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Actinic KeratosisPhase 1NCT02600598

Biological Effects of LEO 43204 in Actinic Keratosis

A Phase 1 study testing LEO 43204 Gel, 0.037% in people with Actinic Keratosis, run by LEO Pharma at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase I, single-centre, open label, within-subject comparison trial to explore the biological effects of LEO 43204 Gel, 0.037%, applied once daily for 3 consecutive days in patients with actinic keratosis on the upper extremity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Actinic Keratosis
What is being tested?
LEO 43204 Gel, 0.037%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
Jul 2016to 16 Jan 2017
Phase
Phase 1
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

  • 1. Signed and dated informed consent has been obtained.
  • 2. Subjects with at least 5 non-keratotic, clinically typical, visible and discrete AK lesions within a contiguous 250 cm2 area (AK Treatment Area) on the upper extremity,
  • 3. Subjects with one additional AK lesion located on the contralateral arm.
  • 4. Subjects with an area of normal skin in close proximity to the AK Treatment Area or on the contralateral arm.
  • 5. Male and female subjects, 18 years or older.
  • 6. Agreement from the patient to allow photographs of the selected treatment area to be taken and used as part of the study data package
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  • 7. Ability to follow study instructions and likely to complete all study requirements
  • 8. Female Subjects must be of either
  • non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal litigation) or,
  • child-bearing potential* provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.
  • Female subjects are considered of child-bearing potential unless they have had a hysterectomy or have undergone tubal litigation or have been post-menopausal for at least one year prior to first visit.
  • 9. Female subjects of child-bearing potential must be willing to use effective contraception at trial entry and until completion.
  • Effective contraception is defined as follows:
  • Abstinence (when this is in line with the preferred and usual life style of the subject).
  • Vasectomised partner (given that the subject is monogamous).
  • An intrauterine device.
  • Double barrier method defined as two distinct methods (two actual barrier methods).
  • Hormonal contraceptive (oral hormonal birth control, oestrogenic vaginal ring, percutaneous contraceptive patches, implants and injectables) for at least one menstrual cycle prior to enrolment.

Who cannot join

  • 1. Prior treatment with ingenol mebutate gel in the treatment area within the last 12 months.
  • 2. Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme (presently LP0084-68, LP0084-1013, LP0084-1014, LP0084-1015, LP0084-1148, LP0084-1077, LP0084-1193, LP0084-1194, LP0084-1195, LP0084-1196).
  • 3. Location of the selected treatment area within 5 cm of an incompletely healed wound or infected area of the skin (excl. study related biopsies) or within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.
  • 4. History or evidence of skin conditions other than the study indication that would interfere with the histologically- or biomarker evaluation of the study medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum).
  • 5. Treatment area lesions that have an atypical clinical appearance (e.g. hypertrophic, hyperkeratotic, recalcitrant disease [had cryosurgery on two previous occasions] and/or cutaneous horns).
  • 6. Known sensitivity or allergy to any of the ingredients of LEO 43204 Gel (e.g. citric acid)
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  • 7. Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety during the course of the study, as determined by Investigator clinical judgment.
  • 8. Anticipated need for in-patient hospitalisation or in-patient surgery during the study period. Note that cosmetic/therapeutic procedures are not excluded if they fall outside of the criteria detailed in the Prohibited Therapies or Medications (listed below).
  • 9. Anticipated excessive or prolonged exposure to ultraviolet light (e.g. sunlight) or use of tanning beds for the duration of the study
  • 10. Current participation in any other interventional clinical trial
  • 11. Subjects who have received treatment with any non-marketed drug product (i.e. an agent which has not yet been made available for clinical use following registration) within the last two months.
  • 12. Subjects known to be infected with Human Immunodeficiency Virus (HIV).
  • 13. Subject known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state).
  • 14. Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial, or are breast feeding.
  • 15. Females of child-bearing potential with positive pregnancy test at [screening or visit 1].
  • 16. Previous enrolment in this clinical trial. Prohibited Therapies and/or Medications: within 2 weeks prior to the Screening visit
  • 17. Cosmetic or therapeutic procedures (e.g. use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 cm of the selected treatment areas and within 2 cm of the selected AK lesion outside the treatment area
  • 18. Use of acid-containing therapeutic products (e.g. salicylic acid or fruit acids, such as alpha and beta hydroxy acids and glycolic acids), topical retinoids or light chemical peels: within 2 cm of the selected treatment areas and within 2 cm of the selected AK lesion outside the treatment area
  • 19. Use of topical salves (non-medicated/non-irritant lotion/cream are acceptable) or topical steroids: within 2 cm of the selected treatment areas and within 2 cm of the selected AK lesion outside the treatment area; artificial tanners: within 5 cm of the selected treatment areas and within 5 cm of the selected AK lesion outside the treatment area Prohibited Therapies and/or Medications: within 4 weeks prior to the Screening visit
  • 20. Treatment with immunomodulators (e.g. azathioprine), cytotoxic drugs (e.g. cyclophosphamide, vinblastine, chlorambucil, methotrexate, podophyllin, camptothecin) or interferon/interferon inducers.
  • 21. Treatment with systemic medications that suppress the immune system (e.g. cyclosporine, prednisone, methotrexate, infliximab).
  • 22. Treatment/therapy with UVB
  • Prohibited Therapies and/or Medications: within 8 weeks prior to the Screening visit
  • 23. Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 2 cm of the selected treatment areas and within 2 cm of the selected AK lesion outside the treatment area Prohibited Therapies and/or Medications: within 6 months prior to the Screening visit
  • 24. Use of systemic retinoids (e.g. isotretinoin, acitretin, bexarotene)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Beacon Clinical Research, LLC

