BLU-U®

Blue Light Photodynamic Therapy Illuminator
Model 4170

BLU-U® - Unique and Patented Design

The BLU-U for actinic keratoses (AKs) - optimal design for treating AKs on the face or scalp

Clinical Output

  • As you know, AKs reside within the epidermis which is less than 2 mm thick.1 The BLU-U blue light penetrates up to 2 mm of skin.2  
  • The BLU-U also has enough energy to produce a photodynamic response. In our Phase II study the maximum clinical response with Levulan® Kerastick® (aminolevulinic acid HCl) Topical Solution, 20% was produced at 10 J/cm2 at 1000 seconds.
  • Finally, BLU-U output is matched to the highest absorption peak of PpIX.3  It’s peak wavelength occurs at 417 ±5 nm and the maximum absorption peak for porphyrins occurs at 410 nm.3,4

 

Design Features

The BLU-U is designed to deliver a uniform light dose and stable wavelength to an entire treatment area.3

  • The large U-shaped design and tube spacing allows for the treatment of an entire face or scalp while delivering a consistent light dose all the way to the treatment edges.
  • The unit is designed with a stainless steel reflective wall behind the tubes to minimize loss of light within the U-shaped treatment area.
  • Light tubes are spaced much closer together at the top and bottom than in the middle to compensate for light falloff in this area.

 

The BLU-U is designed to deliver a consistent light dose.3

  • The phosphor in the fluorescent tubes produces a very stable and cost-effective wavelength.
  • The BLU-U contains a microprocessor that continuously monitors and adjusts light output to maintain dose stability from the first to the last treatment. 

Use with eyewear that blocks light of at least 500 nm and shorter with an optical density of two or greater. BLU-U does not emit UVA or UVB light. 

BLU-U for Acne - Innovative, Simple, Effective

The BLU-U offers effective, non-invasive and pain-free blue light treatment for moderate inflammatory acne vulgaris. Narrow band blue light causes a photodynamic effect within the pilosebaceous gland that kills P. acnes, the bacteria primarily responsible for acne vulgaris. When used in a series of brief (approximately 17 minutes) exposure sessions, it provides a simple, non-invasive treatment regimen. BLU-U treatments can be a primary treatment, an alternative to pharmaceuticals and topicals, or an adjunct to skin care programs.

 

Blu-u Diagram

 

 

1 http://dermatology.about.com/cs/skinanatomy/a/anatomy.htm.

2 MacCormack, MA. Photodynamic Therapy. Advances in Dermatology. 2006;22:219-258.

3 Data on file, DUSA Pharmaceuticals, Inc.

4 Taub, AF. Photodynamic Therapy in Dermatology; History and Horizons. J. Drugs Dermatol. 2004;3:S8-S25.

 

Important Safety Information

LEVULAN® KERASTICK® (aminolevulinic acid HCl) for topical solution, 20%, plus blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp, or actinic keratosis of the upper extremities.

Contraindicated in patients with cutaneous photosensitivity at wavelengths of 400–450 nm, porphyria, or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the LEVULAN KERASTICK topical solution.

Application of LEVULAN KERASTICK topical solution should involve lesions on the face or scalp, or upper extremities. Multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously.

Do not apply to the eyes or to mucus membranes. Irritation may be experienced if LEVULAN KERASTICK topical solution is applied to eyes or mucous membranes. Treatment of upper extremities is approved after an incubation time of 3 hours under occlusion. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours.

Transient amnestic episodes have been reported during postmarketing use of LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Inform patients and their caregivers that LEVULAN KERASTICK in combination with PDT may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.

After LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. To avoid unintended photosensitivity, LEVULAN KERASTICK topical solution should be applied by a qualified health professional to no more than 5 mm of perilesional skin surrounding each target actinic keratosis lesion.

Advise patients to wear a wide-brimmed hat or similar head covering of light-opaque material or a long-sleeved shirt and/or gloves to shade the treated actinic keratoses from sunlight or other bright light sources until at least 40 hours after the application of LEVULAN KERASTICK topical solution. Sunscreens will not protect against photosensitivity reactions caused by visible light. The patient should be advised to reduce light exposure if the sensations of stinging and/or burning are experienced.

LEVULAN KERASTICK topical solution has not been tested on patients with inherited or acquired coagulation defects.

It is possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction of actinic keratoses treated with the LEVULAN KERASTICK topical solution.

During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear as specified in the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions.

The most common local adverse reactions (incidence ≥ 10%) were erythema, edema, stinging/burning, scaling/crusting, itching, erosion, hypo/hyperpigmentation, oozing/vesiculation/crusting, scaling and dryness.

In clinical trials, severe stinging and/or burning was reported by at least 50% of face and scalp patients and 9% of upper extremity patients at some time during treatment. However, less than 3% of subjects receiving treatment for face or scalp lesions discontinued light treatment because of stinging/burning. No subjects discontinued light treatment in the trial for upper extremity lesions.

Please refer to the full Prescribing Information for complete discussion of the risks associated with LEVULAN KERASTICK (aminolevulinic acid HCl) for topical solution, 20%.

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