ingenol disoxate (LEO 43204) / LEO Pharma - LARVOL DELTA

Topical Immunotherapy for Actinic Keratosis and Field Cancerization. (PubMed, Cancers (Basel)) - "While treatments like 5-fluorouracil, imiquimod, photodynamic therapy, and nicotinamide are promising in the management of AKs, especially in immunocompetent individuals, their efficacy is somewhat reduced in solid organ transplant recipients due to immunosuppression. The analysis extends to optimal combination, focusing on cryoimmunotherapy as the most relevant. New immunotherapies include resimiquimod, ingenol disoxate, N-phosphonacetyl-L-aspartate (PALA), or anti-PD1 that have shown promising results, although more studies are needed in order to standardize their use."

Journal • Review • Actinic Keratosis • Dermatology • Immune Modulation • Immunology • Oncology • Solid Organ Transplantation • Transplantation

Efficacy and safety of ingenol disoxate gel in field treatment of actinic keratosis on full face, scalp or large area (250 cm2) on the chest: results of four phase 3 randomized controlled trials. (PubMed, Dermatol Online J) - "Treatment with IngDsx was superior to vehicle on all clinical endpoints, patient-reported and cosmetic outcomes. During the 12-month follow-up, slightly increased skin malignancies in the treatment area were identified, potentially due to unintentional detection bias."

Clinical • Journal • P3 data • Actinic Keratosis • Alopecia • Dermatology • Oncology • Skin Cancer • Solid Tumor

Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up (clinicaltrials.gov) - P3; N=306; Not yet recruiting; Sponsor: LEO Pharma

New P3 trial • Biosimilar

Biological Effects of LEO 43204 in Actinic Keratosis (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: LEO Pharma; Recruiting ➔ Completed; N=32 ➔ 24; Trial primary completion date: Apr 2017 ➔ Dec 2016

Enrollment change • Trial completion • Trial primary completion date • Biosimilar • Ophthalmology

Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up (clinicaltrials.gov) - P3; N=306; Active, not recruiting; Sponsor: LEO Pharma; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar • Ophthalmology

Ingenol Disoxate: A Novel 4-Isoxazolecarboxylate Ester of Ingenol with Improved Properties for Treatment of Actinic Keratosis and Other Non-Melanoma Skin Cancers. (PubMed) - Dermatol Ther (Heidelb) - "These data illustrate that the favorable in vitro and in vivo pharmacological properties driving ingenol mebutate efficacy are either preserved or improved in ingenol disoxate. In combination with improved chemical stability to potentially facilitate storage of the final product at ambient temperatures, these features support further development of ingenol disoxate as a convenient and efficacious treatment modality of non-melanoma skin cancers."

Journal • Biosimilar • Melanoma • Ophthalmology

Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis (clinicaltrials.gov) - P1/2; N=224; Completed; Sponsor: LEO Pharma; Active, not recruiting -> Completed

Trial completion • Biosimilar

Biological Effects of LEO 43204 in Actinic Keratosis (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: LEO Pharma; Trial primary completion date: Oct 2016 ➔ Apr 2017

Trial primary completion date • Biosimilar • Ophthalmology

Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively (clinicaltrials.gov) - P2; N=253; Completed; Sponsor: LEO Pharma; N=188 ➔ 253

Clinical • Enrollment change

Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 in Moderate to Severe Acne (clinicaltrials.gov) - P2; N=59; Completed; Sponsor: LEO Pharma; N=40 ➔ 59

Clinical • Enrollment change