Topical Ionic Contra-Viral Therapy in Actinic Keratosis

Actinic Keratosis Clinical Trial

Official title:

A Phase 2, Randomized, Double Blind, Vehicle Controlled, Parallel Group Study to Explore the Efficacy, Pharmacodynamics and Safety of Topical Ionic Contra-Viral Therapy (ICVT) Comprised of Digoxin and Furosemide in Actinic Keratosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03684772
• Other study ID #: CLS003-CO-PR-004
• Status: Recruiting
• Phase: Phase 2
• Start date: October 22, 2018
• Est. completion date: September 2019

Study information

• Verified date: April 2019
• Source: Cutanea Life Sciences, Inc.
• Contact: Robert Rissmann, PhD
• Phone: + 31 71 5246 400
• Email: clintrials[@]chdr.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore the pharmacodynamics and evaluate safety, tolerability and clinical efficacy of ICVT comprised of digoxin and furosemide (dual agent), digoxin (single agent), furosemide (single agent) in patients with AK.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Male or Female subjects 18 years or older with verified condition of general good health (with exception of AK)

• Confirmed clinical AK diagnosis by dermatologist

• Subjects must have at least 2 facial fields of at least 25 cm² (but preferably >35 cm²) present at screening and baseline visit where more than 2 AK lesions are visible in each field (preferably the forehead, temple or cheek)

• Subjects must be able to participate and willing to give written informed consent and to comply with the study restrictions

• Subjects must be able to communicate well with the investigator in Dutch

• Subjects willing to refrain from using other topical products in the treatment area, or prohibited medication for the duration of the study

• Subjects must be willing to limit sun exposure of the involved skin to the extent vocationally possible

• Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.

Exclusion Criteria:

• Have used or received any treatment for AK in the treatment area within 28 days prior to enrollment (including topical medications, immunosuppressive or immunomodulating agents, phototherapy, oral retinoids, or other therapies for AKs)

• Have any current pathologically relevant skin conditions in the field area other than AK (e.g. squamous cell carcinoma or basal cell carcinoma).

• Have a known hypersensitivity to any of the investigational product ingredients, including digoxin and furosemide.

• Current use of systemic digoxin or furosemide.

• Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year

• Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening or intention to donate blood or blood products during the study.

• If a woman of childbearing potential, pregnant, or breast-feeding, or planning to become pregnant during the study.

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• ICVT Topical Gel
Digoxin and Furosemide (0.125%)
• Furosemide Topical Gel
Furosemide (0.125%)
• Digoxin Topical Gel
Digoxin (0.125%)
• Vehicle Topical Gel
Vehicle Gel

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Cutanea Life Sciences, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete clinical clearance (CCC) per field		Day 42
Primary	Change in AK-FAS (AK field assessment scale)	AK Grade 0-IV, the higher the number the more % area covered by AK	Day 42
Primary	Investigator global score (IGS) of each field	This is a 7 point scale from -2 (significantly worse) to +4 (completely cured), higher values represent a better outcome	Day 126
Primary	Evolution of one assigned target lesion in the field, assessed by dermoscopy	assessing erythema, scaling, pigmentation, and follicular plug	Day 126
Primary	Field morphology	Change in lesion count per field	Day 126
Primary	Standardized photography with Canfield VISIA or 2D photography and with Antera 3D camera		Day 126
Primary	Biopsy biomarker	Analysis will be prerformed for the following biomarker: IFN-a. IFN-g, Ki-67	Day 126
Primary	Biopsy biomarker	Analysis will be prerformed for the following biomarker: IFN-g	Day 126
Primary	Biopsy biomarker	Analysis will be prerformed for the following biomarker: Ki-67	Day 126
Primary	Biopsy biomarker	Analysis will be prerformed for the following biomarker: p53	Day 126
Primary	Biopsy biomarker	Analysis will be prerformed for the following biomarker: MCM7(minichromosome maintenance protein 7)	Day 126
Primary	Biopsy biomarker	Analysis will be prerformed for the following biomarker:putrescene	Day 126
Primary	Biopsy biomarker	Analysis will be prerformed for the following biomarker: spermidine	Day 126
Primary	Biopsy biomarker	Analysis will be prerformed for the following biomarker: beta HPV types 5,8,15,20,24,38	Day 126
Primary	Skin swab markers	Swab analysis will be performed for beta HPV types 5,8,15,20,24,38.	Day 126
Secondary	Adverse events collected throughout the study		Day 126
Secondary	12-Lead ECGs performed at Screening and End of Study	The following component will be assessed: Heart Rate (bpm	Day 126
Secondary	12-Lead ECGs performed at Screening and End of Study	The following component will be assessed: PR	Day 126
Secondary	12-Lead ECGs performed at Screening and End of Study	The following component will be assessed: QRS	Day 126
Secondary	12-Lead ECGs performed at Screening and End of Study	The following component will be assessed: QT	Day 126
Secondary	12-Lead ECGs performed at Screening and End of Study	The following component will be assessed: QTcB	Day 126
Secondary	12-Lead ECGs performed at Screening and End of Study	The following component will be assessed: QTcF	Day 126
Secondary	Vital Signs performed at Screening and End of Study	The following will be assessed: Pulse Rate (bpm)	Day 42
Secondary	Vital Signs performed at Screening and End of Study	The following will be assessed: Systolic blood pressure (mmHg)	Day 42
Secondary	Vital Signs performed at Screening and End of Study	The following will be assessed: Diastolic blood pressure (mmHg)	Day 42
Secondary	Vital Signs performed at Screening and End of Study	The following will be assessed: Temperature ( ° C)	Day 42
Secondary	Patient diary on treatment application compliance, local tolerance and selfies photo		Day 42