Topical Ionic Contra-Viral Therapy in Actinic Keratosis

NCT03684772 | Unknown Phase 2

• 1 other identifier: CLS003-CO-PR-004
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (15)

• Complete clinical clearance (CCC) per field

  Day 42

• Change in AK-FAS (AK field assessment scale)

  AK Grade 0-IV, the higher the number the more % area covered by AK

  Day 42

• 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

• Evolution of one assigned target lesion in the field, assessed by dermoscopy

  assessing erythema, scaling, pigmentation, and follicular plug

  Day 126

• Field morphology

  Change in lesion count per field

  Day 126

• Standardized photography with Canfield VISIA or 2D photography and with Antera 3D camera

  Day 126

• Biopsy biomarker

  Analysis will be prerformed for the following biomarker: IFN-a. IFN-g, Ki-67

  Day 126

• Biopsy biomarker

  Analysis will be prerformed for the following biomarker: IFN-g

  Day 126

• Biopsy biomarker

  Analysis will be prerformed for the following biomarker: Ki-67

  Day 126

• Biopsy biomarker

  Analysis will be prerformed for the following biomarker: p53

  Day 126

• Biopsy biomarker

  Analysis will be prerformed for the following biomarker: MCM7(minichromosome maintenance protein 7)

  Day 126

• Biopsy biomarker

  Analysis will be prerformed for the following biomarker:putrescene

  Day 126

• Biopsy biomarker

  Analysis will be prerformed for the following biomarker: spermidine

  Day 126

• Biopsy biomarker

  Analysis will be prerformed for the following biomarker: beta HPV types 5,8,15,20,24,38

  Day 126

• Skin swab markers

  Swab analysis will be performed for beta HPV types 5,8,15,20,24,38.

  Day 126

Secondary Outcomes (12)

• Adverse events collected throughout the study

  Day 126

• 12-Lead ECGs performed at Screening and End of Study

  Day 126

• 12-Lead ECGs performed at Screening and End of Study

  Day 126

• 12-Lead ECGs performed at Screening and End of Study

  Day 126

• 12-Lead ECGs performed at Screening and End of Study

  Day 126

Study Arms (4)

ICVT

EXPERIMENTAL

Digoxin and Furosemide (0.125%)

Drug: ICVT Topical Gel

Furosemide

EXPERIMENTAL

Furosemide (0.125%)

Drug: Furosemide Topical Gel

Digoxin

EXPERIMENTAL

Digoxin (0.125%)

Drug: Digoxin Topical Gel

Placebo

PLACEBO COMPARATOR

Vehicle Gel

Drug: Vehicle Topical Gel

Interventions

ICVT Topical Gel DRUG

Digoxin and Furosemide (0.125%)

ICVT

Furosemide Topical Gel DRUG

Furosemide (0.125%)

Furosemide

Digoxin Topical Gel DRUG

Digoxin (0.125%)

Digoxin

Vehicle Topical Gel DRUG

Vehicle Gel

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maruho Co., Ltd.: lead

Study Sites (1)

Centre for Human Drug Research

Leiden, Netherlands

RECRUITING

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robert Rissmann, PhD

  Centre for Human Drug Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Rissmann, PhD

CONTACT

+ 31 71 5246 400; clintrials@chdr.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: September 26, 2018
• Study Start: October 22, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

NL (1)