Levulan® Kerastick®

(aminolevulinic acid HCl) for Topical Solution, 20%

Clinical Study Results

LEVULAN KERASTICK and BLU-U® PDT has proven results in three well-designed clinical trials. A high percentage of patients and the majority of lesions experienced complete clearance which carried through a twelve month period. As you will see from the data below, LEVULAN KERASTICK and BLU-U PDT is an effective therapy that should be prescribed to the appropriate patient.

Complete response demonstrated in a high percentage of patients*

At 8 weeks...

  • 75% clearance of AK lesions was experienced by 77% of patients treated with LEVULAN KERASTICK and BLU-U PDT vs 23% of vehicle-treated patients (p<0.001)
    • 83% of the patients treated with LEVULAN KERASTICK and BLU-U had 75% clearance of face lesions and 60% of the patients had 75% clearance of scalp lesions.
  • 100% clearance of AK lesions was experienced by 66% of patients treated with LEVULAN KERASTICK and BLU-U  PDT vs 13% of vehicle-treated patients (p<0.001)
    • 70% of the patients treated with LEVULAN KERASTICK and BLU-U had 100% clearance of face lesions and 55% of the patients had 100% clearance of scalp lesions.

 

 

Complete response demonstrated in the majority of lesions*

At 8 weeks...

  • 88% of Grade 1 lesions cleared
  • 78% of Grade II lesions cleared

 

* Results from two identically designed, Phase III studies. These were multi-center, blinded, active treatment-controlled, randomized, uneven parallel group, two-arm studies. A total of 243 patients were randomized at a 3 to 1 LEVULAN KERASTICK to vehicle ratio. Patients returned for follow-up visits 24 hours after BLU-U light treatment and at weeks 1, 4 and 8. Those patients who were not complete responders at week 8 had retreatment of the persistent target lesions at week 8. All patients returned at 12 weeks after the initial treatment.

Majority of lesions maintained complete response at 12 months**

64% of lesions treated with LEVULAN KERASTICK and BLU-U PDT maintained complete response at 12 months

**Results from a Phase IV study of 110 patients followed monthly for 12 months. Lesions were designated as cleared if the lesion had completely cleared and adherent scaling plaques of actinic keratoses were no longer evident on the surface of the treated skin when palpated. The percentages of subjects in whom 100% of treated lesions were cleared (Complete Responders) by month, starting at Month 3 (Week 12), are shown above. Of the 72 subjects with 100% of treated lesions cleared (Complete Responders) at Month 3, 53% had a recurrence by Month 12. A total of 748 individual lesions were treated in Study 3; 539 were treated once and 209 were treated twice. At Month 3, 624 lesions (83%) were cleared. From Month 3 through Month 12 of the study, 476 lesions (64%) remained clear. Of the 624 treated lesions determined cleared at Month 3, 24% had recurred by Month 12, while 5% were lost to follow-up and their recurrence status is unknown. 

Cosmetic Response

Most patients evaluated cosmetic response as good to excellent1                 

At 8 weeks...

  • 94% of patients treated with LEVULAN KERASTICK and BLU-U PDT evaluated their cosmetic response as good to excellent vs only 31% of vehicle-treated patients 

 

Physicians rated cosmetic response of most lesions as good to excellent1 

At 8 weeks...

  • 92% of the AK lesions treated with LEVULAN KERASTICK and BLU-U PDT were graded as good to excellent cosmetic response by clinical investigators vs 35% for the vehicle-treated lesions 

 

Tolerability

In addition, LEVULAN KERASTICK and BLU-U PDT is a tolerable therapy:

  • No scarring was reported in clinical trials or post-marketing surveillance
  • In two phase III clinical trials less than 3% of patients discontinued therapy due to stinging and/or burning
  • The sensation of stinging and/or burning appeared to reach a plateau at 6 minutes into the BLU-U light treatment 
  • LEVULAN KERASTICK Topical Solution does not contain peanut or almond oil

 

1 Data on file, DUSA Pharmaceuticals, Inc.

 

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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