Phase 4 N=485 Randomized Treatment

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

Actinic Keratosis (AK)

Bottom Line

View on ClinicalTrials.gov: NCT01926496 ↗

Enrolled (actual)

485

Serious AEs

5.0%

Results posted

Jul 2020

Primary outcome: Primary: Incidence of SCC — 3.1; 0.4 percentage of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ingenol Mebutate Gel, 0.015% (Drug); Imiquimod Cream, 5% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: LEO Pharma
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of SCC	3.1; 0.4	—
SECONDARY Incidence of SCC and Other Neoplasia	6.2; 2.3	—
SECONDARY Number of Participants With Complete Clearance of AK Lesions After Last Treatment	168; 192	0.03 sig
SECONDARY Number of Participants With Partial Clearance of AK Lesions	195; 210	0.18
SECONDARY Number of Participants With Complete Clearance of AK Lesions at 12 Months	70; 108	<0.001 sig

Summary

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

Eligibility Criteria

Inclusion Criteria

Signed Informed Consent Form (ICF) prior to any trial-related procedures
Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp.
Subject at least 18 years of age
Female subjects must be of either:
Non-childbearing potential, or,
Childbearing potential, provided there is a confirmed negative urine pregnancy test
Female subjects of childbearing potential must be willing to use highly effective methods of contraception (Pearl index < 1%)

Exclusion Criteria

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
Selected treatment area lesions that have atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horn).
History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment area.
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
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)
Organ transplant recipients
Immunosuppressed subjects (for example HIV patients)
Female subjects who are breastfeeding.
Subjects who are institutionalised by court order or by the local authority
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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01926496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.