Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%

LEO Pharma

Status and phase: Completed; Phase 4

Conditions: Actinic Keratosis (AK)

Treatments: Drug: Ingenol Mebutate Gel, 0.015%; Drug: Imiquimod Cream, 5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01926496

LP0041-63

2012-003112-31 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 485 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

485 participants in 2 patient groups

Ingenol Mebutate

Experimental group

Description:

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

Treatment:

Drug: Ingenol Mebutate Gel, 0.015%

Imiquimod

Active Comparator group

Description:

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

Treatment:

Drug: Imiquimod Cream, 5%