    Quincy, Massachusetts, 02169

  • Long Island Skin Cancer and Dermatology Surgery

    Smithtown, New York, 11787

Other trials in United States

About this study

Official title: Biological Effects of LEO 43204 in Actinic Keratosis Assessed by Histopathology

This is a Phase I, single-centre, open label, within-subject comparison trial to explore the biological effects of LEO 43204 Gel, 0.037%, applied once daily for 3 consecutive days in patients with actinic keratosis on the upper extremity. The treatment area for each patient will be as defined as a contiguous area of 250 cm2 of skin on the upper extremity (including the dorsum manus) that contains a minimum of 5 AK lesions. Additionally there must be at least one AK lesion located in a non-treated area on the contralateral arm. All eligible subjects will receive LEO 43204 Gel, 0.037%, on the treatment area on Days 1, 2 and 3. Study medication application will be (sub)investigator applied. A total of 30 patients will be enrolled into this study (n=15 in each of the two groups). Patients will be divided into two groups with different biopsy schedules.

Being tested
LEO 43204 Gel, 0.037%
Medical subject headings
Keratosis, Actinic

What participants receive

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

  • LEO 43204 Gel, 0.037%Drug

  • LEO 43204 Gel, 0.037%Drug

Study groups in NCT02600598
Study groupRoleWhat they receive
LEO 43204 Group AExperimentalGroup A - Experimental LEO 43204, applied once daily for 3 consecutive days in patients with actinic keratosis
Receives: Drug: LEO 43204 Gel, 0.037%
LEO 43204 Group BExperimentalGroup B - Experimental LEO 43204, applied once daily for 3 consecutive days in patients with actinic keratosis
Receives: Drug: LEO 43204 Gel, 0.037%

What is being measured

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

  1. Number of CD3+ T lymphocytes assessed by immunohistochemistry in biopsies from AK lesions 56 days after first treatment.

    Measured: 56 days

Secondary outcomes (7)

  1. Number of infiltrating cells assessed by immunohistochemical staining

    Measured: 8 weeks

  2. Expression of inflammatory and skin matrix modulation markers assessed by RNA expression and immunohistochemistry

    Measured: 8 weeks

  3. Expression of ICAM-1 (marker of vascular endothelium activation) assessed by immunohistochemical staining as area of section with positive staining.

    Measured: 8 weeks

  4. Expression of Ki-67 and K16 (markers of cell proliferation and differentiation) assessed by immunohistochemical staining as area of section with positive staining.

    Measured: 8 weeks

  5. Expression of cleaved caspase-3 (apoptosis) assessed by immunohistochemical staining as area of section with positive staining

    Measured: 8 weeks

  6. Necrosis of the epidermis and dermis in haematoxylin & eosin-stained sections (scored on 0-3 scale).

    Measured: 8 weeks

  7. Number of p53 gene mutations determined by DNA sequencing in normal and AK skin and blood at baseline and in a treated AK lesion at Week 8.

    Measured: 8 weeks

Timeline

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

  1. First posted9 Nov 2015 (estimated)
  2. Study startJul 2016
  3. Primary completion27 Dec 2016
  4. Study completion16 Jan 2017

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02600598
Sponsor's protocol ID
LP0084-1228
Status last verified
Apr 2018
First submitted
5 Nov 2015
Last updated
24 Feb 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LEO 43204 Gel, 0.037% in people with Actinic Keratosis, run by LEO Pharma at 2 sites in United States.

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 18 inclusion and 25 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: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of CD3+ T lymphocytes assessed by immunohistochemistry in biopsies from AK lesions 56 days after first treatment. (time frame: 56 days). 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 NCT02600598.

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 24 Feb 2025.

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