Clinical trial NCT02305888: Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively
Official title: Safety of LEO 43204 0.018%, 0.037% and 0.1% for Actinic Keratosis Applied Once Daily for Three Consecutive Days on Face/Chest, Scalp and Trunk/Extremities, Respectively
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2014-12-03
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively.


Eligibility criteria: Inclusion Criteria:

Subjects with 5 to 20 clinically typical, visible and, discrete, nonhyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:

* The full face
* The full balding scalp
* A contiguous area of approximately 250 cm2 on trunk or extremities

Exclusion Criteria:

Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.

Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme.

Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months

Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horns) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).

Primary outcomes:
measure: Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions)
timeFrame: 8 days / From baseline (Day 1) to Day 8
Secondary outcomes:
measure: Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
timeFrame: 4 weeks and 8 weeks / From baseline to Week 4, and Week 8
measure: Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
timeFrame: 4 weeks and 8 weeks / From baseline to Week 4, and Week 8
measure: Percentage of Participants With Complete Clearance of AKs
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Smithtown
country: United States
facility: Long Island Skin Cancer and Dermatologic Surgery
state: New York
Study officials:
affiliation: Long Island Skin Cancer and Dermatologic Surgery
name: Daniel M Siegel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siegel DM, Tyring S, Nahm WK, Osterdal ML, Petersen AH, Berman B. Three-day Field Treatment with Ingenol Disoxate (LEO 43204) for Actinic Keratosis: A Phase II Trial. J Clin Aesthet Dermatol. 2017 Dec;10(12):19-26. Epub 2017 Dec 1.
citation: Berman B, Tyring S, Nahm WK, Osterdal ML, Petersen AH, Siegel DM. Three-Day Field Treatment with Ingenol Disoxate (LEO 43204) for Actinic Keratosis: Cosmetic Outcomes and Patient Satisfaction from a Phase II Trial. J Clin Aesthet Dermatol. 2017 Nov;10(11):26-32. Epub 2017 Nov 1.