E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Actinic Keratosis |
Aktinisk keratose |
|
E.1.1.1 | Medical condition in easily understood language |
Actinic keratosis (AK), is a common skin condition. that presents with small, red, rough, scaly flat spots. AKs have the potential to develop into cancerous lesions (squamous cell carcinomas).
|
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000614 |
E.1.2 | Term | Actinic keratosis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the local tolerability of daily applications of AVX001 gel in doses of 1% or 3% and compare with vehicle for 4 weeks of field-directed treatment of subjects with AK.
|
|
E.2.2 | Secondary objectives of the trial |
To evaluate safety of the daily application of AVX001 gel in doses of 1% or 3% for 4 weeks of field-directed treatment of subjects with AK.
To evaluate the efficacy of daily applications of AVX001 gel in doses of 1% or 3% and compare with vehicle for 4 weeks in field-directed treatment of subjects with AK.
To establish the dose-response efficacy relationship of daily applications of AVX001 gel in doses of 1% and 3% and vehicle for 4 weeks in field-directed treatment of subjects with AK.
To evaluate the treatment satisfaction of daily applications of AVX001 gel in doses of 1% or 3% compared with vehicle for 4 weeks in field-directed treatment of subjects with AK.
To evaluate the cosmetic outcome of daily applications of AVX001 gel in doses of 1% or 3% and compare with vehicle for 4 weeks in field-directed treatment of subjects with AK.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Participants must be≥ 18 years of age 2. Fluent in Danish 3. Actinic Keratosis (AK) diagnosed by Central assessors (based on uploaded photo) 4. Present an area of 25cm2 with 4 to 8 AK lesions located in face, neck or chest 5. AK lesions in target area severity grade 1 or 2 as defined by the Olsen clinical Criteria for AK 6. Able to and willing to follow trial procedures including application of AVX001 and using the Study App. 7. Have a suitable smartphone to complete the trial tasks (Android operating system: Android 8.0 or higher; iPhone with iOS 12.4 or higher 8. Female Subjects must either be of non-childbearing potential (either be surgically sterile (hysterectomy or tubal ligation) or post-menopausal) or must be using a highly effective method of contraception. Contraception must be maintained for the duration of the study.
|
|
E.4 | Principal exclusion criteria |
1. AK lesions classified as Olsen grade 3 in target area 2. Atypical AK lesions in the target area, including suspected SCC or BCC 3. Under suspicion of ,or current skin cancer diagnosis in the target area. subjects who had BCC, SCC or melanoma and have completed curative therapy at least 12 months prior to screening and are in remission can be considered to participate in the trial by investigator’s discretion 4. Any dermatological condition in the target area that can be exacerbated by treatment or affect trial assessments, including but not limited to psoriasis vulgaris AD, rosacea, urticaria, scabies, and herpes simplex 5. Received immunosuppressive/immunomodulating drugs including but not limited to methotrexate, cyclosporine, azathioprine, oral retinoids, 6 months prior to baseline visit. 6. Received systemic corticosteroids including but not limited to betamethasone, prednisone, dexamethasone, metilprednisolone (except if via inhale or intranasal delivery) 6 months prior to baseline visit. 7. Received lesion or field directed therapy within 2 cm of the target area for trial treatment one month prior to baseline visit, including topical drugs, including but not limited to topical fluorouracil, imiquimod, ingenol mebutate and diclofenac. destructive therapies, including but not limited to surgery, cryotherapy, dermabrasion, and photodynamic therapy field ablation treatments, including but not limited to chemical peels, laser resurfacing 8. Recipient of organ transplant including but not limited to bone marrow, kidney, liver, heart 9. Any unstable neurological or psychiatric disorder based on the investigator's opinion which has the potential to affect the safety of the subject, influence on trial objectives or impede the subject’s ability to complete the trial. 10. History of chronic alcohol or drug abuse within 12 months prior to screening or any condition associated with poor compliance at the investigator’s discretion 11. Received treatment with any non-approved drug substance within the last 4 weeks prior to baseline visit. 12. Known allergy or intolerance to fish, shellfish or fish oil 13. Concurrent participation in any other clinical trial or participation in any clinical trial treatments 4 weeks prior to enrollment. 14. Subject is pregnant or lactating
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects manifesting with LSR>2 at any time between Baseline and EOS. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Assessment of systemic safety based on reported SAE, AE, vital signs, skin examination.
Proportion of subjects who experience LSR grade 1, 2, 3 and 4 from Baseline to EOT, and EOS
Proportion of subjects experiencing a clinically visible clearance of target area of >50% as assessed in-clinic from baseline to the end of treatment visit (EOT) / early termination.
Proportion of subjects experiencing a clinically visible clearance of target area of >50% as assessed in-clinic from baseline to the end of the study visit (EOS).
Recurrence rate of AKs as assessed in-clinic after treatment clearance between EOT and EOS visits.
Appearance of new lesions in the target area as assessed in-clinic from Baseline to EOS.
Subject satisfaction with the AVX001 gel, assessed by TSQM at Week 2 and EOT.
Proportion of patients with a cosmetic outcome grade <2 from Baseline to EOS, as assessed using the Cosmetic ScoringTool.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
If it states EOS the timepoint is 12 weeks
If it states EOT the timepoint is 4 weeks |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |