy randomized subjects using the mock therapy unit. The mock therapy unit only generates warmth and does not emit LED-RL. All subjects will receive total of nine mock therapy procedures, three times per week for three consecutive weeks.
Also known as: Mock therapy unit (Photo Therapeutics, Carlsbad, CA)
Maximum Tolerated Dose (MTD)
The primary objective is to determine the maximum tolerated dose.
Time frame: 3 consecutive weeks
Assessment of safety profile by evaluating incidence of procedure-related common procedure outcomes
To evaluate safety of high fluence LED-RL phototherapy by recording any common expected procedure outcomes \[warmth, erythema (redness), and edema (swelling) that are mild, self-limited, and are expected to last less than 24 hours\] via assessment during and immediately post-procedure and subject diary of adverse events.
Time frame: 3 consecutive weeks
Assessment of safety profile by evaluating incidence of adverse events
To evaluate safety of high fluence LED-RL phototherapy by recording adverse events (including: first-degree or higher skin burning or blistering, erythema lasting more than 24 hours, severe swelling, pain, ulceration, change in sensation, and/or muscle weakness\], via assessment during and immediately post-procedure and subject diary of adverse events.
Time frame: 3 consecutive weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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VA Northern California Health Care System