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 Risk Information
LEVULAN KERASTICK 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.

Application of LEVULAN KERASTICK should involve either scalp or face lesions, but not both simultaneously. LEVULAN KERASTICK should not be applied to the periorbital area or allowed to contact ocular or mucosal surfaces. Excessive irritation may be experienced if this product is applied under occlusion.

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 for Topical Solution.

LEVULAN KERASTICK has not been tested on patients with inherited or acquired coagulation defects. It is possible that concomitant use of other known photosensitizing agents might increase the photosensitivity reaction of actinic keratoses treated with the LEVULAN KERASTICK.

Patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light for at least 40 hours after LEVULAN KERASTICK application. Exposure may result in a stinging and/or burning sensation and may cause erythema or edema of the lesions. Patients should protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material. Sunscreens will not protect against photosensitivity reactions caused by visible light.

Transient local symptoms of stinging and/or burning, itching, erythema, and edema were observed in all clinical studies. Severe stinging and/or burning at one or more lesions being treated was reported by at least 50% of patients at some time during treatment. However, less than 3% of patients discontinued light treatment due to stinging and/or burning.

During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear, as specified in the BLU-U operating instructions to minimize ocular exposure.

WEB 1424 Rev G