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Actinic KeratosesPhase 1/2COAKSNCT05164393

Phase I/IIa Trial to Evaluate AVX001 Gel in Doses of 1% or 3% Compared With Vehicle Over Four Weeks of Field-directed Treatment Period in Adult Subjects With AK

A Phase 1/2 study testing AVX001 in people with Actinic Keratoses, run by Coegin Pharma AB at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Actinic keratosis (AK), also known as solar keratosis, is a common skin condition characterised by abnormal growth of skin cells caused by long-term sun exposure. AK is considered to be a precancerous lesion, and is therefore commonly treated to reduce the risk of malignant transformation into skin cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Actinic Keratoses
What is being tested?
AVX001
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteDenmark
Study dates
2 Nov 2021to Mar 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated informed consent
  • ≥ 18 years of age
  • Fluent in Danish
  • Clinical AK diagnosis confirmed by PI.
  • Present an area of 25cm2 with 4 to 8 AK lesions located in face, neck or chest AK lesions in target area severity grade 1 or 2 as defined by the Olsen clinical Criteria for AK
  • Able to and willing to follow trial procedures including application of AVX001 and using the Study App.
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  • Have a suitable smartphone to complete the trial tasks (Android operating system: Android 8.1 or higher; iPhone with iOS 12.4 or higher)
  • 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.
  • A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
  • A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. (CTFG 2020)
  • For women not taking hormonal contraception with amenorrhea for less than 12 months and just a single FSH measurement in postmenopausal range, a decision can be made by the PI whether it is appropriate for them to undergo a confirmatory FSH measurement or commence a highly effective method of birth control
  • Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly. (ICH 2009)
  • Such methods include:
  • Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation : oral, intravaginal, transdermal
  • Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
  • Intrauterine device (IUD)
  • Intrauterine hormone-releasing system ( IUS)
  • Bilateral tubal occlusion
  • Vasectomised partner.
  • Sexual abstinence.

Who cannot join

  • AK lesions classified as Olsen grade 3 in target area
  • Atypical AK lesions in the target area, including suspected SCC or BCC
  • 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
  • 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
  • Received immunosuppressive/immunomodulating drugs including but not limited to methotrexate, cyclosporine, azathioprine, oral retinoids, 6 months prior to baseline visit.
  • Received systemic corticosteroids including but not limited to betamethasone, prednisone, dexamethasone, methylprednisolone (except if via inhale or intranasal delivery) 6 months prior to baseline visit.
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  • 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
  • Recipient of organ transplant including but not limited to bone marrow, kidney, liver, heart
  • 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.
  • 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
  • Received treatment with any non-approved drug substance within the last 4 weeks prior to baseline visit.
  • Known allergy or intolerance to fish, shellfish or fish oil
  • Concurrent participation in any other clinical trial or participation in any clinical trial treatments 4 weeks prior to enrolment.
  • Subject is pregnant or lactating

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Bispebjerg Hospital

    Copenhagen, Region Sjælland, 2400

Other trials in Denmark

About this study

Official title: A Single-center, Randomized Double-blind, Vehicle-controlled, Dose-ranging Decentralised Clinical Trial to Evaluate the Safety and Efficacy of Daily Field-directed Topical Applications of AVX001 Silicone-based Gel in Doses of 1% or 3% in Adult Subjects With Multiple Actinic Keratosis Lesions Olsen Grade 1 or 2

Actinic keratosis (AK), also known as solar keratosis, is a common skin condition characterised by abnormal growth of skin cells caused by long-term sun exposure. AK is considered to be a precancerous lesion, and is therefore commonly treated to reduce the risk of malignant transformation into skin cancer.

The trial is a randomised, double-blind, vehicle-controlled, dose-comparison trial in which adult subjects with AK grade 1 or 2 will be treated with AVX001 silicone-based gel in doses of 1% or 3% or with a gel vehicle for a 4-week field-directed treatment period. Subjects will be followed up for 8 weeks after the treatment period. The primary objective is to evaluate the local tolerability of daily applications of AVX001 gel in doses of 1% or 3% and compare with vehicle.

