Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively

Actinic Keratosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305888
• Other study ID #: LP0084-1148
• Status: Completed
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: August 2015

Study information

• Verified date: February 2019
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• LEO 43204
Treatment of actinic keratosis

Locations

Country	Name	City	State
United States	Long Island Skin Cancer and Dermatologic Surgery	Smithtown	New York

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions)	For face/chest, a DLT was defined as one or more of the following three LSRs: Crusting Grade 4; Erosion/Ulceration Grade 4; Vesiculation/Pustulation Grade 4; Or two or more of the following five LSRs: Erythema Grade 4; Crusting Grade 3; Swelling Grade 4; Erosion/Ulceration Grade 3; Vesiculation/Pustulation Grade 3; For scalp a DLT was defined as erosion/ulceration Grade 4; For trunk/extremities a DLT was defined as one or more of the following three LSRs: Crusting Grade 4; Erosion/Ulceration Grade 4; Vesiculation/Pustulation Grade 4; Or two or more of the following four LSRs: Crusting Grade 3; Swelling Grade 4; Erosion/Ulceration Grade 3; Vesiculation/Pustulation Grade 3	8 days / From baseline (Day 1) to Day 8
Secondary	Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic	The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at baseline (Day 1), Week 4, and Week 8. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.	4 weeks and 8 weeks / From baseline to Week 4, and Week 8
Secondary	Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic	Hypertrophic/Hyperkeratotic lesions were identified at baseline (Day 1), Week 4 and Week 8.	4 weeks and 8 weeks / From baseline to Week 4, and Week 8
Secondary	Percentage of Participants With Complete Clearance of AKs	Complete clearance was defined as no clinically visible AKs. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.	8 weeks

External Links

•   Clinical Trials at LEO Pharma