Characterisation of count of actinic keratosis during treatment with zyclara by non-invasive study with high definition optical coherence tomography (HD-OCT) and reflectance confocal microscopy (RCM)

• Conditions: actinic keratosis; MedDRA version: 17.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-005546-11-IT
• Lead Sponsor: DEPARTMENT OF DERMATOLOGY, UNIVERSITY OF MODENA AND REGGIO EMILIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-04
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

To be eligible, a patient must comply with all of the following criteria:
1.Immunocompetent Caucasian patient.
2.5-20 clinically evident AK lesions either on full face or balding scalp.
3.Male
or
female without child-bearing potential.
4.Having at least 1 AK and 1 subclinical lesion in the study area diagnosed by HD-OCT or RCM.
5.Willingness to have reflectance confocal microscopy examination and HD-OCT examination performed in treatment area.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

A patient is ineligible and must not enter the study if any of the following criteria is met:
Safety concerns:
1.Contraindications for Imiquimod treatment: Hypersensitivity to Imiquimod or to any of the excipients (isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), xanthan gum).
2.Broken skin in the study treatment area.
3.Autoimmune condition.
4.Severe haematological disease.

Lack of suitability for the study:
5.Presence of AK lesions in the STA with clinically excessive hyperkeratosis as seen in cutaneous horns.
6.Treatment of AKs in region of eyes, lips or nostrils
7.Any kind of AK treatment at the STA within the last 2 months prior to randomisation.
8.Presence of any histologically confirmed skin tumour in the STA: in situ SCC including Bowen’s disease, invasive SCC, basal cell carcinoma, or other malignant tumours.
9.Systemic immunomodulatory treatment such as interferon, azathioprine, cyclosporine, retinoids, any oral or injectable corticosteroids, or inhaled or nasal corticosteroids with dosages of >1200 µg/day beclomethasone or equivalent within 4 weeks before start of study treatment.
10.History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years which might hinder regular treatment and supervision and might lead to premature withdrawal from the study.
11.Mentally incapacitated patient.
12.Present or history of drug or alcohol abuse within the last 3 years.

Administrative reasons:
13.Exposure to an investigational product within the last 3 months.
14.Lack of ability or willingness to give informed consent.
15.Age below 18 years.
16.Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
17.Anticipated non-availability for study visits/procedures.
18.Vulnerable subjects (such as persons kept in detention)
19.The planned sample size has been reached.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In vivo characterization of the effect of Imiquimod 3.75% in the field of cancerisation of Actinic Keratosis by HD-OCT and RCM.;Secondary Objective: not applicable;Primary end point(s): To determine the capability of cellular-architectural resolution imaging to detect subclinical lesions and treatment reaction (Lmax) in Imiquimod 3,75% treatment field;Timepoint(s) of evaluation of this end point: Main objective is to detect subclinical lesions and to characterize their cellular substrate before the treatment (W0) and during the treatment with Imiquimod 3.75% (at W2, W4, W6) and after 8 weeks after end of treatment

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Main objective is to detect subclinical lesions and to characterize their cellular substrate before the treatment (W0) and during the treatment with Imiquimod 3.75% (at W2, W4, W6) and after 8 weeks after end of treatment;Secondary end point(s): to assess the overall treatment effect with zyclara (on visible and non-visible lesions) at a microscopic quasi histologic level.