Live Blog: Product Theater for Leo Pharmaceuticals: “Picato Gel – Not Your Typical Topical.” Faculty: Michael Borenstein, MD
In this live blog from the Annual Fall SDPA Conference in Orlando, FL, Michael Borenstein, MD, presented product theater for Leo Pharmaceuticals on “Picato gel – Not Your Typical Topical.” Here are some of the highlights.
In 2004, actinic keratosis (AK) prevalence was estimated in excess of 58 million people. However, public awareness of the disease may be low. An international survey of households found that only 7% were familiar with AK.
AK is often a chronic condition and new lesions may emerge over time. Additionally, relapses of treated lesions has been reported. Treatment options for AK include lesion-directed therapy and field-directed therapy. Cryosurgery is most common treatment.
Picato gel is indicated for topical treatment of AK. One of the most notable features of Picato gel is that it has a very short application cycle (three days for the face or scalp and 2 days for the trunk or extremities).
- On the face or scalp: Apply Picato gel 0.015% topically to the treatment area (no more than 25 cm2) once daily for 3 consecutive days. Avoid application of Picato gel in, near, and around the eyes, in the mouth, and on the lips.
- On the trunk or extremities: Apply Picato gel 0.05% topically up to a 25 cm2 treatment area once daily for 2 consecutive days.
- Do not apply it to more than one area simultaneously.
Dr. Bornstein emphasized that educating the patient about the most possible severe skin reactions is very important so that the patient doesn’t get scared or upset when skin irritation occurs. The patient should know that irritation is expected to happen at application site. However, not all patients will experience the most severe reactions. Most irritation resolves by two weeks after treatment. Dr. Borenstein said, “Teach them what to expect. An informed patient is a happy patient.” Contrarily, Patients should also know that if they do not have skin irritation from Picato gel that it does not mean the drug didn’t work. The severity of the reaction is not related to the efficacy of the drug.
Severe skin reactions in the treated areas on the face/scalp and trunk/extremities, including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration can occur after application. Administration of Picato® gel is not recommended until the skin is healed from any previous drug or surgical treatment. The most common adverse reactions observed in clinical trials on the face and scalp (≥2%) are local skin reactions (94%), application site pain (15%), application site pruritus (8%), application site infection (3%), periorbital edema (3%), and headache (2%). The most common adverse reactions observed in clinical trials on the trunk and extremities (≥2%) are local skin reactions (92%), application site pruritus (8%), application site irritation (4%), nasopharyngitis (2%), and application site pain (2%).
To avoid accidental transfer of Picato gel to other areas or to another person, instruct patients to: wash their hands well with soap and water after applying Picato gel and allow the treated area to dry for 15 minutes after application. Avoid showering, washing, and touching the treated area or participating in activities that cause excessive sweating for 6 hours after treatment. After this time, patients may wash the area with a mild soap. Keep Picato gel out of the reach of children, store the gel in the refrigerator, and encourage patients to read the patient information leaflet.
More information about Picato gel can be found at www.picato.com.
Image: Kevin Thiele