Being tested
AVX001
Keywords
Actinic Keratosis, Olsen grade, Actinic Keratosis Field Assessment Scale, Local skin reaction, Topical treatment
Medical subject headings
Keratosis, Actinic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AVX001Drug

    Topical gel treatment for once daily application

Study groups in NCT05164393
Study groupRoleWhat they receive
AVX001 1%ExperimentalApplication of AVX001 1% gel to treatment field once daily
Receives: Drug: AVX001
AVX001 3%ExperimentalApplication of AVX001 3% gel to treatment field once daily.
Receives: Drug: AVX001
AVX001 VehiclePlacebo comparatorApplication of AVX001 vehicle gel to treatment field once daily
Receives: Drug: AVX001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects with local skin reaction (LSR) >2

    Measured: Baseline to end of study (12 weeks)

Secondary outcomes (14)

  1. Assessment of safety based on frequency of SAEs

    Measured: Baseline to end of study (12 weeks)

  2. Assessment of safety based on frequency of AEs

    Measured: Baseline to end of study (12 weeks)

  3. Assessment of safety based on skin examinations

    Measured: Baseline to end of study (12 weeks)

  4. Assessment of safety based on blood pressure (vital sign)

    Measured: Baseline to end of study (12 weeks)

  5. Assessment of safety based on pulse (vital sign)

    Measured: Baseline to end of study (12 weeks)

  6. Assessment of safety based on temperature (vital sign)

    Measured: Baseline to end of study (12 weeks)

  7. Proportion of subjects who experience LSR grade 1, 2, 3 and 4

    Measured: Baseline to End of Treatment and End of Study (week 4)

  8. Proportion of subjects experiencing a clinically visible clearance of target area of >50% as assessed in-clinic

    Measured: Baseline to the end of treatment visit (EOT) (week 4) / early termination.

  9. Proportion of subjects experiencing a clinically visible clearance of target area of >50% as assessed in-clinic

    Measured: Baseline to the end of the study visit (EOS, week 12).

  10. Recurrence rate of AKs as assessed in-clinic after treatment clearance

    Measured: Between End of Treatment (week 4) and End of Study visits (week 12).

  11. Appearance of new lesions in the target area as assessed in-clinic

    Measured: From Baseline to EOS (week 12)

  12. Subject satisfaction with the AVX001 gel, assessed by TSQM

    Measured: at Week 2 and EOT (week 4).

  13. Proportion of patients with a cosmetic outcome grade <2 , as assessed using the Cosmetic Scoring Tool.

    Measured: from Baseline to EOS (week 12)

  14. Cosmetic outcome of target area as evaluated by participants by comparing the status at EOS with a baseline photo

    Measured: Baseline and End of Study (week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2021
  2. Study start2 Nov 2021
  3. Primary completionMar 2022 (estimated)
  4. Study completionMar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05164393
Sponsor's protocol ID
AVXCLIN005
Other IDs
2021-000934-32
Acronym
COAKS
Status last verified
Jan 2022
First submitted
22 Nov 2021
Last updated
27 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ortner VK, Johansen B, Kilov K, Castillo Mondragon A, Duvold T, Kihl J, Ashcroft FJ, Feuerherm AJ, Pind Laugesen C, Marcker Espersen ML, Manole I, Isberg AP, Andersen AD, Rakvaag E, Zibert JR, Haedersdal M. The Copenhagen Actinic Keratosis Study (COAKS). A decentralised clinical trial to evaluate tolerability, safety and efficacy of daily field-directed topical treatment with cytosolic phospholipase A2 inhibitor, AVX001, in participants with actinic keratosis: protocol for a randomised controlled phase I/IIa trial. BMJ Open. 2022 Oct 5;12(10):e061012. doi: 10.1136/bmjopen-2022-061012.

    PubMed 36198452

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AVX001 in people with Actinic Keratoses, run by Coegin Pharma AB at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with local skin reaction (LSR) >2 (time frame: Baseline to end of study (12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05164393, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.

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