This trial is active, not recruiting.

Condition actinic keratosis (ak)
Treatments ingenol mebutate gel, 0.015%, imiquimod cream, 5%
Phase phase 4
Sponsor LEO Pharma
Start date September 2013
End date June 2018
Trial size 579 participants
Trial identifier NCT01926496, 2012-003112-31, LP0041-63


The purpose of the study is to compare the risk of developing squamous skin cancer (SCC) or other types of cancer after treatment of AKs with ingenol mebutate gel or imiquimod cream. Subjects will be randomised to treatment with ingenol mebutate or imiquimod and will receive a second treatment cycle with the same treatment if the first treatment does not clear all AKs. Subjects will be followed over a period of three year (36 months) after first treatment

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8
ingenol mebutate gel, 0.015% Picato®
Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.
(Active Comparator)
Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8
imiquimod cream, 5% Aldara®
Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs

Primary Outcomes

Incidence of SCC
time frame: 3 years

Secondary Outcomes

Incidence of neoplasia
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Signed Informed Consent Form (ICF) prior to any trial-related procedures 2. Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp. 3. Subject at least 18 years of age 4. Female subjects must be of either: 1. Non-childbearing potential, or, 2. Childbearing potential, provided there is a confirmed negative urine pregnancy test 5. Female subjects of childbearing potential must be willing to use highly effective methods of contraception (Pearl index < 1%) Exclusion Criteria: 1. Location of the selected treatment area: - on the periorbital skin - on the perioral skin/around the nostrils - within 5 cm of an incompletely healed wound - within 10 cm of a suspected BCC or SCC or other neoplasia 2. Selected treatment area lesions that have atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horn). 3. History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment area. 4. History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area 5. Use of ingenol mebutate and/or imiquimod in and within 5 cm of the selected treatment area within 2 years prior to Screening (Visit 1) 6. Organ transplant recipients 7. Immunosuppressed subjects (for example HIV patients) 8. Female subjects who are breastfeeding. 9. Subjects who are institutionalised by court order or by the local authority 10. In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)

Additional Information

Official title A Phase 4 Trial Comparing the Cumulative Incidence of SCC After Treatment With Ingenol Mebutate and Imiquimod for Multiple Actinic Keratoses on Face and Scalp. A Multi-centre, Randomised, Two-arm, Open Label, Active-controlled, Parallel Group, 36-month Trial
Principal investigator Rolf- Markus Szeimies, Professor, Dr. med.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by LEO Pharma.